Ticagrelor with or without Aspirin in High-Risk Patients after PCI.

Published

Journal Article

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. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).

Full Text

Duke Authors

Cited Authors

  • Mehran, R; Baber, U; Sharma, SK; Cohen, DJ; Angiolillo, DJ; Briguori, C; Cha, JY; Collier, T; Dangas, G; Dudek, D; D┼żavík, V; Escaned, J; Gil, R; Gurbel, P; Hamm, CW; Henry, T; Huber, K; Kastrati, A; Kaul, U; Kornowski, R; Krucoff, M; Kunadian, V; Marx, SO; Mehta, SR; Moliterno, D; Ohman, EM; Oldroyd, K; Sardella, G; Sartori, S; Shlofmitz, R; Steg, PG; Weisz, G; Witzenbichler, B; Han, Y-L; Pocock, S; Gibson, CM

Published Date

  • November 21, 2019

Published In

Volume / Issue

  • 381 / 21

Start / End Page

  • 2032 - 2042

PubMed ID

  • 31556978

Pubmed Central ID

  • 31556978

Electronic International Standard Serial Number (EISSN)

  • 1533-4406

Digital Object Identifier (DOI)

  • 10.1056/NEJMoa1908419

Language

  • eng

Conference Location

  • United States