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Ticagrelor with or without Aspirin in High-Risk Patients after PCI.
Mehran, Roxana; Baber, Usman; Sharma, Samin K; Cohen, David J; Angiolillo, Dominick J; Briguori, Carlo; Cha, Jin Y; Collier, Timothy; Dangas, George; Dudek, Dariusz; Dzavík, Vladimír; Escaned, Javier; Gil, Robert; Gurbel, Paul; Hamm, Christian W; Henry, Timothy; Huber, Kurt; Kastrati, Adnan; Kaul, Upendra; Kornowski, Ran; Krucoff, Mitchell; Kunadian, Vijay; Marx, Steven O; Mehta, Shamir R; Moliterno, David; Ohman, E Magnus; Oldroyd, Keith; Sardella, Gennaro; Sartori, Samantha; Shlofmitz, Richard; Steg, P Gabriel; Weisz, Giora; Witzenbichler, Bernhard; Han, Ya-Ling; Pocock, Stuart; Gibson, C Michael.
Afiliação
  • Mehran R; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Baber U; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Sharma SK; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Cohen DJ; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Angiolillo DJ; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Briguori C; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Cha JY; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Collier T; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Dangas G; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Dudek D; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Dzavík V; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Escaned J; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Gil R; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Gurbel P; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Hamm CW; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Henry T; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Huber K; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Kastrati A; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Kaul U; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Kornowski R; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Krucoff M; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Kunadian V; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Marx SO; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Mehta SR; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Moliterno D; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Ohman EM; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Oldroyd K; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Sardella G; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Sartori S; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Shlofmitz R; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Steg PG; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Weisz G; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Witzenbichler B; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Han YL; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Pocock S; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
  • Gibson CM; From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St
N Engl J Med ; 381(21): 2032-2042, 2019 11 21.
Article em En | MEDLINE | ID: mdl-31556978
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.).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Inibidores da Agregação Plaquetária / Aspirina / Doença das Coronárias / Intervenção Coronária Percutânea / Ticagrelor / Hemorragia Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2019 Tipo de documento: Article
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Inibidores da Agregação Plaquetária / Aspirina / Doença das Coronárias / Intervenção Coronária Percutânea / Ticagrelor / Hemorragia Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2019 Tipo de documento: Article