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Prasugrel Compared to Clopidogrel in Patients with Acute Coronary Syndromes Undergoing PCI with Stenting: the TRITON -

STENT ANALYSIS. Prasugrel Compared to Clopidogrel in Patients with Acute Coronary Syndromes Undergoing PCI with Stenting: the TRITON - TIMI 38 Stent Analysis .

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Prasugrel Compared to Clopidogrel in Patients with Acute Coronary Syndromes Undergoing PCI with Stenting: the TRITON -

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  1. STENT ANALYSIS Prasugrel Compared to Clopidogrel in Patients with Acute Coronary Syndromes Undergoing PCI with Stenting: the TRITON - TIMI 38 Stent Analysis Stephen D. Wiviott, Elliott M. Antman, Ivan Horvath, Matyas Keltai, Jean-Paul R. Herrman, Frans van de Werf, William Downey, Benjamin M. Scirica, Sabina A. Murphy, Carolyn H. McCabe, Eugene Braunwald. SCAI – ACCi2 2008Chicago, Illinois Disclosure Statement: The TRITON-TIMI 38 trial was supported by a research grant to the Brigham and Women’s Hospital from Daiichi Sankyo Co. Ltd and Eli Lilly & Co.

  2. Main Trial Design STENT ANALYSIS ACS (STEMI or UA/NSTEMI) & Planned PCI N= 13,608 ASA Double-blind CLOPIDOGREL 300 mg LD/ 75 mg MD PRASUGREL 60 mg LD/ 10 mg MD Duration of therapy: 6-15 months 1o endpoint: CV death, MI, Stroke 2o endpoint: Stent Thrombosis Safety endpoints: TIMI major bleeds, Life-threatening bleeds Wiviott SD, Antman EM et al AHJ 2006

  3. Goals of Stent Analysis STENT ANALYSIS • To compare the efficacy and safety of PRASUGREL and CLOPIDOGREL in 12,844 patients with at least one stent as part of the index procedure with respect to: • Stent Thrombosis (ARC definitions) • Ischemic Events, Bleeding • Overall and stratified by stent type received

  4. Key Efficacy, Safety EP:Stratified by Stent Type STENT ANALYSIS CVD/MI/CVA Non-CABG TIMI Major Bleeding HR 0.80 (0.69-0.93) p=0.003 HR 0.82 (0.69-0.97) p=0.02 CLOPIDOGREL PRASUGREL % of Subjects HR 1.37 (0.95-1.99) p=0.09 HR 1.19 (0.83-1.72) p=0.34 N=6461 N=5743

  5. Definite/Probable ST: Any Stent (N=12844) STENT ANALYSIS 2.35% 2.5 HR 0.48 [0.36-0.64] P<0.0001 2 CLOPIDOGREL 52% 1.5 % of Subjects 1.13% 1 PRASUGREL 1 year: 1.06 vs 2.15% HR 0.48 [0.36-0.65], P<0.0001 0.5 0 0 50 100 150 200 250 300 350 400 450 DAYS

  6. Definite/Probable ST: Any Stent (N=12844) STENT ANALYSIS EARLY ST LATE ST HR 0.41 [0.29-0.59] P<0.0001 HR 0.60 [0.37-0.97] P=0.03 CLOPIDOGREL PRASUGREL 1.56% % of Subjects 59% 0.82% 40% 0.64% 0.49% DAYS

  7. Definite/Probable ST: DES Only (N=5743) STENT ANALYSIS 2.31% HR 0.36 [0.22-0.58] P<0.0001 CLOPIDOGREL 64% % of Subjects 0.84% PRASUGREL 1 year: 0.74% vs 2.05% HR 0.35 [0.21-0.58], P<0.0001 DAYS

  8. Definite/Probable ST: BMS Only (N=6461) STENT ANALYSIS 2.41% HR 0.52 [0.35-0.77] P=0.0009 CLOPIDOGREL 48% % of Subjects 1.27% PRASUGREL 1 year: 1.22 vs 2.27% HR 0.53 [0.36-0.79], P=0.0014 DAYS

  9. Balance of Efficacy and Safety (Stented Population) STENT ANALYSIS Stent Thrombosis CVD/MI/CVA w/o ST Events per 1000 patients treated

  10. Conclusions/Implications STENT ANALYSIS • Stent Thrombosis is a rare, but devastating complication of PCI associated with a high mortality. Efforts to reduce ST have focused on compliance w/ and duration of ASA/clopidogrel • Our data indicate that an agent w/ more rapid, consistent, and greater inhibition of platelet aggregation (prasugrel) results in major reductions in ST regardless of stent type, both early and late, and across a broad array of clinical and procedural characteristics

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