European Heart Journal Advance Access originally published online on August 5, 2008
European Heart Journal 2008 29(20):2473-2479; doi:10.1093/eurheartj/ehn362
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Reduction in recurrent cardiovascular events with prasugrel compared with clopidogrel in patients with acute coronary syndromes from the TRITON-TIMI 38 trial
1 TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 350 Longwood Avenue, First Office Floor, Boston, MA 02115, USA
2 Eli Lilly Research Laboratories, Indianapolis, IN, USA
3 Azienda Ospedaliera S. Maria della Misericordia, Udine, Italy
4 3rd Medical Department, Cardiology and Emergency Medicine, Wilhelminenhospital, Vienna, Austria
5 Cardiology Department, Hospital Universitario La Paz, Madrid, Spain
Received 3 July 2008; revised 15 July 2008; accepted 17 July 2008; online publish-ahead-of-print 5 August 2008.
* Corresponding author. Tel: +1 617 278 0145, Fax: +1 617 734 7329, Email: eantman{at}partners.org
Aims: In the TRITON-TIMI 38 trial, greater platelet inhibition with prasugrel reduced the first occurrence of the primary endpoint (cardiovascular death, MI, or stroke) compared with clopidogrel in patients with an acute coronary syndrome (ACS) undergoing planned percutaneous coronary intervention. We hypothesized that prasugrel would reduce not only first events but also recurrent primary endpoint events and therefore total events compared with clopidogrel.
Methods and results: Poisson regression analysis was performed to compare the number of occurrences of the primary endpoint between prasugrel and clopidogrel in TRITON-TIMI 38. Landmark analytic methods were used to evaluate the risk of a recurrent primary endpoint event following an initial non-fatal endpoint event. Among patients with an initial non-fatal event, second events were significantly reduced with prasugrel compared to clopidogrel (10.8 vs. 15.4%, HR 0.65, 95% CI 0.46–0.92; P = 0.016), as was CV death following the non-fatal event (3.7 vs. 7.1%, HR 0.46, 95% CI 0.25–0.82; P = 0.008). Overall there was a reduction of 195 total primary efficacy events with prasugrel vs. clopidogrel (rate ratio 0.79, 95% CI 0.71–0.87; P < 0.001). Recurrent bleeding events occurred infrequently (TIMI major non-CABG bleeds: four with prasugrel and two with clopidogrel). Study drug discontinuation was frequent following the initial major bleeding event (42% of patients discontinued study drug).
Conclusion: While standard statistical analytic techniques for clinical trials censor patients who experience a component of the primary composite endpoint, total cardiovascular events remain important to both patients and clinicians. Prasugrel, a more potent anti-platelet agent, reduced both first and subsequent cardiovascular events compared with clopidogrel in patients with ACS.
Key Words: Acute coronary syndrome • Percutaneous coronary intervention • Prasugrel • Clopidogrel
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