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Copyright © 2008 National University Health System Is Platelet Reactivity Testing in Acute Coronary Syndromes Really Relevant?. Chan, MBBS, MHS, MRCP, FACC National University Heart Cen

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Copyright © 2008 National University Health System

Is Platelet Reactivity Testing in Acute

Coronary Syndromes Really Relevant?

Mark Y Chan, MBBS, MHS, MRCP, FACC National University Heart Centre, Singapore

Yong Loo-Lin School of Medicine Singapore

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I have the following potential conflicts of

interest to report:

Research contracts – Roche

Diagnostics, Eli Lilly

Consulting –Eli Lilly, Bayer

Healthcare, Astra-Zeneca

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Copyright © 2008 National University Health System

VerifyNow ®

• Least

operator-dependent

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Conventional Arm :Prasugrel 5 mg

Group 1

No monitoring

Monitoring Arm :Prasugrel 5 mg

1 st assessment : Verifynow P2Y12: 2 weeks ± 2 d

Group 2

ANTARCTIC design

ANTARCTIC a study by the ACTION Group

PRU≥208

Prasugrel 10 mg/day Prasugrel 5 mg Clopidogrel 75 mg/day

Primary end point (net clinical benefit) over 12 months:: Bleeding type 2,3,5 of the BARC

definition andMACE (CV death, MI, urgent revascularisation, stent thrombosis, stroke)

PRU ≤85

2 nd assessment and adjustment:

Verifynow P2Y12: 2 weeks ± 2 d

85<PRU<208

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Primary Endpoint

ANTARCTIC a study by the ACTION Group

CV death, MI, stroke, stent thrombosis, urgent

revascularization or

BARC 2, 3 or 5

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Copyright © 2008 National University Health System

Ischemic Endpoint

CV death, MI, stroke, stent

thrombosis, urgent revascularization BARC 2,3,5

Bleeding Endpoint

ANTARCTIC a study by the ACTION Group

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Multiplate®

Whole blood Impedance Aggregometry

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Copyright © 2008 National University Health System

High On-Treatment Platelet Reactivity to Adenosine Diphosphate

Predicts Ischemic Events

Bonello et al., J Am Coll Cardiol 2010 Sep 14;56(12):919-33

Studies are summarized that link high platelet reactivity (“clopidogrel resistance”) to ischemic events (e.g stent thrombosis)

Best predictivity was found for the Multiplate® analyzer (ADPtest) The consensus cut-off for ADPtest on the Multiplate® analyzer is defined as an aggregation

> 46 U (468 AU*min)

Odds ratio (OR) of 12.0 for Multiplate® vs OR of 1.2 – 5.8 in other methods (odds ratio = how much higher is the risk for the patient to suffer an ischaemic event if

having a “clopidogrel resistance”)

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Copyright © 2008 National University Health System

SMART-ACS

Dual Platelet Reactivity in Acute Coronary Syndrome

Leonardo P de Carvalho 1,2 , MD, PhD; Alan Fong 3 , MBBS; Richard Troughton 4 , MD, PhD, Bryan P., Yan 5 , MBBS; Chee-Tang Chin 6 , MBBS, Sock-Cheng, Poh 1 , Melissa Mejin 3 , Nancy Kwan 5 , Chi-Hang, Lee 1, 7 , MBBS; Adrian F Low 1, 7 , MBBS; Huay-Cheem, Tan 1, 7 , MBBS, MHS; Siew-Pang, Chan 1, 7 ,

Christopher Frampton 4 , A Mark Richards 1,4, 7 , MD, PhD; and Mark Y Chan 1, 7 MBBS, MHS

1 National University Heart Centre, Cardiac Department, Singapore, Singapore 2 Albert Einstein Hospital, Cardiac Department, Sao Paolo, Brazil 3 Sarawak General Hospital Heart Centre, Cardiac Department, Kuching, Malaysia 4 University of Otago, Cardiac Department, Christchurch,

New Zealand 5 The Chinese University of Hong Kong, Cardiac Department, Shatin, Hong Kong 6 National Heart Centre, Cardiac Department, Singapore, Singapore 7 Yong Loo Lin School of Medicine, Medicine Department, National University of Singapore, Singapore

METHODS

RESULTS Table 1: Baseline characteristics

Fig 4: Difference in Initial Versus Final ASPR and ADPR with Different ADP Receptor Antagonists

Fig 2: Percentage of Patients with High PR on Initial and Final ASPR and ADPR Categorized by ACS Diagnosis and PCI Status

Fig 3: Incidence of IPTE, 30-day MACCE and 12-month MACCE As a Function of High Initial ASPR and ADPR Status

Table 2: Logistic Regression Model for IPTE, 30-Day MACCE and 12-month MACCE Relationship between D2B time and

• PR testing has prognostic value when performed before PCI (initial test)

in patients with ACS, but not after PCI (final test);

• High on-treatment PR is mores closely related to early peri-PCI events than late post-PCI outcomes

• ASPR and ADPR improve significantly during the index hospitalization, regardless of whether PCI was performed or whether low or high

potency ADP receptor antagonists were administered

• Both ADPR and ASPR are related to IPTE but unexpectedly, high ASPR had a stronger association with IPTE than ADPR when both tests were included in the same multivariable model

CONCLUSIONS

ACS subjects

Baseline Characteristics:

Men (n, %) 633 (81.6)* 135 (88.8)* 0.03 435 (83.5) 333 (81.8) 0.5

Body-mass index (kg m-2) 26±4 27±6 0.03 26±4 26±5 0.3

Hypertension 517 (66.6%) 91 (60.0%) 0.10 354 (67.9%)* 254 (62.4%)* 0.08

Dyslipidemia 476 (61.3%)* 70 (46.1%)* <0.001 323 (62.0%)* 254 (62.4%)* 0.03

Current Smoker 422 (54.4%) 82 (53.9%) 0.4 287 (55.1%) 230 (56.5%) 0.7

Diabetes 280 (36.1%)* 51 (33.6%)* 0.5 182 (34.9%) 149 (36.6%) 0.5

Prior congestive heart failure 26 (3.4%) 6 (3.9%) 0.7 17 (3.3%) 15 (3.7%) 0.7

Prior myocardial infarction 227 (30.0%)* 28 (18.4%)* 0.007 149 (28.6%) 105 (25.8%) 0.3

Prior stroke 422 (54.4%) 82 (53.9%) 0.7 20 (3.8%) 22 (5.4%) 0.2

Prior CABG 46 (5.9%) 10 (6.6%) 0.7 30 (5.8%) 26 (6.4%) 0.2

Prior PCI 172 (22.2%) 24 (15.8%) 0.08 114 (21.9%) 82 (20.1%) 0.03

Prior stroke 422 (54.4%) 82 (53.9%) 0.7 20 (3.8%) 22 (5.4%) 0.2

GRACE Score (Mean±SD) 98±29 103±26 0.13 98±28 100±30 0.1

Prior aspirin treatment (>7 days before admission) 266 (34.3%) 40 (26.3%) 0.05 171 (32.8%) 135 (33.2%) 0.8

Prior ADP receptor antagonist treatment 76 (9.8%) 19 (12.5%) 0.30 57 (11.0%) 38 (9.2%) 0.4

STE-ACS 167 (21.5%)* 67 (44.1%)* 0.01 95 (18.2%)* 139 (34.2%)* <0.001

NSTE-ACS 609 (78.5%)* 85 (55.9%)* <0.001 426 (81.8%)* 268 (65.8%)* <0.001

Door to balloon time of STE-ACS patients (Min) 54.9±41.6* 68.9±35.1* 0.05 55.0±49.0 61.6±37.7 0.3

Number of lesions with Stenosis ≥50% 3.3±2.0* 3.0±1.8* 0.06 3.3±2.1 3.3±1.8 0.6

Number of stents implanted per patient 1.6±0.9 1.2±0.5 0.6 1.6±0.9 1.6±0.9 0.8

Peak Troponin I (ng/L) 14.7±22.1* 23.0±26.2* 0.06 11.1±18.0* 23.1±27.4* <0.001

Highest Creatinine Value within 72 Hours (µmol/dL) 115±132 104±77 0.08 107±93 118±149 0.5

Trough Hemoglobin Value within 72 Hours (g/dL) 13.9±1.8 13.8±1.8 0.8 14.2±3.5 14.2±7.2 0.2

Baseline platelet count (×10³ cells per mm³) 238±63 244±71 0.6 229±60* 250±68* <0.001

Platelet Reactivity Tests:

Admission to First PR test (Days) 2.3±2.6* 2.0±2.0* 0.05 2.5±2.5* 2.0±2.6* 0.001

On prasugrel or ticagrelor 126 (16.3%) 39 (23.7%) <0.001 104 (20.0%)* 58 (14.2%)* 0.007

Initial ASPI test (AU*min) 160±70* 492±241* <0.001 166±125* 276±196* <0.001

Initial ADP test (AU*min) 432±274* 785±346* <0.001 263±107* 780±250* <0.001

Initial Platelet Reactivity Test

High initial ASPR

Odds ratio (95% confidence interval) Adjusted for GRACE score 7.46 (2.54−21.90) 1.41 (0.54−3.69) 1.14 (0.63-2.06)

(≥468 AU*min)¶ Adjusted for GRACE score 5.01 (1.38−18.18) 1.381 (0.609-3.133) 0.71 (0.44-1.15) Odds ratio (95% confidence interval) Adjusted for initial ASPR and GRACE score 1.001 (.999-1.003) -

Odds ratio (95% confidence interval)

Odds ratio (95% confidence interval)

Platelet reactivity (PR) testing has prognostic value in patients with

acute coronary syndrome (ACS) undergoing percutaneous

coronary intervention (PCI) There are conflicting data on the

optimal type and timing of PR testing We investigated the

prognostic value of high on-aspirin PR (ASPR) and high on-ADP

receptor antagonist PR (ADPR) in ACS patients on dual antiplatelet

therapy who were managed invasively

We measured ASPR and ADPR using the Multiplate ASPI

(arachidonic acid agonist) and ADP (adenosine diphosphate

agonist) tests respectively, immediately before (initial test) and

24-48 hours after (final test) angiography and PCI All patients were

monitored for intra-procedural thrombotic events (IPTE), in

accordance with the ACUITY definition, 30-day and 12-month

major adverse cardiovascular and cerebrovascular events

(MACCE)

Figure.3

Figure 4

Fig 1: Study Flow

Platelet Reactivity (PR)

Acute Coronary Syndrome (ACS)

Percutaneous Coronary Intervention (PCI)

On-Aspirin PR (ASPR)

On-ADP receptor antagonist PR (ADPR)

Intra-Procedural Thrombotic Events (IPTE)

Major Adverse Cardiovascular and Cerebrovascular

Events (MACCE)

Hazard Ratio (HR)

Dual antiplatelet therapy (DAPT)

Adenosine Diphosphate (ADP)

ABBREVIATIONS

BACKGROUND

Funding source: The study was funded by the National Medical Research Council of Singapore (NMRC/CSA/028/2010) with platelet reactivity analysers and test kits supplied by Roche

Diagnostics (Basel Switzerland) Both sponsors had no role in the study design, site selection, data collection, data analysis, or data interpretation, but Roche Diagnostics had the right to a non-binding review of the manuscript before submission

Disclosures: A/Prof Mark Chan and Professor Mark Richards receive research funding from Roche Diagnostics (Basel Switzerland) and are on the speaker’s bureau of Roche Diagnostics

*P<0.05

Presented at ACC 2016

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Copyright © 2008 National University Health System

TROPICAL-ACS

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