Abstract 20483: Outcomes in Stable Patients With Prior Atherothrombosis Receiving Vorapaxar Who Present With a New Acute Coronary Syndrome: Insights From the TRA2P-TIMI 50 Trial
BACKGROUND: Vorapaxar is a PAR-1 antagonist approved in the United States for reduction of ischemic events in stable patients with history of MI or PAD and no history of stroke or TIA (CVD). Vorapaxar is not recommended for initiation in the acute phase of acute coronary syndrome (ACS) because of an unfavorable balance of bleeding vs. efficacy. We investigated outcomes in stable patients who experienced a new ACS event while receiving vorapaxar vs placebo.
METHODS: TRA2°P-TIMI 50 was a randomized, double-blind, placebo-controlled trial of vorapaxar for secondary prevention including 20,170 pts with MI or PAD and no CVD (approval population). The protocol recommended that study drug be continued through all ischemic events and procedures. We evaluated short term rates of ischemic events and bleeding among pts who developed a new ACS (MI or unstable angina) during follow up.
RESULTS: During a median follow up of 31 months, 799 patients randomized to vorapaxar and 913 to placebo had a new ACS event with 87% on vorapaxar and 86% on placebo continuing on therapy through the event. In a landmark analysis through 7 days after ACS, vorapaxar was associated with lower rates of CVD, MI, or stroke and similar rates of severe bleeding compared to placebo (Figure). GUSTO moderate or severe bleeding was numerically increased with vorapaxar (HR 1.36, 95% CI 0.68 - 2.71, p=0.38). Findings with vorapaxar were consistent at 30 days after ACS for CVD/MI/Stroke (HR 0.81, 95% CI 0.54 - 1.21, p=0.30), GUSTO severe bleeding (HR 1.01, 95% CI 0.36 - 2.78, p=0.99), and ICH (0 with vorapaxar vs. 1 with placebo).
CONCLUSIONS: In stable patients with atherosclerotic vascular disease who experience an ACS event while receiving vorapaxar, continuing therapy was associated with favorable efficacy without excess severe bleeding during the period of acute ACS management.
Character Count: 1573 + 1 figure (250) = 1823 (limit 1,950)
Author Disclosures: M.P. Bonaca: Research Grant; Significant; The TIMI Study Group has received significant research grant support from Accumetrics, Amgen, AstraZeneca, Beckman Coulter, Bristol-Myers Squibb, CV Therapeutics, Daiichi Sankyo Co Ltd, The TIMI Study Group has received significant research grant support Eli Lilly and Co, GlaxoSmithKline, Integrated Therapeutics, Merck and Co, Nanosphere, Novartis Pharmaceuticals, Nuvelo, The TIMI Study Group has received significant research grant support from Ortho-Clinical Diagnostics, Pfizer, Roche Diagnostics, Sanofi-Aventis, Sanofi-Synthelabo, Siemens Medical Solutions, The TIMI Study Group has received significant research grant support from Singulex. Consultant/Advisory Board; Modest; Roche diagnostics, AstraZeneca, Merck and Co. B.M. Scirica: Research Grant; Significant; Same TIMI Study Group research grants as listed for Marc P Bonaca. E. Braunwald: Research Grant; Significant; TIMI Research Grant Support as described for Dr. Bonaca. S.A. Murphy: Research Grant; Significant; TIMI Research Grant Support as described for Dr. Bonaca. D.A. Morrow: Research Grant; Significant; Abbott, Amgen, AstraZeneca, Beckman Coulter, BG Medicine, BRAHMS, Bristol-Myers Squibb, Critical Diagnostics, CV Therapeutics, Daiichi Sankyo Co Ltd, Eli Lilly and Co, GlaxoSmithKline, Johnson & Johnson, Merck and Co, Novartis Pharmaceuticals, Roche Diagnostics, Sanofi-Aventis, Singulex, and Takeda. Consultant/Advisory Board; Modest; Abbott Laboratories, DiaDexus, Eli Lilly, Gilead, Instrumentation Laboratory, Konica Minolta, Johnson & Johnson, Merck, Roche Diagnostics, and Servier..
- © 2014 by American Heart Association, Inc.