Cheol Whan Lee1, Jung-Min Ahn, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Young-Hak Kim, Seong-Wook Park, Seungbong Han, Sang-Gon Lee, In-Whan Seong, Seung-Woon Rha, Myung-Ho Jeong, Do-Sun Lim, Jung-Han Yoon, Seung-Ho Hur, Yun-Seok Choi, Joo-Young Yang, Nae-Hee Lee, Hyun-Sook Kim, Bong-Ki Lee, Kee-Sik Kim, Seung-Uk Lee, Jei-Keon Chae, Sang-Sig Cheong, Il-Woo Suh, Hun-Sik Park, Deuk-Young Nah, Doo-Soo Jeon, Ki-Bae Seung, Keun Lee, Jae-Sik Jang, Seung-Jung Park. 1. From The Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul (C.W.L., J.-M.A., D.-W.P., S.-J.K., S.-W.L., Y.-H.K., S.-W.P., S.-J.P.); Division of Biostatistics, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul (S.H.); Ulsan University Hospital, Ulsan (S.-G.L.); Chungnam National University Hospital, Daejeon (I.-W. Seong); Korea University Guro Hospitals, Seoul (S.-W.R.); Chonnam National University Hospital, Gwangju (M.-H.J.); Korea University Anam Hospitals, Seoul (D.-S.L.); Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wonju (J.-H.Y.); Keimyung University Dongsan Medical Center, Daegu (S.-H.H.); Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul (Y.-S.C.); National Health Insurance Corp, Ilsan Hospital, Ilsan (J.-Y.Y.); Soon Chun Hyang University Hospital Bucheon, Bucheon (N.-H.L.); Hallym University Sacred Heart Hospital, Anyang (H.-S.K.); Kangwon National University Hospital, Chuncheon (B.-K.L.); Daegu Catholic University Medical Center, Daegu (K.-S.K.); Kwangju Christian Hospital, Kwangju (S.-U.L.); Chonbuk National University Hospital, Jeonju (J.-K.C.); GangNeung Asan Medical Center, Gangneung (S.-S.C.); Sam Anyang Hospital, Anyang (I.-W. Suh); Kyungpook National University Hospital, Daegu (H.-S.P.); Dongguk University Gyeongju Hospital, Gyeongju (D.-Y.N.); Catholic University of Korea, Incheon St. Mary's Hospital, Incheon (D.-S.J.); Catholic University of Korea, Seoul St. Mary's Hospital, Seoul (K.-B.S.); Veterans Hospital Service Medical Center, Seoul (K.L.); and Inje University College of Medicine, Busan Paik Hospital, Busan (J.-S.J.), South Korea.
Abstract
BACKGROUND: The risks and benefits of long-term dual antiplatelet therapy remain unclear. METHODS AND RESULTS: This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20). CONCLUSIONS: Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versusaspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186146.
RCT Entities:
BACKGROUND: The risks and benefits of long-term dual antiplatelet therapy remain unclear. METHODS AND RESULTS: This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20). CONCLUSIONS: Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186146.