System

Interpreting ResultsAspirin Test

Up to 1/3 of patients on antiplatelet medications may not receive the expected platelet inhibiting effect.1

Patients with inadequate response to their antiplatelet medications may be at significantly greater risk of myocardial infarction, stent thrombosis and death.2-5

The VerifyNow Aspirin Test is a whole blood assay to aid in the detection of platelet inhibition due to aspirin therapy.

What is Reported?The lab report may look similar to the following:

Aspirin Reaction Units (ARU) indicate the amount of thromboxane A2-mediated activation of GP IIb/IIIa receptors involved in platelet aggregation. ARU is calculated as a function of the rate and extent of platelet aggregation. Expected values are in the range of 350-700 ARU. The cut-off to determine if a patient is receiving the therapeutic benefit of aspirin is 550.

***************************************************************************Result Name Result Units Reference Platelet Response ASPIRIN 400 ARU See Below (1)

(1) Test results are reported in Aspirin Reaction Units (ARU). 350 - 549 ARU – therapeutic range for platelet function. 550 - 700 ARU – NON- therapeutic range for platelet function.

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The VerifyNow Aspirin Test results should be interpreted in conjuction with other clinical and laboratory data available to the clinician. Integrilin is a registered trademark of Milennium Pharmaceuticals. Reopro is a registered trademark of Centocor, Inc. Plavix is a registered trademark of Sanofi-Synthelabo, Inc.

3985 Sorrento Valley BoulevardSan Diego, California USA 92121Toll Free: 800.643.1640

www.accumetrics.com

3985 Sorrento Valley BoulevardSan Diego, California USA 92121Toll Free: 800.643.1640

www.accumetrics.com

The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. © 2013 Accumetrics, Inc. All Rights Reserved. PN: 14341.D 01/2013

Therapeutic Response

ARU values less than 550 are consistent with a patient who is receiving the therapeutic benefit of aspirin.

Pre-Surgical Screen

Prior to surgery, the VerifyNow Aspirin Test can aid in guiding clinical decisions whether to discontinue aspirin therapy or to remain on aspirin to improve graft patency.6 Medical research suggests that there is patient variability in response to aspirin.7 Values less than 550 ARU are reported if the patient is receiving the therapeutic benefit of aspirin. After aspirin discontinuation, ARUs less than 550 indicate platelets remain inhibited by aspirin.

In patients with high on-treatment reactivity (OTR) after PCI, there was substantial variability over time in the pharmacodynamic responses to study drug.Patients with low levels of OTR after PCI appeared to have few (if any) CV events.

Price MJ, AHA 2010

ADAPT-DES: Relationship Between VerifyNow P2Y12 PRU and Stent Thrombosis within 30 Days Definite or probable stent thrombosis

DE

FIN

ITE

/PR

OB

AB

LE S

T (

%)

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

2.0

0 5 10 15 20 25 30

0.81%

0.21%

P2Y12 PRU > 208 (n=3607)

P2Y12 PRU ≤ 208 (n=4834)

P <0.001

HR [95% CI]=

3.89 [1.90, 7.98]

DAYS

3607 3540 3534 34824834 4754 4752 4686

Number at risk>208 PRU≤208 PRU

500

400

300

200

100

0

PRU VALUE

Post -PCI 30 d 6 mo Post -PCI 30 d 6 mo

N=1013 N=940N=1105 N=1012 N=944N=1109

P = 0.98P < 0.001

PERSISTENTLY HIGH REACTIVITY @ 30 DAYS: 62% VS40%, P<0.001

500

400

300

200

100

0

PRU 12 -24 HRS POST-PCI

High ResidualReactivity

Not HighResidual Reactivity

N=1105 N= 586

Red dots: patients with CV death, MI, or ST

230 PRU

Brar, S et al J Am Coll Cardiol. 2011 Nov 1;58(19):1945-54.*There are currently no definitive criteria that establish a standard PRU/% inhibition cutoff for ischemic risk

N = 3049

DE

AT

H, M

I, O

R S

T

TIME (DAYS)

N=30490.20

0.15

0.10

0.05

0.000 100 200 300 400 500 600 700

Q4 15.8% <0.001

Q3 10.9% 0.02

Q2 6.9% 0.97Q1 5.8% -

EventRateQuartile P-value*

CV Events and Post-PCI PRU In Patients With High and Not High Reactivity Treated With Clopidogrel 75-mg Daily

PharmacodynamicsEffect of SD vs HD Clopidogrel

Standard-Dose High-Dose

VerifyNow Meta AnalysisSurvival Analysis of PRU Quartiles*

Stone GW, et al presented at TCT 2011

Chart Tertiary Title or Labels

NON-THERAPEUTIC RANGE

THERAPEUTIC RANGE

POST ASPIRIN INGESTION

ARU: A

SPIR

IN R

EA

CT

ION

UN

ITS

700

650

600

550

500

450

400

350

NON-THERAPEUTIC RANGE

THERAPEUTIC RANGE

POST ASPIRIN INGESTION

ARU: A

SPIR

IN R

EA

CT

ION

UN

ITS

700

650

600

550

500

450

400

350

350

300

250

200

150

100

50

PRU: P

2Y

12 R

EA

CT

ION

UN

ITS

Example PRU’s

Conditions That May Affect Test Results• May not report a result if patient has

been exposed to GP IIb/IIIa inhibitors within:

– 48 hours of eptifibitide – 10 days of abciximab

• Improper sample collection (platelet activation)

• Hematologic related issues: Hct, Platelet Count

For more details, see the VerifyNow Test package insert.1 Dupont, AG. et al. Thromb Res 2009 May;124(1):6-13. 2 Patti, G. et al. J Am Coll Cardiol 2008;52:1128-33. 3 Marcucci, R. et al. Circulation 2009;119(2):237-42. 4 Cuissett, T. et al. Am J Cardiol 2008 Jun 15;101(12):1700-3. 5 Price, MJ. et al. Eur Heart J 2008 Apr;29(8):992-1000. 6 Eagle, et. al. ACC/AHA 2004. Guideline Update for Coronary Artery Bypass Graft Surgery. 7 Gum, et. al. Profile and Prevalence of Aspirin Resistance in Patients with Cardiovascular Disease. J Am Coll Cardiol 2001;88:230-235.