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Keith A A Fox Edinburgh Centre for Cardiovascular Science

AHA Hotline 13 th November 2011. TRA-CER Study Discussant. Keith A A Fox Edinburgh Centre for Cardiovascular Science. Do we need additional anti-thrombotic therapies after ACS?. Cumulative Death rate: by ST Group (landmark analysis: >15 days). In subsequent 5 years: (non STEMI)

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Keith A A Fox Edinburgh Centre for Cardiovascular Science

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  1. AHA Hotline 13th November 2011 TRA-CER Study Discussant Keith A A Fox Edinburgh Centre for Cardiovascular Science

  2. Do we need additional anti-thrombotic therapies after ACS? Cumulative Death rate: by ST Group (landmark analysis: >15 days) In subsequent 5 years: (non STEMI) 22% deaths, 12.7% had > 1 MI 7.7% had > 1 stroke 53.6% had > 1 ACS readmission ST depression HR 0.85, 95% CI 0.75–0.97P=0.02 ST elevation vs ST depression Adjusted for baseline risk ST elevation No ST deviation N=46,829 Days 83% of 5yr deaths (81% CV deaths) were post discharge and despite secondary prevention Fox KAA et al Nature clin practice 2008, 5; 580-9 Eur Heart j 2010; 31: 2755-64

  3. Additional anti-thrombotic therapy after ACS Risk versus benefit:Where is the “sweet spot”? • Prasugrel and ticagrelor superior to clopidogrel • Apixaban APPRAISE 2 ACS (full A fib dose), excess bleeding, no benefit • Rivaroxaban (ATLAS TIMI 51): AHA 2011 • Platelet thrombin receptor (PAR-1) antagonists: • Atopaxar (LANCELOT phase 2 trials) “encouraging” ...but some additional bleeding, QTc , liver enzymes • Vorapaxar (TRAP2P-TIMI 50) ongoing (DSMB: discontinue Rx in those with prior stroke) • Vorapaxar (TRACER) stopped early (predefined # “primary and secondary endpoints attained”)

  4. TRACER: risk vs possible benefit Increased GUSTO Moderate/Severe Bleeding HR 1.35 (95%CI 1.16-1.58) p<0.001 Absolute Excess (2yr): 2 mod/severe bleeds ~ 1 additional ICH Increased ICH HR 3.39 (95% CI 1.78-6.45) p<0.001 * MI HR 0.88 (0.79–0.98)

  5. TRACER Interpretation & implications • Placebo study population had a clinically important event rate at 2yr: 6.1% death, 12.5% MI, 2.1% stroke NB: half of the events in first 4 months • Continuing risk of bleeding: moderate, severe, ICH NB: ~ 80% ICH after 4 months • Primary endpoint non-significant (? impact on MI) NB:“Softer” endpoints just added noise • Risk vs benefit not worthwhile in the tested dose and study population • Potential remains to reduce thrombotic mediated events after ACS: TRA-CER missed the “sweet spot” between efficacy and safety

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