New insights in stent thrombosis: Platelet function monitoring. Franz-Josef Neumann Herz-Zentrum Bad Krozingen

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1 New insights in stent thrombosis: Platelet function monitoring Franz-Josef Neumann Herz-Zentrum Bad Krozingen

2 New insights in stent thrombosis: Platelet function monitoring Variability of residual platelet function with conventional antiplatelet therapy Residual platelet function as predictor of stent thrombosis Inconsistency of platelet function tests? Replacement of platelet function monitoring by clinical characteristics? Therapeutic consequences?

3 New insights in stent thrombosis: Platelet function monitoring Variability of residual platelet function with conventional antiplatelet therapy Residual platelet function as predictor of stent thrombosis Inconsistency of platelet function tests? Replacement of platelet function monitoring by clinical characteristics? Therapeutic consequences?

4 number of patients Variable Platelet Responses After Clopidogrel Loading ADP-induced (5 µmol/l) platelet aggregation 4-24 hours after 300 mg clopidogrel Serebruany VL et al., J Am Coll Cardiol 2005

5 Platelet Aggregation After Clopidogrel Loading Hochholzer W et al., Circulation 2005 Maximal aggregation 5 µmol/l ADP (%) Time from loading dose to catheterisation (h)

6 Platelet Function After Clopidogrel Maintenance Dose Proportion of population (%) Residual platelet aggregation (%) ADP 5 mmol/l Trenk D et al., J Am Coll Cardiol 2008

7 New insights in stent thrombosis: Platelet function monitoring Variability of residual platelet function with conventional antiplatelet therapy Residual platelet function as predictor of stent thrombosis Inconsistency of platelet function tests? Replacement of platelet function monitoring by clinical characteristics? Therapeutic consequences?

8 Platelet Aggregation After Clopidogrel Loading Hochholzer W et al., Circulation 2005 Maximal aggregation 5 µmol/l ADP (%) Time from loading dose to catheterisation (h)

9 Impact of Platelet Aggregation During PCI on Outcome 30-Day MACE (%) 5 4 p = /209 1/198 6/196 7/199 1st quartile 2nd quartile 3rd quartile 4th quartile (< 4 %) (4 13 %) (14 32 %) (> 32 %) Hochholzer W et al., J Am Coll Cardiol 2006

10 Clinical Impact of Platelet Aggregation Above Median A) Adjustment None Demographic, clinical, and angiographic variables* Above variables + time from clopidogrel loading Above variables + baseline platelet aggregation Odds ratio of 30-day MACE for platelet aggregation before PCI above median B) Hochholzer Adjustment W et al., J Am Coll Cardiol 2006 Odds ratio of 30-day MACE per 10 % increase in platelet aggregation before PCI

11 Prognostic Impact of Various Non-Responder Definitions 30-Day MACE (%) 4 P=0.03 P=0.56 P=0.51 Inadequate Adequate Response Below median Aggregation 10% % Inhibition < 10% Non-Responder Definitions Hochholzer W et al., ESC 2005

12 Platelet Function After Clopidogrel Maintenance Dose Proportion of population (%) Residual platelet aggregation (%) ADP 5 mmol/l Trenk D et al., J Am Coll Cardiol 2008

13 Prognostic Impact of On-Treatment Platelet Reactivity Death or MI (%) 8 6 Log-Rank P =.004 RPA > 14% 4 2 RPA 14% Days after PCI Trenk D et al., J Am Coll Cardiol 2008

14 Prognostic Impact of On-Treatment Platelet Reactivity Hazard ratio of 1-year death/mi for platelet aggregation > 14 % Unadjusted Adjusted Trenk D et al., J Am Coll Cardiol 2008

15 Death or MI (%) Death or myocardial infarction (%) On-Treatment Platelet Reactivity and Stent Type A RPA > 14% RPA 14% Days after PCI No. at Risk BMS Trenk D (> et 14%) al., J Am 147 Coll Cardiol BMS Log-Rank P =.127 DES Log-Rank P =.004

16 Stent Thrombosis in Clopidogrel Nonresponders Buonamici P et al., J Am Coll Cardiol 2007

17 Post-Loading Platelet Reactivity to 20 µmol/l ADP and 3-Month Incidence of CV-Death, MI and Stroke N = 379 Geisler T et al., Eur Heart J 2006

18 Prediction of risk after DES by bedside test (VerifyNow) Cardiovascular death, infarction, stent thrombosis N = 380 Price MJ et al., Eur Heart J 2008

19 Prediction of risk after DES by bedside test (VerifyNow) 30-day incidence of MACE (%) 25 P = year incidence of death & MI (%) 25 p= PRU > 240 PRU < N = 160 Patti G et al., J Am Coll Cardiol N = 683 Marcucci R et al., Circulation 2009

20 Prediction of risk after DES by bedside test (MultiPlate) 30-day incidence (%) 2.5 P< day incidence (%) 2.5 p= Low responders Not low responders Not high responders High responders N = Stent thrombosis TIMI major bleed Sibbing et al., J Am Coll Cardiol 2009

21 New insights in stent thrombosis: Platelet function monitoring Variability of residual platelet function with conventional antiplatelet therapy Residual platelet function as predictor of stent thrombosis Inconsistency of platelet function tests? Replacement of platelet function monitoring by clinical characteristics? Therapeutic consequences?

22 Intraindividual consistency of aggregometry Difference day 3 day 28 (%) Median, Quartiles + 5 % 0 % - 4 % N = Trenk D, et al. unpublished RPA ADP 5 µm

23 VerifyNow P 2 Y 12 PRU Light transmission aggregometry and VerifyNow Trenk D et al., unpublished r 2 = p< n= RPA ADP 5 µm, %

24 MP AUC ADP, AU min Light transmission aggregometry and MultiPlate Trenk D et al., unpublished r 2 =0.263 p< n= RPA ADP 5 µm, %

25 Sensitivity ROC - curve for VerifyNow vs. EXCELSIOR Criterion Trenk D et al., unpublished Area: % CI: Specificity

26 New insights in stent thrombosis: Platelet function monitoring Variability of residual platelet function with conventional antiplatelet therapy Residual platelet function as predictor of stent thrombosis Inconsistency of platelet function tests? Replacement of platelet function monitoring by clinical characteristics? Therapeutic consequences?

27 PREDICT score predicts high residual platelet reactivity Score Variables: Age > 65 years 1 Acute coronary syndrome 1 Renal failure 2 Diabetes mellitus 2 Left ventricular dysfunction 3 Geisler T et al., J Thromb Haemost 2008

28 Age and obesity predict clopidogrel response Hochholzer W et al, J Am Coll Cardiol 2010

29 Age, obesity and diabetes predict clopidogrel response Hochholzer W et al, J Am Coll Cardiol 2010

30 Poor prediction of clopidogrel response: Clinical characteristics Hochholzer W et al, J Am Coll Cardiol 2010

31 Poor prediction of clopidogrel response: Clinical characteristics plus CYP 2C19*2 Hochholzer W et al, J Am Coll Cardiol 2010

32 Genotyping: Poor substitute for phenotyping 22% 41% 47% >14% Hochholzer W et al, J Am Coll Cardiol 2010

33 Clopidogrel responders among CYP 2C19*2 carriers Proportion with low residual platelet aggregation (%) % 53% % n=175 n=52 n=10 *1/*1 *1/*2 *2/*2 CYP 2C19 *2 genotype Geisler T et al., Pharmacogenomics 2008

34 New insights in stent thrombosis: Platelet function monitoring Variability of residual platelet function with conventional antiplatelet therapy Residual platelet function as predictor of stent thrombosis Inconsistency of platelet function tests? Replacement of platelet function monitoring by clinical characteristics? Therapeutic consequences?

35 Interpatient Variability Interpatient Variability Variability of residual platelet function: A clopidogrel-related problem Inhibition of platelet aggregation (%) Clopidogrel 300 mg Clopidogrel Responder Clopidogrel Non-responder Prasugrel 60 mg Brandt et al. Am Heart J 2007

36 % of participants Reduced risk of stent thrombosis by prasugrel - The TRITON Study % Clopidogrel HR 0.48 ( ) P < Prasugrel 1.13% Days Wiviott SD et al., Lancet 2008

37 Dilemma of antithrombotic therapy: Prevention of ischemic events vs. risk of bleeding Risk Ischemic events Bleedings Antithrombotic effect

38 Prasugrel: Favourable balance of safety and efficacy Proportion of population (%) 15 Cardiovascular death / non-fatal myocardial infarction / non-fatal stroke Clopidogrel 10 Prasugrel Hazard ratio: 0.81 ( ) NNT Major non-cabg bleeds Prasugrel Clopidogrel Days Wiviott SD et al., N Engl J Med Hazard ratio 1.32 ( ) NNH 167

39 Triton TIMI 38: A study in acute coronary syndromes Patients with ST-elevation myocardial infarction Ischaemic symptoms 12 h of enrolment if primary PCI Within 14 days of medical treatment for STEMI and known cardiac anatomy Patients with non-st-elevation acute coronary syndrome Ischaemic symptoms persisting <72 h prior to randomisation TIMI risk score 3 ST-segment depression 1 mm or increased levels of cardiac necrosis markers Known cardiac anatomy Wiviott SD et al., N Engl J Med 2007

40 Tailored antiplatelet therapy: Open questions in elective patients? Efficacy of increased platelet inhibition? Risk-benefit ratio of increased platelet inhibition? Identification of patients at risk by bed-side assays? Risk marker or risk factor?

41 Tailored antiplatelet therapy after elective PCI: On-going studies? GRAVITAS: VerifyNow on standard clopidogrel PRU > 230 Clopidogrel 75 mg vs. 150 mg N = 2200, US sites TRIGGER-PCI: VerifyNow on standard clopidogrel PRU > 208 Clopidogrel 75 mg vs. prasugrel 10 mg N = 2150, German and US sites

42 New insights in stent thrombosis: Platelet function monitoring Residual platelet function is a strong independent predictor of stent thrombosis. Standard laboratory tests and bedside tests yield essentially consistent results. Clinical characteristics and currently known genetic markers are poor predictors of residual platelet function. On-going large clinical studies are assessing the benefit of tailored antiplatelet therapy in elective PCI.

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