Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 70, Issue 11, Pages 1368-1375Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2017.07.768
Keywords
cardiovascular death; ischemic risk; myocardial infarction; P2Y(12) inhibition; secondary prevention; stroke
Categories
Funding
- AstraZeneca
- Accumetrics
- Amgen
- Beckman Coulter
- Bristol-Myers Squibb
- CV Therapeutics
- Daiichi-Sankyo Co. Ltd.
- Eli Lilly and Co.
- GlaxoSmithKline
- Integrated Therapeutics
- MedImmune
- Merck and Co.
- Nanosphere
- Novartis Pharmaceuticals
- Nuvelo
- Ortho-Clinical Diagnostics
- Pfizer
- Roche Diagnostics
- Sanofi
- Sanofi-Synthelabo
- Siemens Medical Solutions
- Singulex
- PlaqueTec
- Actelion
- Avacta
- Bayer
- Bristol-Myers Squibb/Pfizer alliance
- Novartis
- The Medicines Company
- ThermoFisher Scientific
- Merck
- Servier
- Amarin
- Chiesi
- Eisai
- Ethicon
- Forest Laboratories
- Ironwood
- Ischemix
- Lilly
- Medtronic
- Roche
- Janssen
- Maquet
- malpractice attorneys
- Bristol-Myers Squibb/Pfizer
- Boehringer Ingelheim
- Eli Lilly
- Edwards Lifesciences
- Abbott
- AZ Company
- Beth Israel Deaconess Medical
- Brigham Women's Hospital
- Cardiovascular Research Foundation
- CCC
- Celladon
- CME Resources
- Daiichi-Sankyo
- Elsevier
- Europa
- Federation Francaise de Cardiologie
- ICAN
- INSERM
- Lead-Up
- Menarini
- Merck Sharp Dohme
- TIMI Study Group
- WebMD
- Brigham and Women's Hospital from Abbott Laboratories
- Critical Diagnostics
- Genzyme
- Gilead
- Intarcia
- Janssen Research Development
- Poxel
- Takeda
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BACKGROUND Ticagrelor reduces ischemic risk in patients with prior myocardial infarction (MI). It remains unclear whether ischemic risk and the benefits of prolonged P2Y(12) inhibition in this population remain consistent over time. OBJECTIVES The study sought to investigate the pattern of ischemic risk over time and whether the efficacy and safety of ticagrelor were similar early and late after randomization. METHODS The PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction) 54 trial randomized patients with prior MI (median 1.7 years prior) to ticagrelor 90 mg, ticagrelor 60 mg, or placebo on a background of aspirin. The rates of cardiovascular (CV) death, MI, and stroke as well as TIMI major bleeding were analyzed at yearly landmarks (years 1, 2, and 3). RESULTS A total of 21,162 patients were randomized and followed for 33 months (median), with 28% of patients >= 5 years from MI at trial conclusion. The risk of CV death, MI, or stroke in the placebo arm remained roughly constant over the trial at an similar to 3% annualized rate. The benefit of ticagrelor 60 mg was consistent at each subsequent landmark (year 1 hazard ratio [HR]: 0.82; 95% confidence interval [CI]: 0.67 to 0.99; year 2 HR: 0.90; 95% CI: 0.74 to 1.11; and year 3 HR: 0.79; 95% CI: 0.62 to 1.00). TIMI major bleeding was increased with ticagrelor 60 mg at each landmark, but with the greatest hazard in the first year (year 1 HR: 3.22; year 2 HR: 2.07; year 3 HR: 1.65). CONCLUSIONS Patients with a history of MI remain at persistent high risk for CVD, MI, and stroke as late as 5 years after MI. The efficacy of low-dose ticagrelor is consistent over time with a trend toward less excess bleeding. (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562) (J Am Coll Cardiol 2017; 70: 1368-75) (C) 2017 by the American College of Cardiology Foundation.
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