Ticagrelor with or without aspirin in high-risk patients after PCI

R. Mehran, U. Baber, S. K. Sharma, D. J. Cohen, D. J. Angiolillo, C. Briguori, J. Y. Cha, T. Collier, G. Dangas, D. Dudek, V. Džavík, J. Escaned, R. Gil, P. Gurbel, C. W. Hamm, T. Henry, K. Huber, A. Kastrati, U. Kaul, R. KornowskiM. Krucoff, V. Kunadian, S. O. Marx, S. R. Mehta, D. Moliterno, E. M. Ohman, K. Oldroyd, G. Sardella, S. Sartori, R. Shlofmitz, P. G. Steg, G. Weisz, B. Witzenbichler, Y. Han, S. Pocock, C. M. Gibson

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651 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)2032-2042
Number of pages11
JournalNew England Journal of Medicine
Volume381
Issue number21
DOIs
StatePublished - 21 Nov 2019
Externally publishedYes

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