BACKGROUND Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference,-0.06 percentage points; 95% CI,-0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke.
|Number of pages||11|
|Journal||New England Journal of Medicine|
|State||Published - Nov 21 2019|
Bibliographical noteFunding Information:
Supported by AstraZeneca.
We conducted this randomized, placebo-controlled trial in 187 sites across 11 countries. The trial rationale and design have been described previ- ously.17 The Icahn School of Medicine at Mount Sinai designed and sponsored the trial, which was supported by an investigator-initiated grant from AstraZeneca. The executive and steering committees were responsible for trial conduct, the integrity of the data analysis, and the reporting of results. National regulatory agencies and institutional review boards or ethics committees of participating centers approved the trial protocol, which is available with the full text of this article at NEJM.org. An independent data and safety monitoring board provided external oversight to ensure the safety of the trial participants. All the authors vouch for the adherence of the trial to the protocol, and the first, second, and last authors vouch for the accuracy and completeness of the data. The committee members and participating investigators are listed in Table S1 in the Supplementary Appendix, available at NEJM.org. AstraZeneca provided financial support and supplied ticagrelor for the trial but had no role in the design, collection, analysis, or interpretation of the data, in the preparation of the manuscript, or in the decision to submit the manuscript for publication.
© 2019 Massachusetts Medical Society.
ASJC Scopus subject areas
- Medicine (all)