Duk-Woo Park1, Osung Kwon2, Jae-Sik Jang3, Sung-Cheol Yun4, Hanbit Park1, Do-Yoon Kang1, Jung-Min Ahn1, Pil Hyung Lee1, Seung-Whan Lee1, Seong-Wook Park1, Si Wan Choi5, Sang-Gon Lee6, Hyuck-Jun Yoon7, Taehoon Ahn8, Moo Hyun Kim9, Deuk Young Nah10, Sung Yun Lee11, Jei Keon Chae12, Seung-Jung Park1. 1. Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.). 2. Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Korea (O.K.). 3. Inje University Busan Paik Hospital, Busan, Korea (J.S.J.). 4. Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (S.C.Y.). 5. Chungnam National University Hospital, Daejeon, Korea (S.W.C.). 6. Ulsan University Hospital, Ulsan, Korea (S.G.L.). 7. Keimyung University Dongsan Medical Center, Daegu, Korea (H.J.Y.). 8. Gachon University Gil Hospital, Incheon, Korea (T.A.). 9. Dong-A University Medical Center, Busan, Korea (M.H.K.). 10. Dongguk University Gyeongju Hospital, Gyeongju, Korea (D.Y.N.). 11. Inje University Ilsan Paik Hospital, Ilsan, Korea (S.Y.L.). 12. Chonbuk National University Hospital, Jeonju, Korea (J.K.C.).
Abstract
BACKGROUND: Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS: In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS: At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P=0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P=0.04) and fatal bleeding (1% [4/400] vs 0%, P=0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P=0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS: In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963.
RCT Entities:
BACKGROUND: Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS: In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS: At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P=0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P=0.04) and fatal bleeding (1% [4/400] vs 0%, P=0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P=0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS: In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963.
Authors: Seng Chan You; Yeunsook Rho; Behnood Bikdeli; Jiwoo Kim; Anastasios Siapos; James Weaver; Ajit Londhe; Jaehyeong Cho; Jimyung Park; Martijn Schuemie; Marc A Suchard; David Madigan; George Hripcsak; Aakriti Gupta; Christian G Reich; Patrick B Ryan; Rae Woong Park; Harlan M Krumholz Journal: JAMA Date: 2020-10-27 Impact factor: 56.272
Authors: Ioannis T Farmakis; Stefanos Zafeiropoulos; Ioannis Doundoulakis; Areti Pagiantza; Efstratios Karagiannidis; Dimitrios V Moysidis; Nikolaos Stalikas; George Kassimis; Lampros K Michalis; Haralambos Karvounis; George Giannakoulas Journal: Open Heart Date: 2022-04