TY - JOUR
T1 - Ticagrelor with or without aspirin in high-risk patients after PCI
AU - Mehran, R.
AU - Baber, U.
AU - Sharma, S. K.
AU - Cohen, D. J.
AU - Angiolillo, D. J.
AU - Briguori, C.
AU - Cha, J. Y.
AU - Collier, T.
AU - Dangas, G.
AU - Dudek, D.
AU - Džavík, V.
AU - Escaned, J.
AU - Gil, R.
AU - Gurbel, P.
AU - Hamm, C. W.
AU - Henry, T.
AU - Huber, K.
AU - Kastrati, A.
AU - Kaul, U.
AU - Kornowski, R.
AU - Krucoff, M.
AU - Kunadian, V.
AU - Marx, S. O.
AU - Mehta, S. R.
AU - Moliterno, D.
AU - Ohman, E. M.
AU - Oldroyd, K.
AU - Sardella, G.
AU - Sartori, S.
AU - Shlofmitz, R.
AU - Steg, P. G.
AU - Weisz, G.
AU - Witzenbichler, B.
AU - Han, Y.
AU - Pocock, S.
AU - Gibson, C. M.
N1 - Publisher Copyright:
© 2019 Massachusetts Medical Society.
PY - 2019/11/21
Y1 - 2019/11/21
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85074522195&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1908419
DO - 10.1056/NEJMoa1908419
M3 - Article
C2 - 31556978
AN - SCOPUS:85074522195
SN - 0028-4793
VL - 381
SP - 2032
EP - 2042
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 21
ER -