Sample Collection Procedure VerifyNow Aspirin or P2Y12

1
5into
ml
Sample collection directly
vacuum collection tubes
1
1. Use 2 mL Greiner Bio-One partial-fill vacuette tubes with
3.2% sodium citrate (blue top). Greiner #454322.
1
2
2. Collect 2 tubes of whole blood using a 21 gauge or larger
needle. First, collect a discard tube (at least 2 mL) making
sure the discard tube does not contain any platelet
1
3
inhibiting substance
(e.g. EDTA). Butterfly (21 gauge) is
OK to use.
2
CBC
2
3
4
2
X5
5
6. Label the tube with the patient ID, date and time it was
drawn. Do not refrigerate.
Indwelling Catheter
5 ml
1. Discard the first 5 mL from an indwelling catheter to clear
the line. Ensure the catheter is free of clots.
2. Immediately transfer blood to a 2 mL Greiner Bio-One
partial-fill vacuette tube with 3.2% sodium citrate (blue
top). Greiner #454322. Fill to the black line (1/2 tube). Do
not under fill.
3
1
CBC
2
Prasugrel
(Effient®)
4. If drawing blood for a CBC at the same time, fill the CBC
5
tube last
5. Gently invert the tube at least 5 times to ensure complete
mixing of the contents. Samples with evidence of clotting
should not be used.
6
1
Ticlopidine
(Ticlid®)
P2Y12
3. Fill the second tube (sample
tube) to the black line (1/2
X5
4
tube). Do not under
fill. Discard the first tube. Keep the
second tube for testing.
CBC
2
Clopidogrel
(Plavix®)
Aspirin
Aspirin
75 mg
7 days on maintenance1
300 mg
8 hours post bolus2
600 mg
6 hours post bolus3
250 mg
2 hours post does4
250 mg (bid)
21 days (steady state)4
5 mg
5 days on maintenance5
10 mg
5 days on maintenance5
60 mg
45 minutes post bolus
81 - 325 mg
2 hours post dose
5
X5
Run Time
(Minutes)
System
10
~3
30
~5
Common error codes related to Attention 24 or 28 •
•
•
•
Platelet count less than 119,000
HCT < 33%
Recent IIb/IIIa drug use
Improper sample collection
For more details, see the VerifyNow Test package insert.
1 Plavix (clopidogrel bisulfate) tablets Prescribing Information. Bristol-Myers Squibb/Sanofi
Pharmaceuticals Partnership. 3/2010 Update. 2 Price, MJ et al. Am J Cardiol 2006;98:681-684.
3 Hochholzer W. et al. Circulation. 2005;111:2560-2564. 4 Ticlid (ticlopidine hydrochloride) tablets
Prescribing Information. Roche Laboratories Inc. Revised 12/2005. 5 Effient (prasugrel) tablets
Prescribing Information. Daiichi Sankyo, Inc. and Eli Lilly and Company. July 10, 2009. 6 VerifyNow IIb/
IIIa Test Package Insert. 14320.K. 2009-06-10.
3. If drawing blood for a CBC at the same time, fill the CBC
tube last
4
Sample
Incubation
(Minutes)
Suggested
Test Timing
Dose Given
Direct Venipuncture
Medication(s)
Tested
Sample Collection Procedure
VerifyNow
Test
VerifyNow Aspirin or P2Y12
3985 Sorrento Valley Boulevard
San Diego, California USA 92121
Toll Free: 800.643.1640
support@accumetrics.com
4. Gently invert the tube at least 5 times to ensure complete
mixing of the contents. Samples with evidence of clotting
should not be used.
www.accumetrics.com
5. Label the tube with the patient ID, date and time it was
drawn. Do not refrigerate.
The Accumetrics logo and VerifyNow are registered trademarks of
Accumetrics, Inc., ©2012 Accumetrics, Inc.
PN:148039.D
3/30/12
6 Month Outcomes After Drug Eluting Stent Implantation
12
13
Responders (n=699)
10.5
P2Y12 Inhibitors
Plavix® (clopidogrel)
Effient® (prasugrel)
Ticagrelor® (Brilinta)
8.6
ADP (P2Y12)
Epinephrine
2.7 Factor
Platelet Activating
2.3
1.4
Cardiac Death
p< 0.001
Stent Thrombosis
p< 0.001
AA
Cardiac Death & ST
p< 0.001
Aspirin
Non-responders defined as >70%
aggregation by LTA 12 hours
TXA
Thromboxane A
after 600-mg clopidogrel plavix load
2
Thrombin Receptors
GP IIb/IIIa Inhibitors
ReoPro® (abciximab)
Integrilin® (eptifibatide)
Post -PCI
30 d
6 mo
N=1109 N=1012 N=944
Post -PCI
VerifyNow Aspirin Test:
Platelet response to2.8P2Y12 inhibitors (e.g clopidogrel (Plavix),
2.8
prasugrel (Effient) and ticlopidine (Ticlid).
Platelet response to aspirin
1.6
0.0
• ADP induced
aggregation
- extent
CV Death
non-fatal
MI of platelet
ST
aggregation
in the presence
of P2Y12 inhibitors
p=0.04
p=0.6
p=0.004
6 mo
ARU
(Aspirin Reaction
Units)
pharmacodynamic
responses
to study drug.
1.0
• Arachidonic
aggregation
Patients
with low acid
levelsinduced
of OTR after
PCI appeared to have few (if any) CV e
• Reference range: 620-672 ARU (pre-drug administration)
Price MJ, AHA 2010
CV Death/MI/ST
• Measurement range: 350–700 ARU
p=0.008
• Residual
Platelet Reactivity
(RPR)
ADP
P2Y12
receptor
Non-responders
defined as
>235 of
PRU
(upper
tertile)
on VerifyNow
2
30 d
In patients with high on-treatment reactivity (OTR) after PCI, there was subs
1.9
PRU (P2Y12 Reaction Units)
1.3
Result Interpretation:
• Recommended cut-off: 550 ARU
GP IIb-IIIa
Example PRU’s
As measured by aggregometry
350
Fibrinogen
GP IIb-IIIa
30
Blood Sample
Showing Inhibition of
Platelet Function
20
Blood Sample
Showing Normal
Platelet Function
Agonist
High
Residual Platelet Reactivity
250
200
150
100
Red Blood Cells
50
Fibrinogen-Coated Beads
Platelet-Bead
Aggregates
Platelets
1st
(0-8%)
300
ASA Resistant
ASA Sensitive
PRU Range
Incidence of early failure
To Order this Test:
N=1105 N=1013 N=940
VerifyNow P2Y12 Test:
Importance of Aspirin Response to Graft Patency
10
6.5 0
0.9 reference range 1.0
• Post-drug
of 18-435
0.0
Collagen
Shear Forces
To Order this Test:
2nd
Low Light
(9-20%)
Transmittance
3rd
(21-57%)
4th
Increased
Light
(58-100%)
Transmittance
Poston et al. J Thorac Cardiovasc Surg 2006;131:122-30
Low
Residual Platelet Reactivity
Aspirin Reaction Units (ARU)
% of Patients
3.5
3.1
VerifyNow Aspirin Results
Non-Responders (n=108)
4.6
Plasmin
2.4
Responders (n=209)
8.6
ADP (P2Y1)
Serotonin
Overall (n=317)
Non-Responders (n =105)
% of Patients
Overall (n=804)
100
VerifyNow
P2Y12 Results
VerifyNow
Activates Specific
Drug Receptor
Light Transmittance
AggregometrySites
40
reactivity @ 30
days: 62%
vs 40%,
p<0.001
Findings comparable regardless of test method.
How It Works:
700
650
Non-Therapeutic Range
600
550
500
450
Therapeutic Range
400
350
Post Aspirin Ingestion