Abstract | BACKGROUND: METHODS: RESULTS: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P=0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups. CONCLUSIONS:
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Authors | Pierluigi Tricoci, Zhen Huang, Claes Held, David J Moliterno, Paul W Armstrong, Frans Van de Werf, Harvey D White, Philip E Aylward, Lars Wallentin, Edmond Chen, Yuliya Lokhnygina, Jinglan Pei, Sergio Leonardi, Tyrus L Rorick, Ann M Kilian, Lisa H K Jennings, Giuseppe Ambrosio, Christoph Bode, Angel Cequier, Jan H Cornel, Rafael Diaz, Aycan Erkan, Kurt Huber, Michael P Hudson, Lixin Jiang, J Wouter Jukema, Basil S Lewis, A Michael Lincoff, Gilles Montalescot, José Carlos Nicolau, Hisao Ogawa, Matthias Pfisterer, Juan Carlos Prieto, Witold Ruzyllo, Peter R Sinnaeve, Robert F Storey, Marco Valgimigli, David J Whellan, Petr Widimsky, John Strony, Robert A Harrington, Kenneth W Mahaffey, TRACER Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 366
Issue 1
Pg. 20-33
(Jan 05 2012)
ISSN: 1533-4406 [Electronic] United States |
PMID | 22077816
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Lactones
- Platelet Aggregation Inhibitors
- Pyridines
- Receptor, PAR-1
- vorapaxar
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Topics |
- Acute Coronary Syndrome
(drug therapy, therapy)
- Aged
- Angioplasty
- Cardiovascular Diseases
(mortality, prevention & control)
- Combined Modality Therapy
- Coronary Artery Bypass
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Hemorrhage
(chemically induced)
- Humans
- Intracranial Hemorrhages
(chemically induced)
- Kaplan-Meier Estimate
- Lactones
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Platelet Aggregation Inhibitors
(adverse effects, therapeutic use)
- Pyridines
(adverse effects, therapeutic use)
- Receptor, PAR-1
(antagonists & inhibitors)
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