Pretrattamento con Antiaggreganti Piastrinici nelle SCA. No, Sempre Necessario

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1 9 MEETING CARDIOLUCCA CONTROVERSIA D AUTORE: PRETRATTAMENTO CON ANTIAGGREGANTI PIASTRINICI NELLE SCA Lucca, Auditorium S. Francesco Novembre 2013 Pretrattamento con Antiaggreganti Piastrinici nelle SCA. No, Sempre Necessario Leonardo De Luca, M.D., Ph.D., F.A.C.C. Department of Cardiovascular Sciences Interventional Cardiology Unit European Hospital Rome, Italy leo.deluca@libero.it

2 Antiplatelet Therapy As Soon As Possible in ACS E. Montale J.F. Kennedy N. Boileau T.H. Huxsely A. Manzoni T. Guerra

3 Antiplatelet Therapy As Soon As Possible in ACS Il tempo degli eventi èdiverso dal nostro Eugenio Montale

4 Delay to Angiography in High-Risk NSTE-ACS Patients: Results from the GRACE high-risk NSTE-ACS patients in 14 countries with varying healthcare systems with a mean GRACE risk score of 128 Swanson N, et al. Heart 2009;95:211

5 Timing to Coronary Angiography Koh A, et al. Am J Cardiovasc D 2012;2:248

6 The APTOR Observational Study: Time from Hosp-Admission to PCI in NSTEMI Bakhai A, et al. Eurointervention 2011;6:992

7 NSTEACS: Use of Coronary Angiography Urgent Cath Non-urgent Cath 85,6 88,9 Coronary Angiography (%) 69,3 Unpublished Data Presented at the Annual ANMCO Meeting, 2010

8 Antiplatelet Therapy As Soon As Possible in ACS We must use time as a tool, not as a couch J.F. Kennedy

9 Population Trends in Percutaneous Coronary Intervention 20-Year Results From the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) % Fokkema ML, et al. J Am Coll Cardiol 2013;61:1222

10 Antiplatelet Therapy As Soon As Possible in ACS La scienza non è altro che buon senso addestrato e organizzato. Thomas H. Huxley

11 DAPT History 4.0 Aspirin % Primary Endpoint (%) Aspirin and Warfarin Aspirin and Ticlopidine Days after Stenting Schoemig N Engl J Med 1996;334:1084 STARS investigators, N Engl J Med 1998;339:1665

12 Clinical Use of P 2 Y 12 Blockers in Late 90s NSTEMI STEMI Elective PCI Ticlopidine SAT prevention

13 CURE: Very Early Efficacy of Clopidogrel in NSTE ACS Cumulative Hazard Rate CV Death, MI, Stroke, Severe Ischemia Within First 24 Hours Placebo + Aspirin (n=6303) Clopidogrel + Aspirin (n=6259) Hours After Randomization 34% Relative Risk Reduction P=.003 Yusuf S et al. Circulation 2003;107:966

14 Pre-Treatment with Clopidogrel Prior to PCI and Stenting in ACS Patients Cumulative Hazard Rate Composite of MI, urgent revascularization or cardiovascular death at 30 Days Placebo pretreated Clopidogrel pretreated Days of follow-up p=0.017 ( ) 0.90) 44% Relative Risk Reduction * In addition to other standard therapies. * Patients did not receive open-label thienopyridine before PCI. Mehta SR et al for the CURE Investigators. Lancet. 2002

15 Clinical Use of Clopidogrel in Contemporary Practice NSTEMI STEMI Elective PCI Clopidogrel SAT Prevention Prevention of ischemia

16 CREDO Study: Timing of Loading Dose and 28-Day Endpoint Timing N Pretreat No Pretreat 3 <6 h RRR: 13.4% p= h CREDO Overall RRR: 38.6% p=0.05 RRR: 18.5% P= Hazard Ratio (95% CI) Steinhubl SR, et al. JAMA. 2002;288:2411

17 Meta-Analysis of Clopidogrel Pretreatment MI before PCI (%) Clopidogrel No Trial Pretreatment Pretreatment PCI-CURE CREDO n/a n/a PCI-CLARITY Overall Favors Pretreatment Favors No Pretreatment OR: 0.67 p=0.005 CV Death or MI after PCI (%) OR (95% CI) Clopidogrel No Trial Pretreatment Pretreatment PCI-CURE CREDO PCI-CLARITY Overall OR: 0.71 p= OR (95% CI) Sabatine MS, et al. JAMA 2005;294:1224

18 ESC Recommendations for Oral Antiplatelet Agents Guidelines on myocardial revascularization Wijns W, et al. Eur Heart J 2010;31:2501 Guidelines for the management of NSTE-ACS Hamm CW, et al. Eur Heart J Sep 21. [Epub ahead of print]

19 Antiplatelet Therapy As Soon As Possible in ACS Il buon senso c era; ma se ne stava nascosto, per paura del senso comune Alessandro Manzoni

20 Timing of Angiography and Long-Term Outcomes in NSTE-ACS Long-term follow-up after early (within 2 days) angiography versus delayed (within 3-5 days) angiography among 2721 pts from the FRISC-II, ICTUS and RITA-3 (FIR) patient-pooled database Damman P, et al. J Am Coll Cardiol Intv 2012;5:191

21 Time to Cath Lab Is Rapidly Decreasing PCI-CURE (Lancet 2001) 6 Days FRISC (Lancet 1999) 4 Days RITA-3 (Lancet 2002) 3 Days CRUSADE (Circ 2003) 23.4 h ACUITY (NEJM 2006) 19.7 h CHAMPION PLATFORM (NEJM 2009) 6.3 h PLATO INVASIVE (Lancet 2010) 2.4 h

22 Definite Acute ST in Recent Clinical Trials without Pre-Treatment with APLT: Back to the Future? New Drug Comparator Arms Stone GW, et al. N Engl J Med 2007 Wiviott SD, et al. N Engl J Med 2007 Bhatt DL, et al. N Engl J Med 2013

23 Clopidogrel and Pre-Treatment in PCI: A Meta-Analysis 8608 patients out of 7 RCTs undergoing PCI, including NSTEACS, STEMI, and elective PCI Absolute risk, % OR: 0.80 P=0.17 OR: 0.77 P<0.001 NNT: 40 PCI Cure Relative Weight, % Bellemain-Appaix A, et al. JAMA. 2012;308:2507

24 Clopidogrel and Pre-Treatment in PCI: A Meta-Analysis Bellemain-Appaix A, et al. JAMA. 2012;308:2507

25 Clopidogrel and Pre-Treatment in PCI: A Meta-Analysis STABLE ACS Bellemain-Appaix A, et al. JAMA. 2012;308:2507

26 Clopidogrel and Pre-Treatment in PCI: A Meta-Analysis Bellemain-Appaix A, et al. JAMA. 201terial2;308 Supplemental material,

27 Timing of Enrollment ACS Patient UA/NSTEMI STEMI Enrollment Hospital Course Admission Initial Management Angiography PCI CABG Etc. Other Decision Pathways Other Decision Pathways 27 James S, et al. Am Heart J. 2009;157:599 Wallentin L, et al. N Engl J Med. 2009;361:1045 Confidential for AstraZeneca Discussion Purposes Only

28 Timing of Enrollment ACS Patient UA/NSTEMI STEMI Enrollment Hospital Course Admission Angiography PCI 28 James S, et al. Am Heart J. 2009;157:599 Wallentin L, et al. N Engl J Med. 2009;361:1045 Confidential for AstraZeneca Discussion Purposes Only

29 Primary End-Point Events Over the First 10 Days by Timing of Thienopyridine Loading in TRITON Hours from PCI Start FDA Prasugrel Action Package

30 Antiplatelet Therapy As Soon As Possible in ACS Spesso la paura di un male ci conduce a uno peggiore. Nicolas Boileau

31 Patients Presenting with NSTE-ACS in the United States Burke MA, et al. Am Heart J 2011;161:832

32 Outcomes Following Pre-Op. Clopidogrel in Patients with ACS Undergoing CABG p=0.052 p=0.002 p=0.59 p=0.02 P=0.36 p=0.004 Erbrahimi R, et al. J Am Coll Cardiol 2009 ;53:1965

33 Factors Contributing to the Lower Mortality with Ticagrelor among Pts undergoing CABG in PLATO Death due to Bleeding Death due to Infection Verenhorst C, et al. J Am Coll Cardiol, in press

34 Antiplatelet Therapy As Soon As Possible in ACS Non è vero che uno più uno fa sempre due; una goccia più una goccia fa una goccia più grande (T. Guerra)

35 ACCOAST Design Schema NSTEMI + Troponin 1.5 times ULN local lab value Clopidogrel naive or on long term clopidogrel 75 mg Randomize 1:1 Double-blind n~4100 (event driven) Prasugrel 30 mg Placebo CABG or Medical Management (no more prasugrel) Coronary Angiography Prasugrel 30 mg Coronary Angiography Prasugrel 60 mg CABG or Medical Management (no prasugrel) PCI PCI Prasugrel 10 mg or 5 mg (based on weight and age) for 30 days 1 Endpoint: CV Death, MI, Stroke, Urg Revasc, GP IIb/IIIa bailout, at 7 days Montalescot G et al. Am Heart J 2011;161:650

36 ACCOAST Design Schema NSTEMI + Troponin 1.5 times ULN local lab value Clopidogrel naive or on long term clopidogrel 75 mg Randomize 1:1 Double-blind n~4100 (event driven) Prasugrel 30 mg Placebo CABG or Medical Management (no more prasugrel) Coronary Angiography Prasugrel 30 mg Coronary Angiography Prasugrel 60 mg CABG or Medical Management (no prasugrel) PCI PCI Prasugrel 10 mg or 5 mg (based on weight and age) for 30 days 1 Endpoint: CV Death, MI, Stroke, Urg Revasc, GP IIb/IIIa bailout, at 7 days Montalescot G et al. Am Heart J 2011;161:650

37 ACCOAST Design Schema NSTEMI + Troponin 1.5 times ULN local lab value Clopidogrel naive or on long term clopidogrel 75 mg Randomize 1:1 Double-blind n~4100 (event driven) Prasugrel 60 mg Placebo CABG or Medical Management (no more prasugrel) Coronary Angiography Coronary Angiography Prasugrel 60 mg CABG or Medical Management (no prasugrel) PCI PCI Prasugrel 10 mg or 5 mg (based on weight and age) for 30 days 1 Endpoint: CV Death, MI, Stroke, Urg Revasc, GP IIb/IIIa bailout, at 7 days Montalescot G et al. Am Heart J 2011;161:650

38 ACCOAST Design Schema NSTEMI + Troponin 1.5 times ULN local lab value Clopidogrel naive or on long term clopidogrel 75 mg Randomize 1:1 Double-blind n~4100 (event driven) NIH Prasugrel Clinical 30 Center: mg Ethics in Clinical Placebo Research CABG Among elements that make for poor and theredore unethical science are: or Coronary Coronary Medical Angiography Angiography Excessive risk compared to benefits Management (no more prasugrel) Inadequate power Poor selection Prasugrel and misallocation 30 mg of participants Prasugrel 60 mg Midstream changes of protocol Inappropriate allocation PCI of dosages PCI Prasugrel 10 mg or 5 mg (based on weight and age) for 30 days CABG or Medical Management (no prasugrel) 1 Endpoint: CV Death, MI, Stroke, Urg Revasc, GP IIb/IIIa bailout, at 7 days Montalescot G et al. Am Heart J 2011;161:650

39

40 4.4 hrs Pre-Rx 30 mg 30 mg No Pre-Rx 60 mg

41 ACCOAST Trial Screening to Enrollment: a Long Way to Go patients enrolled in 3 years at 171 centers in 19 countries 0,6 pts enrolled per center/month Exclusion criteria included having a medical history considered a contraindication for therapy with prasugrel (eg, history of stroke or transient ischemic attack) and undergoing treatment with any thienopyridine LD or a ticlopidine or prasugrel MD within 7 days of study entry.

42 ACCOAST: Baseline Characteristics Characteristic Prasugrel pretreatment arm (n=2037) No pretreatment arm (n=1996) Mean age, years Female sex, n (%) 552 (27.1) 558 (28.0) Mean weight, kg BMI 30 kg/m 2, n (%) 591 (29.0) 562 (28.2) GRACE score, n/n (%) < /1984 (75.8) 1526/1947 (78.4) /1984 (24.2) 421/1947 (21.6) Creatinine clearance 30 ml/min, n/n (%) 65/2016 (3.2) 46/1972 (2.3) Killip class 1, (%) 1956 (96.0) 1924 (96.4) Coronary angiography results, (%) No significant disease 541 (26.6) 512 (25.7) 1 vessel 830 (40.8) 805 (40.4) Median intervals, hours Symptom onset to first loading dose First loading dose to start of coronary angiography BMI, body mass index; GRACE, The Global Registry of Acute Coronary Events Montalescot G, et al. N Engl J Med 2013;369:999

43 Conclusions 1. Antiplatelet agents are a mainstay of the treatment of ACS for the prevention of acute thrombotic and recurrent ischemic events; 2. Current guidelines from the ESC and the ACC/AHA give a class I recommendation for pretreatment in all types of ACS; 3. Soon after a diagnosis of ACS has been made, start the best available pharmacological therapy

44 30-Day Events in TRITON and ACCOAST at a Glance 300 mg Clopidogrel (downstream) 30 mg Prasugrel (upstream) + 30 mg Prasugrel (downstream) 60 mg Prasugrel (downstream) % * 30 days TIMI Major Bleeds 30 days * PCI Subgroup Wallentin L, et al. N Engl J Med. 2009;361:1045 Montalescot G, et al. N Engl J Med 2013;369:999

45 Primary Endpoint at 30 Days in Clopidogrel Pre-Rx and Prasugrel Trials Clopidogrel 600 mg 3.9 Pretreatment *Primary endpoint in PCI CURE: CV death, MI, urgent TVR Primary endpoint in PCI CLARITY, CURRENT and TRITON: CV death, MI, stroke Overall STEMI Cohort Lancet 2001;358:527 JAMA 2005;294:1224 Lancet 2010; 376: 1233 N Engl J Med. 2007;357:2001 Lancet. 2009;373:723

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