DUAL ANTIPLATELET THERAPY. Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania

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1 DUAL ANTIPLATELET THERAPY Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania

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3 DUAL ANTIPLATELET THERAPY (DAPT) Dual antiplatelet regimen Acetylsalicylic acid (ASA) plus clopidogrel, Acetylsalicylic acid (ASA)Plus Prasugrel or Acetylsalicylic acid (ASA)Plus Ticagrelor. Guidelines recommend the indefinite use of ASA after an ACS event, Duration of clopidogrel, prasugrel or ticagrelor therapy varies based on patient characteristics.

4 DUAL ANTIPLATELET THERAPY CURRENT STANDARD OF CARE SECONDARY PREVENTION OF ACUTE CORONARY SYNDROME Thrombosis Bleeding

5 ASPIRIN /PLACEBO VS ASA/CLOPIDOGREL

6 Cumulative Hazard Rate PRIMARY END POINT - MI/STROKE/CV DEATH Placebo + ASA* 11.4% 9.3% ASA* * In combination with standard therapy The CURE Trial Investigators. N Engl J Med. 2001;345: Months of Follow-Up 20% RRR P < N = 12,562

7 Cumulative Hazard Rate MI/STROKE/CV DEATH WITHIN 30 DAYS Placebo + ASA* ASA* Days of Follow-Up * In combination with standard therapy The CURE Trial Investigators. N Engl J Med. 2001;345: % RRR P = N = 12,562

8 PCI-CURE Cumulative Hazard Rate OVERALL LONG-TERM RESULTS Composite of cardiovascular death or MI from randomization to end of follow-up 0.15 Placebo + ASA* 12.6% % + ASA* * In combination with standard therapy 31% RRR P = N = Days of follow-up Mehta, SR. et al for the CURE Trial Investigators. Lancet. August 2001.

9 PCI-CURE Cumulative Hazard Rate 30 DAY RESULTS Composite of cardiovascular death, MI, or urgent revascularization Placebo + ASA* 6.4% ASA* Days of follow-up 4.5% 30% RRR P = 0.03 N = 2658 * In combination with standard therapy Mehta, SR. et al for the CURE Trial Investigators. Lancet. August 2001;21:

10 ASPIRIN /PLACEBO VS ASA/CLOPIDOGREL

11 % Incidence ARMYDA-2 TRIAL: PRIMARY ENDPOINT 14% 12% 10% 8% 6% 4% 2% Primary Composite of death, MI, and target vessel revascularization p = % 12% The primary composite endpoint of death, MI, target vessel revascularization was significantly lower in the highdose clopidogrel group at 30 days There was one TVR in the high-dose group and no deaths in either arm 0% High-Dose Standard Dose Presented at ACC 2005

12 PUBLICATION OF PRIMARY RESULTS NEJM 357: , Slides and Full Listing of Trial Participants at

13 Primary Endpoint (%) 15 Primary Endpoint CV Death,MI,Stroke 12.1 (781) 10 5 HR 0.77 P= HR 0.80 P= Prasugrel 9.9 (643) HR 0.81 ( ) P= NNT= 46 0 ITT= 13,608 LTFU = 14 (0.1%) Days

14 Endpoint (%) Stent Thrombosis (ARC Definite + Probable) 3 2 Any Stent at Index PCI N= 12, (142) 1 Prasugrel 1.1 (68) HR 0.48 P < NNT= Days

15 Endpoint (%) Stent Thrombosis (ARC Definite + Probable) 3 2 Any Stent at Index PCI N= 12, (142) 1 Prasugrel 1.1 (68) HR 0.48 P < NNT= Days

16 Endpoint (%) Balance of Efficacy and Safety CV Death / MI / Stroke Prasugrel events HR 0.81 ( ) P= NNT = TIMI Major NonCABG Bleeds Days Prasugrel events HR 1.32 ( ) P=0.03 NNH = 167

17 Endpoint (%) Net Clinical Benefit Death, MI, Stroke, Major Bleed (non CABG) 15 ITT= 13, Prasugrel HR 0.87 P=0.004 Events per 1000 pts MI Days + 6 Major Bleed (non CABG) All Cause Mortality Clop 3.2% Pras 3.0 % P=0.64

18 Prior Stroke / TIA Yes No Net Clinical Benefit Bleeding Risk Subgroups Post-hoc analysis P int = Risk (%) Age >=75 < 75 P int = Wgt < 60 kg +3 >=60 kg P int = OVERALL Prasugrel Better HR Better

19 August 30, 2009 at CET

20 Cumulative Incidence (%) Days BRILINTA PLATO: Primary Efficacy Endpoint (Composite of CV Death, MI, or Stroke) 0 12 Months ARR=0.6% RRR=12% P=0.045 HR: 0.88 (95% CI, ) BRILINTA ARR=1.9% RRR=16% NNT=54* P<0.001 HR: 0.84 (95% CI, ) No. at risk Months After Randomization BRILINTA 9,333 8,628 8,460 8,219 6,743 5,161 4,147 9,291 8,521 8,362 8,124 6,650 5,096 4,047 Both groups included aspirin. *NNT at one year. Wallentin L, et al. N Engl J Med. 2009;361:

21 PLATO-defined Total Major Bleeding (%) PLATO: Primary Safety Endpoint BRILINTA 11.6% 11.2% P=NS 5 0 P=0.43 HR: 1.04 (95% CI, ) No. at risk Days From First Dose BRILINTA 9,235 7,246 6,826 6,545 5,129 3,783 3,433 9,186 7,305 6,930 6,670 5,209 3,841 3,479 Both groups included aspirin. Wallentin L, et al. N Engl J Med. 2009;361:

22 BRILINTA Indication By Diagnosis By Treatment UA/NSTEMI STEMI Medical management PCI CABG BRILINTA, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) If clinically indicated, BRILINTA should be used with caution in the following patient groups: Patients with concomitant administration of medicinal products that may increase the risk of bleeding (eg, non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of BRILINTA dosing BRILINTA: Approved package insert.

23 K-M Estimated Rate (% Per Year) PLATO: Bleeding NS P = BRILIQUE BRILINTA (n=9,235) (n=9,186) Major Bleeding 5.8 NS 5.8 Life-threatening/ Fatal Bleeding NS Fatal Bleeding Major and Minor Bleeding P = Non-CABG- Major Bleeding 7.4 NS 7.9 CABG-Major Bleeding All values presented by PLATO criteria. Both groups included aspirin. Wallentin L, et al. N Engl J Med. 2009;361:

24 Treated With an Initial Invasive or Ischemia-Guided Strategy (cont d) Recommendations COR LOE A P2Y 12 inhibitor (either clopidogrel or ticagrelor) in addition to aspirin should be administered for up to 12 months to all patients with NSTE-ACS without contraindications who are treated with either an early invasive or ischemia-guided strategy. Options include: I B : 300-mg or 600-mg loading dose, then 75 mg daily Ticagrelor : 180-mg loading dose, then 90 mg twice daily B The recommended maintenance dose of aspirin to be used with ticagrelor is 81 mg daily.

25 Antiplatelet Therapy to Support Primary PCI for STEMI I IIa IIb III A loading dose of a P2Y 12 receptor inhibitor should be given as early as possible or at time of primary PCI to patients with STEMI. Options include: 600 mg; or Prasugrel 60 mg; or Ticagrelor 180 mg

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