M. McDermott, Donna M. Mendes, Nancy A. Nussmeier and Diane

Transcription

A Call to Action: Women and Peripheral Artery Disease : A Scientific Statement
From the American Heart Association
Alan T. Hirsch, Matthew A. Allison, Antoinette S. Gomes, Matthew A. Corriere, Sue
Duval, Abby G. Ershow, William R. Hiatt, Richard H. Karas, Marge B. Lovell, Mary
M. McDermott, Donna M. Mendes, Nancy A. Nussmeier and Diane Treat-Jacobson
Circulation published online February 15, 2012
Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX
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AHA Scientific Statement
A Call to Action: Women and Peripheral Artery Disease
A Scientific Statement From the American Heart Association
Endorsed by the Vascular Disease Foundation and its Peripheral Artery Disease Coalition
Alan T. Hirsch, MD, FAHA, Chair; Matthew A. Allison, MD, MPH, FAHA, Co-Chair;
Antoinette S. Gomes, MD, FAHA, Co-Chair; Matthew A. Corriere, MD, MS; Sue Duval, PhD;
Abby G. Ershow, ScD, FAHA; William R. Hiatt, MD, FAHA; Richard H. Karas, MD, PhD, FAHA;
Marge B. Lovell, RN; Mary M. McDermott, MD, FAHA; Donna M. Mendes, MD;
Nancy A. Nussmeier, MD; Diane Treat-Jacobson, RN, PhD, FAHA; on Behalf of the American Heart
Association Council on Peripheral Vascular Disease, Council on Cardiovascular Nursing, Council on
Cardiovascular Radiology and Intervention, Council on Cardiovascular Surgery and Anesthesia, Council
on Clinical Cardiology, and Council on Epidemiology and Prevention
L
ower extremity atherosclerotic peripheral artery disease
(PAD) has a very high prevalence in most nations and in
the United States.1– 8 Lower extremity PAD is now known to
be associated with equal morbidity and mortality and comparable (or higher) health economic costs as coronary heart
disease (CHD) and ischemic stroke.9,10 Yet where surveyed,
the public and clinicians (as well as health payers and
government agencies) do not yet fully recognize the risks
associated with PAD.11
For decades, clinicians did not recognize the impact of
coronary disease in women.12 As such, women were not
informed of their CHD risk. For any common disease,
whether infectious, oncological, or traumatic, when more
than half of the population at risk is not aware of this risk, and
when this risk is not managed, preventable morbid and mortal
events are inevitable.
Certain health facts are now evident: Women suffer the
consequences of PAD at rates at least as high as those
observed in men. But major knowledge gaps exist. Clinical
research to evaluate gender-based differences that might
underlie the delayed, postmenopausal presentation of PAD
in women has not been conducted. Whether subtle but
important gender-based distinctions in clinical presenta-
tions exist is unknown. The relative sensitivity and specificity of PAD diagnostic tests and pathways by gender are
unclear. Although there is suggestive evidence that treatment benefits and harms are different in women and men,
this cannot yet be confirmed from current clinical trial data
because of the limited inclusion of women in past
investigations.
Other facts provide encouragement. Women with or at risk
for CHD now better understand this risk. Thus, collation of
accurate PAD-specific health information for women is likely
to improve their own health and that of society at large.
The American Heart Association, in collaboration with
the Vascular Disease Foundation (and its “Peripheral
Arterial Disease Coalition”), commissioned this scientific
statement to summarize the evidence that describes the
epidemiological burden of PAD in women. The statement
also aims to describe the associated cardiovascular risk of
ischemic events, as well as the symptom classes and
clinical presentations that should be known to women; to
highlight the efficacy of current treatments; and to spotlight the challenges represented by the current low levels
of PAD awareness among target female populations. Finally, this statement reviews the current status of PAD-
The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside
relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required
to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.
This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on January 19, 2012. A copy of the
document is available at http://my.americanheart.org/statements by selecting either the “By Topic” link or the “By Publication Date” link. To purchase
additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com.
The American Heart Association requests that this document be cited as follows: Hirsch AT, Allison MA, Gomes AS, Corriere MA, Duval S, Ershow
AG, Hiatt WR, Karas RH, Lovell MB, McDermott MM, Mendes DM, Nussmeier NA, Treat-Jacobson D; on behalf of the American Heart Association
Council on Peripheral Vascular Disease, Council on Cardiovascular Nursing, Council on Cardiovascular Radiology and Intervention, Council on
Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, and Council on Epidemiology and Prevention. A call to action: women and
peripheral artery disease: a scientific statement from the American Heart Association. Circulation. 2012;125:●●●–●●●.
Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines
development, visit http://my.americanheart.org/statements and select the “Policies and Development” link.
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express
permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/
Copyright-Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page.
(Circulation. 2012;125:00-00.)
© 2012 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.org
DOI: 10.1161/CIR.0b013e31824c39ba
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by guest on February 16, 2012
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Circulation
March 20, 2012
specific risk messages in current women’s cardiovascular
health programs.
This statement presents a series of new evidence tables,
linked to the “ACC/AHA 2005 Practice Guidelines for the
Management of Patients With Peripheral Arterial Disease”
and the “2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral
Arterial Disease (updating the 2005 guideline).”13,14 Readers should refer to these guidelines as the best source of current
care recommendations. This statement is designed to:
●
●
●
●
Urge healthcare professionals to use the current vascular
review of symptoms, physical examination, and diagnostic
testing pathways to ensure that the PAD diagnosis is
promptly established in women “at risk” for having undiagnosed PAD
Urge individual clinicians and women’s cardiovascular
health programs to incorporate PAD-specific risk messages
in their current and future cardiovascular outreach efforts
that are targeted to women
Clarify the potential role of women in facilitating improved
national PAD awareness, as has occurred for other cardiovascular diseases (CVDs)
Promote the translation of the successful “Go Red for
Women” and Heart Truth campaigns for coronary artery
disease (CAD) awareness as models to achieve comparable
success for PAD
This statement was coauthored by a writing committee
composed of members of several American Heart Association councils, as well as the nonprofit Peripheral Arterial
Disease Coalition of the Vascular Disease Foundation. Together, we believe that this scientific statement is a “call to
action.” We hope these data and recommendations will
motivate specific actions to address this challenge and thus
help to improve PAD-related and global cardiovascular
health.
Epidemiology of PAD in Women
Prevalence of PAD
The population-based prevalence of PAD in women has
been incompletely evaluated. In contrast to the abundant
data defining the gender-specific prevalence of CAD and
stroke, few population surveys of PAD have been performed, and ongoing PAD surveillance is not currently
conducted in any state or nation. Thus, in calculating the
relative prevalence of PAD, it has been noted that many
population-based studies of PAD do not report prevalence
for women separately. In the published literature, the
results are mixed with respect to differences in prevalence
by gender. In a review by Higgins and Higgins,15 the
prevalence of PAD in women 45 to 93 years of age was
reported to range from 3% to 29% over this span of 5
decades.
To provide the most accurate gender-specific PAD prevalence estimates, this writing committee sought data from
individual participant data meta-analyses. These data are
adapted from Allison et al,16 who obtained raw data either
from publicly available data sets or by contacting the
Table 1.
US Population-Based Studies of PAD
Study
Years of Data
Collection
N
US State
Cardiovascular Health
Study17
1992–1993
5635
MD, PA, NC, CA
Multi-Ethnic Study of
Atherosclerosis18
2001–2003
6814
NY, MD, IL, CA, MN, NC
National Health and
Examination Survey19
1999–2002
4814
National sample
San Diego PAD20
1972–1976
602
CA
San Diego Population
Study21
1994–1998
2343
CA
Strong Heart Study22
1989–1992
4276
AZ, OK, ND, SD
Total
24 484
PAD indicates peripheral artery disease.
original investigators. Studies were included if both men
and women were studied and in which the presence of
PAD was determined objectively on the basis of the
measurement of an ankle-brachial index (ABI) ⬍0.9 in
participants who had no previous history of lower extremity
arterial revascularization. Using individual participant data metaanalytic methods, the pooled prevalence was calculated for men
and women separately (Table 1; Figure 1).
In this analysis, the prevalence of PAD increased with
age for both men and women. Beyond mere definition of
the prevalence of any atherosclerotic disease, there is
increasing interest in the population “burden” of these
syndromes (defined as the total number of individuals who
have the disease). Using US census data from 2010, the
burden of PAD was calculated (Figure 2) and showed that
there were more women than men with PAD among US
adults ⱖ40 years of age.
Mortality
Few prior studies have reviewed the gender-specific mortality of PAD. For the present scientific statement, data
were adapted from the ABI Collaboration study completed
by Fowkes et al.23 Studies were included if participants
were derived from a general population, ABI was mea-
Figure 1. Gender-specific prevalence of peripheral artery disease (PAD) by age group.
Hirsch et al
Women and Peripheral Artery Disease
3
and Higgins,15 gender-specific values were often inferred
from overall prevalence. Vavra and Kibbe24 reported the
mean prevalence in men and women from 8 studies but did not
apply appropriate meta-analytic techniques. Selection bias is
likely an issue in assessment of PAD in field surveys and clinical
trials, with the observation that elderly women are less prone to
attend such examinations and more likely to refuse ankle blood
pressure measurement.25,26
Summary Statements
Figure 2. Estimated gender-specific burden of peripheral artery
disease (PAD) by age group.
sured at baseline, and individuals were followed up for
total and cardiovascular mortality. Sixteen populationbased cohort studies of PAD were used, which included
480 325 person-years of follow-up of 24 955 men and
23 339 women. An individual participant data meta-analysis was conducted for studies that included subjects who
had no previous history of CHD.
These results demonstrate that the associations between
ABI values and total mortality, CVD mortality, and major
coronary events are similar in women compared with men
(Figure 3). Specifically, in women, the risks for morbidity
and mortality are increased with lower ABI values and with
values ⱖ1.40.
1. The gender- and age-specific prevalence of PAD has
not been clearly defined from published populationbased studies.
2. Although the age-dependent prevalence of PAD in adult
women is lower than for men, the total population
burden of PAD appears to be higher.
3. Cardiovascular mortality, all-cause mortality, and major
coronary event rates by gender have not been well
defined in population-based studies. A trend exists that
suggests higher event rates for women than for men for
individuals with an ABI ⬍0.90.
Future studies of PAD prevalence and risk should (1)
clearly define the methods by which PAD was ascertained;
(2) include gender-specific, and preferably age-specific, prevalence values; (3) evaluate the possibility of study-specific
selection bias; and (4) explicitly state how the blood pressure
measurements for the ABI were obtained and how the ABI
was calculated.
Clinical Presentation of PAD in Women
Leg Symptoms in Women
Methodological Challenges and Implications for
Future PAD Research
There are several challenges in evaluating the epidemiology of PAD in women from the existing literature. First,
although PAD prevalence is commonly reported from
clinical series, these studies do not provide a true
population-based prevalence. In a prior review by Higgins
Although intermittent claudication is considered a hallmark manifestation of lower extremity PAD, it is well
established that many patients with PAD do not present
with classic symptoms.2,27,28 Many people with PAD are
asymptomatic (defined as absence of exertional leg symptoms in the presence of an ABI ⬍0.90), whereas others
have atypical leg symptoms (for example, leg muscle
Figure 3. Hazard ratios (unadjusted) of
all-cause mortality, cardiovascular mortality, and major coronary events (coronary
death, nonfatal myocardial infarction) in
men and women, by ankle-brachial index
value. Hazard ratios were calculated with
the 1.1 to 1.2 group as the reference
(hazard ratio⫽1.0).
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March 20, 2012
symptoms that are present at rest and with exercise).2,27
This fact alone, not recognized until approximately 1
decade ago, has fundamentally altered perceptions of the
prevalence and risk of PAD in both genders by clarifying
that there is a long “latent phase” in which systemic CVD
progresses and that is difficult to detect by routine clinical
histories. In this regard, the presence of asymptomatic
PAD and atypical exertional leg symptoms has been
observed in both men and women.2,27–30 For example, in
the Women’s Health and Aging Study (WHAS) of 933
disabled women ⱖ65 years of age, 328 (35%) had an ABI
⬍0.90, which established the diagnosis of PAD.28 Of these
328 women with PAD, 63% had no exertional leg symptoms. Thus, asymptomatic PAD is common among older
women.
Although both men and women with PAD can be either
asymptomatic or present with atypical leg symptoms,
gender differences in the prevalence of specific leg symptoms among patients with PAD have been reported. In a
population study of 5080 Swedish men and women 60 to
90 years of age, asymptomatic PAD was more common in
women than in men (12.6% versus 9.4%, P⫽0.03).30
Similarly, in the Walking and Leg Circulation Study
(WALCS) cohort of 460 PAD participants without critical
limb ischemia identified from Chicago (IL)-area medical
centers, the 187 women were more than twice as likely as
the men to report the presence of atypical exertional leg
symptoms that sometimes began at rest.29 There were,
however, no significant differences in the prevalence of
asymptomatic disease between men and women with PAD
in the WALCS cohort.29
Natural History of Lower Extremity Outcomes in
Women With PAD
People with PAD have greater lower extremity functional
impairment (ie, limitations in the ability of an individual to
participate in social and occupational spheres of life),
faster functional decline, and greater mobility loss than
those without PAD.27,31,32 Women with PAD have greater
functional impairment than women without PAD.28,33,34
Furthermore, women with PAD have greater lower extremity functional impairment than men.29,34 –36 For example, in
a cohort of 560 people with confirmed PAD and intermittent claudication, including 72 women, treadmill distance
to onset of intermittent claudication symptoms was 33%
shorter and maximal treadmill walking distance was 23%
shorter in women than in men.35 In the WALCS cohort,
women with PAD had slower walking speed and achieved
significantly shorter distances in the 6-minute walk than
men.29 In a primary care setting of men and women ⱖ50
years of age, women with PAD had poorer quality-of-life
scores than men with PAD.34 Several possible reasons have
been hypothesized for the poorer functional performance
among women with PAD than among men with PAD,
including lower gender-based leg strength, poorer cardiopulmonary fitness, and reduced calf muscle hemoglobin
oxygen saturation in women with PAD compared with men
with PAD.29,35,36
In prospective analyses, lower ABI values predict
greater decline in walking-related disability among
women. Among 847 women in the WHAS cohort, women
with baseline ABI values ⬍0.60 had a significantly higher
incidence of disability for the outcomes of walking a
quarter mile, walking velocity, and the number of city
blocks walked during the past week than women with
baseline ABI values of 0.90 to 1.50.37 Results of a recent
longitudinal study in which PAD participants were followed for up to 4 years demonstrate that women with PAD
have higher rates of mobility loss and functional decline
than men with PAD.38
Although women with PAD have greater functional
impairment than men with PAD, women may be less
likely to undergo lower extremity revascularization than
men.39 A single-center study of 1987 women with PAD
reported significantly lower rates of lower extremity revascularization compared with men with PAD after the
exclusion of patients with critical limb ischemia.39 A more
recent study from the same institution reported that lower
extremity revascularization rates in 592 PAD patients with
no prior history of revascularization were 22% for men and
16% for women, a difference that was not statistically
significant.40
Ethnic and Social Distribution of Clinical
Presentation in Women With PAD
In almost all health issues, gender and ethnicity serve as
factors that modify clinical presentation and societal treatment of disease. Ethnic-related differences have been documented in the prevalence and treatment of PAD.40 – 47 Minority women fare worse than white women in terms of health
status and rates of disability and mortality, as do minority
men. Diabetes mellitus is a well-known risk factor for PAD,
and diabetes mellitus-specific preventive care among women
is low.48 In some minority populations, the interaction of
biology and environment results in a higher prevalence of
diabetes mellitus, more advanced PAD at presentation, and a
greater proportion of minority women with PAD.32,49 The
preponderance of chronic diseases that are influenced by diet
and physical inactivity, such as type 2 diabetes mellitus,
obesity, and hypertension, rather than by factors known to
have a significant heritable component suggests that the
disparity in risk factors is more strongly related to social
determinants of disease.50 In a post hoc analysis of the
PREVENT III (Project of Ex Vivo Vein Graft Engineering
via Transfection III) trial, a multicenter trial that evaluated the
results of vein bypass surgery for chronic critical limb
ischemia, the impact of gender and ethnicity was evaluated.42
This study cohort included 249 black patients, including 131
men and 118 women. Graft failure rates were highest in black
women, with an increased risk of graft thrombosis (hazard
ratio [HR] 2.02 for secondary patency, 95% confidence
interval [CI] 1.27–3.20, P⫽0.003) and an increased risk for
major amputation (hazard ratio 2.38, 95% CI 1.18 – 4.83,
P⫽0.016) at 1 year. Similarly, Hispanic ethnicity has been
reported to be an independent predictor of limb loss in
patients undergoing autogenous infrainguinal bypass.45 In
Hirsch et al
summary, gender, race, and ethnicity appear to be synergistic
determinants of vein graft failure and limb loss.
Previous data suggest that socioeconomic status may
also represent a major factor that determines access to
preventative services and the eventual outcome of treatment of PAD. Current evidence suggests that lower socioeconomic status may lead to environmental exposures that
result in higher rates of obesity, physical inactivity, and
increased risk of diabetes mellitus.50 In both men and
women participating in the Heinz Nixdorf Recall Study (a
population-based prospective cardiovascular cohort study
in the Ruhr area in Germany), the ABI was lower and the
prevalence of PAD was higher among participants with
lower education levels.51 More specifically, study participants with a low level of education (odds ratio 2.58, 95%
CI 1.53– 4.34) or a medium level of education (odds ratio
1.90, 95% CI 1.27–2.85) had higher odds of having PAD
than participants with a high level of education. Additional
adjustment for classic atherosclerotic disease risk factors
reduced the strength of this association, although it remained significant. Current smoking, diabetes mellitus,
and a high body mass index were the most relevant
potential mediators of the association of lower education
with a higher PAD prevalence. It has been suggested that
diabetes mellitus prevention, weight management, and
smoking prevention and cessation programs should be
specifically targeted to individuals of lower socioeconomic
status.51
Currently, women and ethnic minorities are underrepresented in essentially all PAD prospective randomized controlled trials.52 There may be a reluctance of women (and
possibly also patients in some ethnic groups) to participate in
cardiovascular clinical trials.53 Efforts to enroll women of
diverse ethnic groups in such trials should be expanded,
because further investigation is needed to determine why
these subgroups have higher prevalence and worse outcomes
of treatment of PAD.
Potential Role of All Caregivers in Providing
Access to PAD Information
Women are more likely to obtain primary care than men.54
Regular visits by women to primary care physicians or
gynecologists for primary preventive care provide a potential
opportunity to screen at-risk women for PAD. Provision of
educational information to physicians who provide primary
care to women (including gynecologists, podiatrists, and
internal medicine and family physicians, as well as nurse
practitioners and physician assistants) may help improve
PAD diagnosis rates and thereby effect early detection and
treatment of PAD. However, as noted above, many women
with PAD do not present with classic symptoms of intermittent claudication. Furthermore, the physical examination by
the nonvascular specialist is known to be relatively insensitive to the diagnosis of PAD.55 Inasmuch as an accurate PAD
diagnosis can therefore only be confidently established by use
of objective testing, the ABI (documented to be more sensitive for the diagnosis of PAD than claudication symptoms
alone in women) should be more widely used by all primary
care clinicians and gynecologists. Although a large,
5
population-based trial assessing the net benefit, harm, and
cost-effectiveness of PAD screening has not been performed,
it would seem prudent for the ABI to be used to provide a
prompt diagnosis in “high-risk women”13 so that the known
gender-based cardiovascular health disparities are not reproduced in women as occurred for CAD in decades past.
Gender-Specific Access to Cardiovascular Health
Care: Current Sites of Care for Women
With PAD
The evidence base has long documented that PAD is highly
prevalent in women, and the data in the present report
(Epidemiology of PAD in Women) now suggest that the
total population burden of PAD may be higher in women
than in men. Yet this burden has seemed invisible to
clinicians, health systems, payers, and government agencies, because gender-based PAD health service analyses
have rarely been performed. The writing committee, working with the staff of the National Heart, Lung, and Blood
Institute (NHLBI), have compiled contemporary data that
document rates of visits by women and men at each major
site of care, including physicians’ offices, outpatient clinical departments, emergency departments, and inpatient
hospital discharges (Table 2). These data demonstrate that
women experience treatment for PAD in numbers similar
to men. For example, in 2007, 1.1 million physician office visits
by women and 1.1 million visits by men were reported to be
related to PAD diagnoses (National Ambulatory Medical Care
Survey, National Center for Health Statistics; http://www.cdc.
gov/nchs/ahcd/about_ahcd.htm). These data also demonstrate
that there are an equal number of visits by women for PAD
in the outpatient office setting as for stroke and that PAD
care, for women and men, is much more likely to be
delivered in the outpatient setting. In contrast, 5%, 10%,
and 18% of PAD, CAD, and stroke care, respectively,
occurs in the inpatient setting. This new data source
clarifies that at each of these points of PAD care, but
especially in the outpatient office setting, women could
easily be provided access to preventative information,
testing, and care, as well as access to participation in future
PAD clinical trials.
Summary Statements
1. Most women with PAD, like men, do not have classic
symptoms of intermittent claudication.
2. Women with PAD have greater functional impairment
and a more rapid functional decline than women without PAD.
3. Women (and particularly black females) are more likely
than men to experience graft failure or limb loss.
4. There is a need to identify women with or at risk for
PAD, especially black women, to lower cardiovascular
ischemic event rates, loss of independent functional
capacity, and ischemic amputation rates.
5. Women in the United States attend as many or more
PAD physician visits as men, which confirms the very
large burden of PAD in women.
6. Women predominantly see doctors and other clinicians
for PAD in the outpatient office setting.
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March 20, 2012
Table 2.
in 2007
Gender-Specific Sources of Cardiovascular Health Care (PAD, CHD, and Stroke)
Healthcare Setting*
Both Men and Women, n (%)
Men, n (%)
Women, n (%)
2 283 538 (88.7)
1 136 134 (86.7)
1 147 404 (90.9)
PAD†
Physician office visits
Outpatient department visits
129 783 (5.0)
87 459 (6.7)
42 324 (3.4)
Emergency department visits
34 144 (1.3)
20 295 (1.6)
13 849 (1.1)
Inpatient hospital discharges
125 996 (4.9)
67 285 (5.1)
58 711 (4.7)
2 573 461
1 311 173
1 262 288
13 151 997 (80.7)
8 297 578 (81.3)
4 854 419 (79.6)
1 006 215 (6.2)
666 414 (6.5)
339 801 (5.6)
564 199 (3.5)
271 012 (2.7)
293 187 (4.8)
1 574 379 (9.7)
965 355 (9.5)
609 024 (10.0)
16 296 790
10 200 359
6 096 431
2 952 768 (64.3)
1 645 130 (68.9)
1 307 638 (59.3)
Total
CHD†
Total
Stroke†
158 130 (3.4)
653 554 (14.2)
303 818 (12.7)
349 736 (15.9)
827 603 (18.0)
370 707 (15.5)
456 896 (20.7)
Total
4 592 055
66 857 (2.8)
2 386 512
91 273 (4.1)
2 205 543
PAD indicates peripheral artery disease; CHD, coronary heart disease.
*The healthcare settings are mutually exclusive, with no overlap. Details on the sampling methods of each survey
are available online: National Hospital Discharge Survey (NHDS), http://www.cdc.gov/nchs/nhds/about_nhds.htm;
National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey
(NHAMCS), http://www.cdc.gov/nchs/ahcd/about_ahcd.htm.
†PAD was defined as a primary diagnosis ICD-9 (International Classification of Diseases, 9th Revision) code of
440.20 – 440.24, 440.30 – 440.32, 440.4, 440.9, 443.9, or 445.02; CHD as a primary diagnosis ICD-9 code of
410 – 414 or 429.2; and stroke as a primary diagnosis ICD-9 code of 430 – 438.
Data sources: NAMCS and NHAMCS: The denominators used to calculate 2007 visit rates were US Census
2000 – based postcensal estimates of the civilian noninstitutionalized population of the United States on July 1,
2007. The total population on this date was approximately 296 302 000. NHDS: The denominator used to
calculate 2007 discharge rates was the civilian population of the United States on July 1, 2007. The total
population on this date was approximately 300 466 000.
Courtesy Michael Mussolino, PhD, and Paul Sorlie, PhD, National Heart, Lung, and Blood Institute.
PAD Diagnostic Methods in Women
The diagnosis of PAD is best established in all individuals
by a vascular history and physical examination, supported
by targeted measurement of the ABI.13,56 For selected
patients in whom incremental anatomic localization information will lead to a change in care strategy, duplex
ultrasound and advanced imaging studies may be used to
evaluate the location and severity of disease. These pathways, in the context of the current evidence base, are
identical for women and men.
The ABI test is indicated for use in all individuals at
high risk of PAD regardless of gender, as well as in
individuals with exertional limb symptoms, abnormal
lower extremity pulses, diabetes mellitus, or known CHD
or cerebrovascular disease. A Doppler ultrasound or oscillometric device is used to locate and measure the systolic
blood pressures in the arms and at both pedal pulses.
Specifically, using a Doppler probe and starting at the right
arm, systolic blood pressures are obtained in the right
brachial, right anterior tibial, right posterior tibial, left
posterior tibial, left anterior tibial, and left brachial arter-
ies. For each leg, the ABI should be calculated by dividing
the higher of the posterior and anterior tibial pressures by
the higher arm blood pressure. Although there are several
different methods that might be used to calculate the ABI
values, clinicians and vascular laboratories should use a
common method.56
No studies to date have examined differences in the
techniques used to measure the ABI between men and
women. Nevertheless, the posterior and anterior tibial
systolic pressures in women and men are known to be
slightly different because of gender-based height differences. For instance, when a subset of participants in the
Multi-Ethnic Study of Atherosclerosis (MESA) who were
free of CVD risk factors and subclinical atherosclerosis
were analyzed, women had ⬇0.02 lower ABI values than
men in the fully adjusted model, a result that to date is not
known to be associated with any diagnostic clinical
significance.46
There are no known gender-based differences in the
diagnostic sensitivity or accuracy of any of the physiological or classic imaging-based diagnostic PAD tests. Pulse
volume recordings, toe-brachial indices, segmental pres-
Hirsch et al
sure studies, and lower extremity arterial duplex ultrasound studies may all be used to document the presence of
PAD in women, as documented in the “ACC/AHA 2005
Practice Guidelines for the Management of Patients With
Peripheral Arterial Disease.”13
Similarly, there are no documented gender-based differences in the diagnostic sensitivity or accuracy of advanced
PAD anatomic imaging techniques (eg, magnetic resonance angiography [MRA], computed tomographic angiography, or conventional catheter-based arteriography).
MRA can provide a noninvasive anatomic map of the
lower extremity arterial circulation after the injection of
contrast, outlining luminal diameters.57–59 MRA studies do
not provide clear delineation of arterial wall calcification.
MRA can provide diagnostic images without exposure to
ionizing radiation. However, in patients with a low glomerular filtration rate (⬍30 mL/min/1.73 m2), there is a
low but serious risk of nephrogenic systemic fibrosis from
administration of gadolinium. Also, MRA is not routinely
recommended for individuals with implanted pacemakers
and may not be suitable in other patients with implanted
metallic devices.
Computed tomographic angiography can provide higher
resolution and may provide better visualization of both the
vessel lumen and arterial wall than can be demonstrated
with MRA. With appropriate timing, visualization of the
entire peripheral arterial tree can be obtained.60 – 62
Computed tomographic angiography may also define arterial calcification, which may be of help in planning invasive
treatment strategies; however, the presence of dense calcification may also limit the assessment of the magnitude of an
arterial stenosis.61,62 It is a first-pass technique, and contrast
volume limitations preclude multiple injections. Computed
tomographic angiography requires the use of ionizing radiation and administration of iodinated contrast, which limits its
safe use in individuals with renal dysfunction.
Conventional catheter-based digital subtraction arteriography is still performed as a diagnostic test for individuals with
PAD, but this is now rarely required because of the availability and accuracy of the noninvasive arterial imaging techniques. As such, invasive angiography is now usually performed only at the time of endovascular treatment to confirm
the noninvasive findings and to assess the immediate results
of endovascular procedures.
Despite the observation that native arterial diameters for
woman are smaller than for men of the same age,63 the
published evidence base does not demonstrate a differential
accuracy of stenosis assessment by gender.64 No published
studies have been designed or completed specifically to
evaluate gender-based diagnostic accuracy.
Summary Statements
1. Although normal ABI values in women are ⬇0.02
lower than for men, there are no gender-based differences in PAD diagnostic thresholds.
2. Arterial diameters in women are smaller than agematched segmental diameters in men.
7
3. Current data suggest that women with suspected PAD
may achieve identical utility from all physiological and
anatomic vascular diagnostic testing strategies as men.
Treatment of Symptomatic PAD in Women
The principal components of symptomatic PAD treatment
include pharmacological therapy, supervised exercise therapy, lower extremity revascularization, and pneumatic
lower extremity compression (Table 3). Although cardiovascular risk reduction is a critical goal in the management
of all patients with both symptomatic and asymptomatic
PAD, this topic is beyond the scope of the present
scientific statement, which focuses on symptomatic disease management from a gender-based perspective. Guidance for the primary prevention of cardiovascular events in
asymptomatic populations can be found in the “AHA
Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update.”65
Pharmacological Treatment
Cilostazol
Cilostazol is the only pharmacological treatment option
approved by the US Food and Drug Administration that
has consistently demonstrated symptomatic improvement
in claudication. There have been 6 published trials with
1582 participants, including 370 women (23.4%), that
support the efficacy of cilostazol over placebo66 –70 and
pentoxifylline71 for improving claudication onset and peak
walking time/distance. One additional safety study with
1435 participants included 495 women (34.5%) and demonstrated no increased mortality with cilostazol versus
placebo over up to 3.5 years of follow-up.72 Meta-analyses
and systematic reviews have demonstrated improvement in
claudication onset distance and peak walking distance,73,74
as well as quality of life.75 A recent pooled analysis of 6
published and 3 unpublished trials by Pande et al76
included 2251 subjects with 532 women (23.63%) and
demonstrated a 40-meter improvement in peak walking
distance over an average of 20.4 weeks of follow-up.
Gender-specific analyses demonstrated no statistical difference in estimated treatment effects between men (1.17,
95% CI 1.12–1.22) and women (1.10, 95% CI 1.02–1.19).
Thus, there was no gender-by-treatment interaction for
women in response to cilostazol.
Supervised Exercise
There is a considerable body of evidence, including 37
identified randomized trials49,77–112 and 7 systematic reviews or meta-analyses,113–119 demonstrating the efficacy
of supervised exercise to improve symptoms of claudication and exercise performance. These studies included a
total of 1814 participants, 1148 of whom performed
supervised exercise. Five of the studies (14%)77– 81 did not
report the gender of participants. In the remaining 32
studies, there were a total of 493 female participants,
averaging 27.2% of the total (range 0% to 81%).
The majority of the randomized trials (n⫽23), which
included a total of 991 (range 12–156) participants, compared
1 or more methods of supervised exercise training (treadmill
8
Circulation
Table 3.
March 20, 2012
Impact of Gender on PAD Treatment Outcomes
Total
Participants,
N
Type of
Intervention
Randomized
Studies, N
Supervised
exercise
37
1814
PWT/D; COT/D; 6-min walk test
Cilostazol
Pooled analysis
of 9 (6
published, 3
unpublished)
2251
PWT/D; COT/D
Surgical
revascularization
40
16 324
Endovascular
revascularization
22
Surgical and
endovascular
revascularization
7
Primary Outcomes Measured
Studies Reporting
Gender of
Participants, n (%)
Female Participants, n
(%)
Studies Reporting
Gender-Specific
Results, n (%)
31 (86)
493 (27; Range 0 – 81)
1 (3)
532 (24; Range 16–25)
None individually;
pooled analysis
of all studies
9 (100)
4467 (Range 0–60)
12
Gender-Specific Results
Reported
Insufficient data
No gender-by-treatment
interaction
Patency, repeat operation, limb salvage,
survival, amputation-free survival,
adverse events, ABI, digital pressure,
PWT/D, blood flow, QOL
34 (85)
No gender-by-treatment
interaction (n ⫽ 6); decreased
patency in women (n ⫽ 3);
increased perioperative adverse
events in women (n ⫽ 1);
gender-race interaction with
decreased patency in black
women (n ⫽ 1); gender–graft
diameter interaction effect on
patency (n ⫽ 1)
2665
Patency, technical success, repeat
intervention, limb salvage,
amputation-free survival, recurrent
ischemia, symptoms, adverse events,
ABI, ankle pressure, biomarkers, QOL,
functional outcomes, PWT/D, COT/D
19 (86)
847 (Range 20–50)
None
None
1506
Patency, adverse events, survival,
amputation-free survival, ABI
5 (71)
393 (Range 0–40)
None
None
PAD indicates peripheral artery disease; PWT/D, peak walking time/distance; COT/D, claudication onset time/distance; ABI, ankle-brachial index; and QOL, quality
of life.
Note: Citations are detailed in “Treatment of Symptomatic PAD in Women” section.
walking, resistance training, arm or leg cycling, StairMaster,
polestriding) or control. There were a total of 234 reported
female participants (mean 26%, range 0% to 48%). The
duration of exercise programs ranged from 6 weeks to 6
months, and most of these studies reported significant improvement in claudication onset time/distance and peak
walking time/distance in the exercise groups, particularly in
those groups that performed some form of aerobic exercise
training. However, none of these studies reported genderspecific analyses or outcomes.
Several studies compared supervised treadmill or walking
training (ranging between 3 weeks and 15 months) to either
surgical91 or endovascular revascularization,78,92–95 alone or
combined. In total, there were 562 (range 36 –150) participants in these studies, 307 of whom participated in supervised
exercise; female participants totaled 184 (32%, range 21% to
45%). Most studies reported significant improvement in both
the supervised exercise and revascularization arms of the
studies. Only 1 study91 reported results of gender-specific
analyses and noted that gender did not significantly influence
walking performance after treatment.
Several trials compared supervised exercise with pharmacological therapy, including antiplatelet medications,96 pentoxifylline,79,97 prostaglandin E1,97 and iloprost.98 Seventyseven of the 128 participants participated in supervised
exercise, and 21 (16% overall; range 0% to 33%) were
women. Overall, these studies reported comparable improvement in exercise versus drug therapy, with the greatest
increase in walking distance observed in those who received
combination therapy versus either therapy alone. However,
comparisons across studies are difficult because of the variability of treatment duration (2 weeks to 6 months). One
study79 described age- and gender-matched intervention
groups; however, there were no gender-specific analyses or
outcomes reported.
Studies comparing supervised versus home or unsupervised exercise108 –111 have included 151 participants, 48 of
whom (32%; range 0% to 47%) were women. Most demonstrated greater improvement in supervised versus home exercise, although 1 study111 reported similar increases in peak
walking distance between groups. Finally, 1 study120 (n⫽34;
7 women [20.6%]) found significant improvement in peak
walking distance and claudication onset distance after 6
months of pneumatic compression or supervised treadmill
training versus unsupervised exercise. Similar to previously
described trials, gender-specific analyses or outcomes were
not discussed. Although there is no evidence to suggest that
women respond differently than men to supervised exercise
training, additional studies are needed to establish whether
gender-based differences exist.
Lower Extremity Revascularization
Gender Representation in Lower Extremity
Revascularization for Symptomatic PAD
The evidence that describes the efficacy of lower extremity
revascularization for PAD is largely derived from study
populations that are predominantly male. Approximately 86%
of randomized clinical trials of surgical or endovascular
treatment for PAD report participant gender.42,78,91,92,94,121–185
Among contemporary PAD revascularization studies that
reported gender, women accounted for 32% of randomized
trial participants (range 0% to 54%),* 37% of prospective
*References 42, 91, 92, 94, 121–131, 133–140, 146, 147, 149 –161, 163–165,
168 –177, 179 –182, 184, 186 –188.
Hirsch et al
cohort study participants (range 18% to 57%),63,175,189 –217 and
37% of retrospective study participants (range 1% to
63%).39,40,218 –276 Hoel et al52 similarly observed participant
gender reporting in only 85% of vascular surgery clinical
trials in the United States and concluded that women are
underrepresented relative to their frequency of procedural
intervention. Lower interest in clinical trial participation
among women has been reported among patients with CHD
and may account in part for enrollment disparities,53 but the
relationship between gender and willingness to participate in
clinical research has not been characterized in patients with
PAD.
Gender and Patient Selection for Lower
Extremity Revascularization
Gender-based differences in demographic, comorbidity, and
anatomic characteristics among patients with PAD may
reflect patient selection factors that contribute to lower
revascularization rates in women. In their study of patients
with abnormal vascular laboratory studies and no prior
history of lower extremity revascularization, Feinglass et al39
observed that men were more than twice as likely to be
selected for revascularization despite similar baseline comorbidities and prevalence of limb salvage indications. Egorova
et al277 found a lower rate of procedural revascularization in
women during inpatient hospitalization for PAD (46% versus
54%), although others have reported similar rates of revascularization between genders.40 Several studies have observed that women undergoing lower extremity revascularization for PAD are older,63,192,224,246,262 have more advanced
disease,234,262,277 and have a lower prevalence of smoking63,246,262 than men. Hultgren et al246 reported a higher
proportion of suprainguinal procedures among women undergoing revascularization for PAD (44% versus 19%); conversely, others have reported lower rates of bypass to tibialevel outflow vessels in women.224 These contrasts in
procedural management were attributed to gender-specific
patient selection criteria and anatomic disease distributions.
Women with PAD have smaller tibial arteries,63 which may
be perceived as a factor that increases the technical difficulty
associated with distal revascularization. Higher rates of emergent hospital admission and nursing home discharge in
women with PAD have also been observed277 and may reflect
disparities in family or social support available to women
who are considering elective revascularization. Differences in
epidemiology, clinical presentation, and awareness of PAD in
women are outlined elsewhere in the present statement and
may also contribute to differential patient selection for lower
extremity arterial revascularization.
Influence of Gender on Outcomes Associated With
Revascularization for PAD
Patency
Several studies have observed inferior patency for women
after surgical lower extremity revascularization.63,132,221,278 In
their analysis of patients with aortoiliac occlusive disease
treated with a combination of surgical and endovascular
techniques, Ballard and colleagues221 found a relative risk of
4.6 for bypass or stent thrombosis in women. Green et al143
9
observed a gender-specific relationship between graft size
and thrombosis among patients treated with prosthetic aboveknee femoropopliteal bypass; 5-year cumulative patency rates
in that report were 69.1% versus 37.9% for men with large
versus small grafts and 45% for women in both graft-size
categories. Nguyen and colleagues42 observed an interaction
between race and gender as predictors of patency after lower
extremity saphenous vein bypass, with black women having
the greatest disadvantages in terms of graft loss (hazard ratio
2.02, 95% CI 1.27–3.20) at 1 year. Although these reports
suggest inferior patency in women (particularly among those
treated with surgical bypass), other studies of patency after
lower extremity revascularization for PAD have not identified significant gender effects in patients treated with endovascular procedures,† surgical bypass,‡ or combinations of
these revascularization techniques.251
Survival
Associations between gender and survival after lower extremity revascularization for PAD are complex and appear to be
influenced by differences in age, comorbidities, and procedural factors. In their retrospective analysis of lower extremity saphenous vein bypasses, Belkin et al224 reported lower
perioperative mortality in women. Magnant et al278 reported
similar perioperative mortality rates among men and women
undergoing infrainguinal bypass for lower extremity ischemia
but decreased long-term survival in women (54% versus 72%
3-year survival for women versus men, respectively); these
authors also observed a gender-dependent effect of diabetes
mellitus, with increased mortality in diabetic women. Egorova et al277 noted an increased hospital mortality rate in
women with PAD treated with procedural interventions and
observed the highest mortality risk in women undergoing
surgical revascularization and amputations. Hultgren et al245
identified an interaction between female gender and age as
predictors of perioperative mortality among patients undergoing surgical or endovascular procedures for lower extremity ischemia; age adjustment rendered a univariate association
between gender and mortality nonsignificant in their study,
and female gender was actually associated with improved
long-term survival in multivariable analysis. Others have
reported no gender effect on survival after treatment with
endovascular234 or open surgical42,197,238,280 techniques.
Reported gender effects on survival after lower extremity
PAD revascularization, therefore, have been inconsistent.
Gender is often a confounder for morbidity, age, and procedural factors that impact perioperative mortality and survival,
and these factors should be taken into account when revascularization procedures are considered in women with PAD.
Amputation-Free Survival
Multiple studies have reported similar amputation-free survival after lower extremity revascularization for PAD in men
and women.§ In their analysis of California hospital discharge data, Feinglass et al 238 observed improved
amputation-free survival over a mean follow-up of 61.5
months after lower extremity bypass in women versus men
†References 194, 234, 242, 247, 256, 267, 268, 270.
‡References 142, 150, 154, 156, 164, 196, 224, 225, 276, 279, 280.
§References 63, 196, 223, 224, 234, 245, 246, 258, 280.
10
Circulation
March 20, 2012
(male hazard ratio 1.15, 95% CI 1.12–1.18). Malmstedt et
al257 noted a gender-specific effect of diabetes mellitus on
amputation risk, with male diabetic patients at relatively
higher risk than females. Similar or improved amputationfree survival in women is a clinically important observation
given the previously discussed gender differences in age,
comorbidities, and anatomic factors that otherwise might
diminish enthusiasm for revascularization.
Perioperative Adverse Events
Female gender has been identified as a risk factor for
perioperative adverse events. Several studies have reported
higher rates of perioperative wound complications in
women.168,224,241 Belkin et al224 observed a greater frequency
of wound complications (infections, hematomas, and seromas) in women undergoing in situ lower extremity arterial
bypass (13.5% versus 3.3%). Nguyen et al168 also identified
female gender as an independent predictor of wound complications after lower extremity bypass (odds ratio 1.376, 95%
CI 1.09 –1.92) and observed associations with major wound
complications, increased length of hospital stay, and lower
quality of life. Mays and colleagues258 reported a significantly higher incidence of perioperative myocardial infarction in women undergoing infrainguinal vein graft bypasses
(9.8% versus 2%).
Female gender has also been associated with increased risk
for adverse events after endovascular treatment of PAD. In
their analysis of complications associated with percutaneous
lower extremity angioplasty, Matsi et al203 noted a significantly higher incidence of bleeding complications in women
(15% versus 6%).
Quality of Life and Other Outcomes
In their prospective longitudinal study evaluating healthrelated quality of life among patients with intermittent claudication and critical limb ischemia, Wann-Hansson et al213
found that female gender adversely impacted durability of
quality of life after revascularization. These findings differed
from those of Klevsgard et al,200 who did not observe any
association between gender and quality of life assessed with
the same instrument. Nguyen et al281 evaluated predictors of
change in quality of life after lower extremity vein graft
bypass as part of the PREVENT III clinical trial and did not
observe a significant gender effect. In their prospective
evaluation of functional outcomes associated with surgical,
endovascular, and medical treatment of patients with intermittent claudication, Feinglass et al195 did not identify significant gender associations with walking distance, physical
function, ABI, pain, or symptoms.
Lower Extremity Pneumatic Compression
Sequential pneumatic compression has been demonstrated to
increase lower extremity blood flow in patients with PAD.282–288
Women constituted 30% of participants in the studies of
lower extremity pneumatic compression as treatment for
symptomatic PAD that evaluated clinical outcomes and
reported gender.289 –291 These studies each included ⱕ50
patients and did not report any gender-specific analyses.
Summary Statements
1. There is no gender-by-treatment interaction for women
in response to cilostazol.
2. The exercise training literature in PAD demonstrates a
consistent and clinically meaningful response to training programs regardless of gender, although only approximately one fourth of the subjects were women and
very few studies reported gender-specific outcomes.
3. Possible associations between female gender and adverse outcomes associated with PAD revascularization
therapies (both endovascular and surgical) are inconsistent and may be confounded by age, comorbidities, and
anatomic factors.
Awareness and Knowledge of PAD
Among Women
The Evidence Base of Low PAD Awareness
and Knowledge
The public continues to demonstrate a profound lack of
awareness of PAD. “Awareness” is defined as the basic level
of knowledge that a disease exists and/or is present in the
community. Public awareness is a key step in any public
cardiovascular health protective intervention. Without such
awareness, the population at risk is not empowered to know
how to obtain a timely diagnosis, early symptoms are not
reported to clinicians, and informed treatment choices and
adherence to risk reduction therapies cannot be easily
achieved. Women play an important role in population-based
improvements in CVD awareness because they serve a health
prevention and access role in families, select personal and
family healthcare providers, and engage the family unit in
health interventions, as their own health is preserved.12,292
Gender-based differences in public awareness of most
cardiovascular risk factors and diseases have impeded past
CVD preventative efforts.293,294 Until recently, no information has existed to document rates of public awareness
of PAD, which would provide a baseline to evaluate
potential gender-based knowledge gaps or to improve such
awareness and knowledge. The current literature now
includes 3 public awareness surveys that have been published between 2007 and 2009. In Canada and the United
States, 2 identical cross-sectional population-based telephone surveys were conducted between May and July
2006. A PAD cross-sectional survey of specifically 162
women was conducted from December 2004 to March
2006 in the United States by the interdisciplinary Peripheral Artery Disease Coalition. The US survey by Hirsch et
al11 was performed by use of random digit dialing on a
representative sample of 2501 adults ⬎50 years of age,
with an oversampling of 250 blacks and Hispanics, to
measure public awareness of PAD. The survey assessed
demographics and risk factors, as well as knowledge of the
causes and consequences of PAD. The study results
demonstrated an overwhelming lack of awareness of PAD;
3 of 4 adult Americans surveyed have no awareness of
PAD (did not recognize “PAD” or “PVD” [peripheral
vascular disease] as a disease), which was much lower than
for atherosclerosis risk factors or other common CVDs.
Hirsch et al
This low level of PAD awareness was starkly contrasted
with the high awareness of much less common disorders
such as multiple sclerosis, cystic fibrosis, or amyotrophic
lateral sclerosis. Respondent cohorts at highest risk for
PAD (the elderly and minorities) were the least informed.
In addition, among the respondents who were aware of
PAD, half or fewer were aware that smoking (44%) and
diabetes mellitus (50%) could lead to PAD. Media sources
ranked as the most common primary source of information
(broadcast or cable television 26%, magazines 15%, and
newspaper 5%). Very few respondents (19%) had heard
about PAD from healthcare providers. Women were
slightly more aware of PAD and its associated risk factors
than men.
In the Canadian study,295 comparable methods were used
to evaluate a sample of 501 adults who were ⬎50 years old.
This survey provided results strikingly similar to the US
study, with 2 of 3 adult Canadians unaware of PAD. Results
indicated that PAD awareness was lowest in males (31.8%),
adults ⱖ70 years of age (33.3%), and those with lower
education levels (28.6%) and lower income (30.9%).
Younger women (50 – 69 years of age) with greater than high
school education were more aware of risk factors for PAD
than men.
A cross-sectional study by Bush et al296 that focused on
162 women from a Veterans Affairs ambulatory clinic reported that PAD knowledge and awareness were poor among
women at risk for CVD (Table 4). Data were collected by use
of a self-reported questionnaire that focused on symptoms,
perceived risk factors, and patient preferences for knowledge.
Cardiovascular risk was rated with a modified version of the
Framingham risk score. Results demonstrated that this patient
population had many risk factors for PAD, yet had low levels
of PAD knowledge.
Summary Statements
1. Awareness of PAD in women and men is strikingly low
compared with knowledge of other CVDs and general
diseases.
2. Current data suggest that women may be somewhat
more aware of PAD and its risk than their male
counterparts.
3. Improvement or elimination of this “knowledge gap”
would provide a major opportunity to improve the
health of women and of the broader national population.
National Education and Research Programs
Related to PAD and CVD in Women
Current Educational Materials for Patients and
the Public Do Not Specifically Address PAD
in Women
CVD research and education within the federal government
fall primarily within the missions of the National Institutes of
Health (www.nih.gov) and the Centers for Disease Control
and Prevention (CDC; www.cdc.gov). Several agencies
within the National Institutes of Health specifically address
PAD and CVD as part of their public education responsibilities. The NHLBI (www.nhlbi.nih.gov) now oversees a well-
11
developed CVD educational campaign directed toward
women: The Heart Truth (http://www.nhlbi.nih.gov/
educational/hearttruth/). This campaign now focuses only on
coronary disease and stroke, the 2 most commonly recognized CVD syndromes, and their associated morbidity and
mortality; the Heart Truth campaign does not cross-link with
other health education programs, to minimize message dilution. The NHLBI sponsored a 3-year public awareness
campaign on PAD in partnership with the PAD Coalition.
Educational materials developed as part of the campaign can
be found at http://www.nhlbi.nih.gov/health/public/heart/pad/
stay/. PAD also is a topic in the NHLBI’s Diseases and
Conditions Index, a popular Web site accessed frequently by
the public (http://www.nhlbi.nih.gov/health/dci/Diseases/pad/
pad_what.html).
In patient education materials from the National Institute of
Diabetes and Digestive and Kidney Diseases (http://www2.niddk.
nih.gov/), PAD is framed as a complication of diabetes mellitus
(Diabetes, Heart Disease, and Stroke; http://diabetes.niddk.nih.
gov/dm/pubs/stroke/DM_Heart_Stroke.pdf). The approach to
PAD in these materials is fairly general and does not
currently address issues specifically for women. The National
Institute on Aging (www.nia.nih.gov) has an excellent patient
education booklet on vascular disease in the elderly, which presents
PAD as a disease of aging in both men and women (Aging Hearts
and Arteries: A Scientific Quest; http://www.nia.nih.gov/health/
publication/aging-hearts-and-arteries-scientific-quest/chapter-4blood-vessels-and-aging-rest). The National Institute on Aging, in
partnership with the National Library of Medicine, recently added
PAD to the topics on its Web site NIHSenior Health.gov
(http://nihseniorhealth.gov/peripheralarterialdisease/toc.html).
The CDC’s Division for Heart Disease and Stroke Prevention focuses on preventing and controlling risk factors for all
CVD, including PAD. CDC has a PAD fact sheet that is
available on its Web site at http://www.cdc.gov/dhdsp/data_
statistics/fact_sheets/fs_pad.htm. The site presents information on prevalence, risk factors, signs and symptoms, diagnosis, treatment, and prevention of PAD. A CDC state-level
education campaign for low-income women (“WiseWoman”)
focuses on heart disease and stroke but does not mention
PAD (http://www.cdc.gov/wisewoman/index.htm).
Several broadly framed CVD planning documents, such as
the national Heart Disease and Stroke Prevention Program
(http://www.cdc.gov/dhdsp/) and the Public Health Action
Plan to Prevent Heart Disease and Stroke (http://www.cdc.
gov/dhdsp/action_plan/index.htm) mention PAD, but only as
a risk factor for heart disease and stroke, not as a specific
CVD with its own symptoms, clinical presentations, diagnostic pathways, and disease-specific treatments. The CDC’s
National Heart Disease and Stroke Prevention Program is
focused on the ABCS of heart disease and stroke prevention,
including appropriate aspirin therapy, blood pressure control
(including sodium reduction), cholesterol control, and smoking cessation, and this focus has the potential to prevent or
modify the outcomes of PAD. The “Million Hearts” initiative, launched in September 2011, co-led by the CDC and the
Centers for Medicare & Medicaid Services in partnership
with the American Heart Association and other organizations,
brings together programs and policies to promote the ABCS
12
Circulation
Table 4.
March 20, 2012
Public PAD Awareness Surveys and Gender-Based PAD Knowledge
Hirsch et al11 (2007)
Representative Sampling;
Telephone Survey, Self-Report
Sampling Method
Lovell et al295 (2009)
Representative Sampling;
Telephone Survey,
Self-Report
Bush et al296 (2008)
Convenience Sampling; Interview,
Medical Record Review,
Screening
Sample characteristics
Sample size, n
2501
501
162
Age range, y
ⱖ50
ⱖ50
40–85
Males (n⫽1163)
Females
(n⫽1338)
Males (n⫽233)
Females (n⫽268)
46.5
53.5
46.4
53.6
Diabetes mellitus
18.9
18.2
13.3
10.8
19.7
Hypertension
53.0
52.3
34.8
50.9
47
Dyslipidemia
48.5
47.5
38.8
34.9
58.9
Ever smoking
58.4
41.1
69.1
49.6
23
Gender, %
Females
100
Medical history, %
“Cardiac disease”
NA
Past myocardial infarction
11.5
Past stroke or carotid disease
NA
5.1
Family history of cardiac disease
8.6
4.7
NA
5.2
NA
5.6
NA
62.2
PAD awareness data
Awareness of PAD, %
23.0
28.3
31.8
38.8
Perceived Risk for Self Among Those
Who Have The Risk Factor
Perceived Causes Among Those Familiar With PAD
Males (n⫽517) Females (n⫽722)
Males (n⫽74)
58.5 (Enriched sampling methods)
Females (n⫽104)
Perceived PAD causal risk factors (%)
Diabetes mellitus
50.9
49.3
45.9
53.8
65.5
Hypertension
46.7
47.6
45.9
54.8
54.9
Dyslipidemia
46.7
47.2
45.2
51.0
53.4
Smoking
54.0
56.8
52.7
62.5
58.3
Cardiac disease
41.6
44.2
37.8
48.1
50.6
Family history
37.0
37.8
25.7
44.2
53.8
Perceived Consequences Among Those Familiar With PAD
Perceived consequences of PAD, %
Stroke
26.1
28.6
17.6
24.0
Death
22.6
27.3
23.0
19.2
Heart attack
14.4
14.3
15.1
23.1
Amputation
14.6
12.9
14.9
10.6
PAD indicates peripheral artery disease; NA, not available.
approach through improved clinical care and promotion of
healthier lifestyles and communities. This improvement to
our nation’s cardiovascular health prevention portfolio will
also support improvements in PAD outcomes.
The CDC’s Division of Diabetes Translation (http://www.
cdc.gov/diabetes/) addresses PAD in its public education
materials on complications of diabetes mellitus. The Web
site provides a diagram of the effect of diabetes mellitus on
the female body, including circulatory problems in the
feet and risk of amputation; however, the diagram does not
use the specific term “peripheral artery disease” (“Effects
of Diabetes on a Female”; http://www.cdc.gov/diabetes/
consumer/problems_humanbody_female.htm). In addition,
in 2005, the Division of Diabetes Translation in collabo-
Hirsch et al
ration with the CDC’s National Center for Health Statistics
published an article on lower extremity PAD that highlighted the
importance of PAD in patients with and without diabetes
mellitus. This report can be found in the CDC journal
Morbidity and Mortality Weekly Report at http://www.cdc.
gov/mmwr/preview/mmwrhtml/mm5445a4.htm.
Guidelines for Health Professionals Do Not
Specifically Address PAD in Women
The National Cholesterol Education Program–Adult Treatment Panel III, the federal government entity that issues
cholesterol treatment guidelines, defines the presence of PAD
as a CHD risk equivalent, which supports similar goals of
treatment in individuals with PAD as with CAD itself.297
(Note: Updated guidelines are anticipated to be released in
early 2012; http://www.nhlbi.nih.gov/guidelines/cvd_adult/
background.htm). The American Heart Association guideline
on CVD prevention specifically in women is consistent with
Adult Treatment Panel III in identifying women with PAD as
having a CHD risk equivalent.298 In terms of diagnostic
approaches to identifying individuals with PAD, Adult Treatment Panel III states that measurement of ABI is “a simple,
noninvasive test to confirm the clinical suspicion of lower
extremity PAD,” and it states further that ABI “can be
considered a diagnostic test to identify persons at high risk for
CHD.”297 These guidelines do not, however, comment on the
use of ABI for screening specifically, nor do they make any
gender-specific recommendations differentiating an approach
for women specifically. The 2004 update of Adult Treatment
Panel III makes no further mention of PAD in women.299
Similarly, the current American Heart Association guidelines
for women make no mention of the use of ABI or other
approaches to screen women for PAD.298 Such guideline
updates increasingly recognize the ABI evidence base of efficacy for both women and men. As such, the “2010 ACCF/AHA
Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults” assigns a class IIa recommendation for use of the
ABI in asymptomatic adults at intermediate risk to achieve the
benefit of risk reassignment and PAD diagnosis.300
There Is a Paucity of Research on PAD in Women
The National Institutes of Health has a relatively
small portfolio of funded research projects on PAD (http://
projectreporter.nih.gov/reporter.cfm). The research covers
the scientific spectrum from basic and mechanistic research
to clinical, translational, and population science. The primary
institutes supporting PAD research are the NHLBI, the
National Institute of Diabetes and Digestive and Kidney
Diseases, and the National Institute on Aging. The National
Institutes of Health Office of Research on Women’s Health
(http://orwh.od.nih.gov/) has maintained an interest in PAD
and has cofunded several projects to increase enrollment of
female participants or conduct gender-specific data analyses;
however, virtually none of the projects are focused on women
specifically or on gender differences. Many of the clinical and
population science projects studying PAD barely manage to
recruit their target numbers for female participants.
Public health–level data resources with information on
demographic subgroups can be a great stimulus to research.
13
These resources can include surveys, maps, and registries.
The 1999 to 2004 National Health and Nutrition Examination
Survey (NHANES), which was conducted by the CDC’s
National Center for Health Statistics, included specific questions about PAD and provided gender-specific data. Mapping
approaches such as the PAD Atlas (http://www.mappad.org/
mappad/) are also valuable launching tools for researchers.
Summary Statements
1. PAD is addressed in government-sponsored education
programs and activities; however, it is not currently
positioned as a distinct topic in women’s cardiovascular
health programs.
2. Increased cross-communication between women’s heart
health programs and PAD awareness programs could
create a more unified and compelling risk reduction
message and help identify women with symptomatic
PAD so that treatments would be initiated. When
possible, the information provided should reinforce that
PAD is a distinct disease, not simply a “risk factor” for
other CVDs.
Recommendations for Future Action and
Research: A “Call to Action” for Women
Women carry a large health burden from PAD in the United
States and all nations. A concerted effort, in clinical research,
clinical care, and health policy, could provide opportunities to
lower this burden, with benefits to women and to the
community as a whole. Specific opportunities to improve the
health of women with or at risk for PAD include but are not
limited to the following: (1) Improvements in basic vascular
biology and population-based research of PAD; (2) improvements in data collection methods to better evaluate genderspecific outcomes of diagnostic and therapeutic clinical investigations; and (3) improvements in translation of current PAD
knowledge to women in clinical practice. These opportunities
are detailed below, with evidence provided in each topic area
above, as well as from current PAD guideline documents.13,14
Vascular Biology and Population-Based PAD
Research Opportunities
The current evidence base has long demonstrated that women
develop atherosclerotic arterial disease later in life, with
differing anatomic presentations of stenotic and aneurysmal
disease (in the aorta, first-order branches, and the lower
extremity arteries) and with differing age-dependent thrombotic event rates. Nevertheless, the vascular biological underpinnings of these differences are not well defined. Additionally, the evidence base to describe the population-based
gender-specific PAD incidence and prevalence remains incomplete. Clinical populations are not adequate to provide
such estimates, and national PAD disease burdens can only be
defined from surveillance of the full population at risk.
Recommendations
1. The potential impact of gender on the vascular
biology of atherosclerosis, aneurysmal disease, and
thrombosis remains an area in which new basic
research contributions should be evaluated.
14
Circulation
March 20, 2012
2. Future studies of PAD prevalence and risk should
(a) clearly define the methods by which PAD was
ascertained; (b) include gender-specific, and preferably age-specific, prevalence values; (c) evaluate
the possibility of study-specific selection bias; and
(d) explicitly state how the ankle and arm blood
pressure measurements for the ABI were obtained
and how the ABI was calculated.
Data Collection Methods to Better Define
Gender-Specific Outcomes of Diagnostic and
Therapeutic Clinical Investigations (Benefit
and Harm)
Diagnosis
The current evidence base has not evaluated diagnostic
physiological or advanced imaging techniques to determine
whether the anthropomorphic and arterial diameter differences in women and men are associated with differences in
test accuracy.
Recommendation
3. Future PAD diagnostic tool investigations should
include adequate gender-based samples to prospectively evaluate the sensitivity, specificity, and accuracy of each test for women and men.
Treatment
Although the major expansion of knowledge regarding PAD
treatment has provided clear benefit to both men and women,
past investigation has been characterized by low rates of
enrollment of women and minorities.63,224,244,245,277 Thus,
most studies have been underpowered to detect gender-based
differences in primary outcome efficacy end points or rates of
treatment-related adverse events.
Recommendations
4. Clinical trials assessing the efficacy of pharmacological, exercise, and revascularization therapies to
improve symptomatic PAD should recruit and enroll female participants at a rate that reflects the
population prevalence of women in the symptomatic population.
5. Pooled analyses of currently available data from
supervised exercise studies could help overcome
limitations of small sample sizes seen in many
current clinical trials and provide sufficient statistical power to conduct gender-specific analyses.
6. In addition to primary study end points, analyses
related to lower extremity revascularization for
PAD should consider demographic and comorbidity factors, procedure-related complications, and
procedural utilization as potential outcomes for
gender-specific reporting.
7. Gender should not be used as a primary selection
factor for revascularization therapy in patients
with PAD. Anatomic, demographic, and comorbidity factors often differ on the basis of gender,
potentially influence revascularization outcomes,
and should be incorporated into clinical decision
making.
Translation of Current PAD Knowledge to
Women in Clinical Practice
For any disease to be prevented, detected, and treated, both
the public and clinicians must have access to state-of-the-art
knowledge. Despite advances in population-based knowledge
of PAD risk (high-prevalence target populations can be easily
identified to detect PAD in its asymptomatic latent phase),
populations “at high risk” include both men and women. Yet
the creation and dissemination of gender-specific messages
has not yet been widely used as a tool applied to the PAD
pandemic.1,2,11,12,13,23,30
Recommendations
8. Primary care providers, including gynecologists,
should identify women with or at high risk for PAD
by targeted use of the ABI test per current national
guidelines.
9. Women at risk for PAD should be informed of
common PAD risk factors, symptoms, and cardiovascular risk by all health professionals.
10. Women’s cardiovascular health (“heart health”)
programs should include both PAD awareness
campaigns and gender-relevant PAD care pathways designed to lower cardiovascular risk, prevent or decrease limb ischemic symptoms, and
minimize amputation risk.
11. Women with or at risk for PAD should undergo an
ABI or alternative diagnostic assessment for PAD
(Table 1, ACC/AHA Guidelines for the Management of PAD).
Acknowledgments
The authors wish to acknowledge the contributions of the following
individuals who provided significant help in consolidating the work
of the writing committee: Michael Mussolino and Paul Sorlie, of the
National Heart, Lung, and Blood Institute, for providing the data
access and analysis that created Table 2 of this statement; and Donna
Stephens, Barb Lux, Judy Bezanson, Dwight Randle, and Nereida
Parks for support of writing committee work.
Hirsch et al
15
Disclosures
Writing Group Disclosures
Writing Group
Member
Other
Research
Support
Speakers’
Bureau/
Honoraria
Expert Witness
Ownership
Interest
Consultant/
Advisory Board
Other
Employment
Research Grant
University of
Minnesota
Abbott Vascular†;
Bristol-Myers
Squibb/Sanofi-Aventis†;
NHLBI†
None
None
None
None
None
None
Matthew A.
Allison
UCSD
None
None
None
None
None
None
None
Antoinette S.
Gomes
UCLA Medical Center
None
None
None
None
None
None
None
Matthew A.
Corriere
Emory/Atlanta VA
Medical Center
None
None
None
None
None
None
None
Sue Duval
University of
Minnesota
None
None
None
None
None
None
None
NHLBI
None
None
None
None
Johnson &
Johnson†
None
None
William R.
Hiatt
University of
Colorado School of
Medicine and CPC
Clinical Research
Aastrom†; AstraZeneca†;
GlaxoSmithKline†;
MEDRAD Possis†;
Sanofi-Aventis†;
Vermillion†
None
None
None
None
None
None
Richard H.
Karas
Tufts Medical Center
None
None
None
None
None
None
None
Marge B.
Lovell
London Health
Sciences Centre
None
None
Bristol-Myers
Squibb/
SanofiAventis*
None
None
None
None
Mary M.
McDermott
Northwestern
University
NIH/NHLBI†
Foundation for
Informed
Decision
Making*
None
None
None
Eli Lilly*
Contributing
editor for
JAMA†
Donna M.
Mendes
St. Luke’s–Roosevelt
Hospital Center
None
None
None
Spivak v LoGerfo, Plaintiff, 2008, nerve
damage after resection of
Schwanomma*; Johnson v Johns
Hopkins, Defendant, 2008, amputation
after balloon pump placement due to
MI*; Coleman v Smirnov, defendant,
2008, inadequate treatment after the
late diagnosis of an infected aortic
bifemoral graft*; Reviewed a case as
part of the Vascular Surgery
Committee for the American College of
Surgeons, re: compactment*
None
None
None
Nancy A.
Nussmeier
SUNY Upstate
Medical University
ConMed*; Nonin*
None
None
None
None
Merck (formerly
known as
Schering
Plough)*; Novo
Nordisk*
None
Diane
TreatJacobson
University of
Minnesota School of
Nursing
NIH/NHLBI†
None
Bristol-Myers
Squibb/
Sanofi
Partnership*
None
None
None
None
Alan T. Hirsch
Abby G.
Ershow
This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the
Disclosure Questionnaire, which all members of the writing group are required to complete and submit. A relationship is considered to be “significant” if (1) the person
receives $10 000 or more during any 12-month period, or 5% or more of the person’s gross income; or (2) the person owns 5% or more of the voting stock or share
of the entity, or owns $10 000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the
preceding definition.
*Modest.
†Significant.
16
Circulation
March 20, 2012
Reviewer Disclosures
Research
Grant
Other
Research
Support
Speakers’
Bureau/
Honoraria
Expert
Witness
Ownership
Interest
Consultant/
Advisory
Board
Other
Reviewer
Employment
Lisa Begg
NIH/Department of Health
and Human Services
None
None
None
None
None
None
None
Eileen Collins
University of Illinois at
Chicago
NIH grant in
data
analysis†
None
None
None
None
None
None
Anne Roberts
UC San Diego
None
None
None
None
None
None
None
This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure
Questionnaire, which all reviewers are required to complete and submit. A relationship is considered to be “significant” if (1) the person receives $10 000 or more
during any 12-month period, or 5% or more of the person’s gross income; or (2) the person owns 5% or more of the voting stock or share of the entity, or owns
$10 000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
†Significant.
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KEY WORDS: AHA Scientific Statements 䡲 arteriosclerosis
䡲 myocardial infarction 䡲 peripheral artery disease
䡲 stroke 䡲 women
䡲 epidemiology
䡲 prevention

M. McDermott, Donna M. Mendes, Nancy A. Nussmeier and Diane

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