Yaling Han1, Bo Xu2, Kai Xu2, Changdong Guan2, Quanmin Jing2, Qiangsun Zheng2, Xueqi Li2, Xianxian Zhao2, Haichang Wang2, Xuezhong Zhao2, Xiaoyan Li2, Pengfei Yu2, Hongyun Zang2, Zhifang Wang2, Xuebin Cao2, Jun Zhang2, Wenyue Pang2, Jing Li2, Yuejin Yang2, George D Dangas2. 1. From the Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China (Y.H., K.X., Q.J., J.L.); Catheterization Laboratory, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China (B.X., C.G.); Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China (Y.Y.); Department of Cardiology, Affiliated Tangdu Hospital of the Fourth Military Medical University, Xi'an, China (Q.Z.); Department of Cardiology, Fourth Affiliated Hospital of Haerbin Medical University, Haerbin, China (Xueqi Li); Department of Cardiology, Affiliated Changhai Hospital of the Second Military Medical University, Shanghai, China (Xianxian Zhao); Department of Cardiology, Affiliated Xijing Hospital of the Fourth Military Medical University, Xi'an, China (H.W.); Department of Cardiology, Jilin University First Hospital, Changchun, China (Xuezhong Zhao); Department of Cardiology, General Hospital of Jinan Military Region, Jinan, China (Xiaoyan Li); Department of Cardiology, Pingdu People's Hospital, Pingdu, China (P.Y.); Department of Cardiology, NO. 463 Hospital of PLA, Shenyang, China (H.Z.); Department of Cardiology, Xinxiang Central Hospital, Xinxiang, China (Z.W.); Department of Cardiology, NO. 252 Hospital of PLA, Baoding, China (X.C.); Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China (J.Z.); Department of Cardiology, Shengjing Hospital, Shenyang, China (W.P.); and The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Mount Sinai Medical Center, New York (G.D.D.). hanyalingnh@163.com. 2. From the Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China (Y.H., K.X., Q.J., J.L.); Catheterization Laboratory, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China (B.X., C.G.); Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China (Y.Y.); Department of Cardiology, Affiliated Tangdu Hospital of the Fourth Military Medical University, Xi'an, China (Q.Z.); Department of Cardiology, Fourth Affiliated Hospital of Haerbin Medical University, Haerbin, China (Xueqi Li); Department of Cardiology, Affiliated Changhai Hospital of the Second Military Medical University, Shanghai, China (Xianxian Zhao); Department of Cardiology, Affiliated Xijing Hospital of the Fourth Military Medical University, Xi'an, China (H.W.); Department of Cardiology, Jilin University First Hospital, Changchun, China (Xuezhong Zhao); Department of Cardiology, General Hospital of Jinan Military Region, Jinan, China (Xiaoyan Li); Department of Cardiology, Pingdu People's Hospital, Pingdu, China (P.Y.); Department of Cardiology, NO. 463 Hospital of PLA, Shenyang, China (H.Z.); Department of Cardiology, Xinxiang Central Hospital, Xinxiang, China (Z.W.); Department of Cardiology, NO. 252 Hospital of PLA, Baoding, China (X.C.); Department of Cardiology, Cangzhou Central Hospital, Cangzhou, China (J.Z.); Department of Cardiology, Shengjing Hospital, Shenyang, China (W.P.); and The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Mount Sinai Medical Center, New York (G.D.D.).
Abstract
BACKGROUND: There are no reports on a large-scale randomized trial exploring optimal dual antiplatelet therapy (DAPT) duration after biodegradable polymer sirolimus-eluting stent implantation. We sought to report the outcomes of a randomized substudy of the prospective Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary Revascularization (I-LOVE-IT 2) trial. METHODS AND RESULTS: In the prospective noninferiority randomized I-LOVE-IT 2 trial, 1829 patients allocated to the biodegradable polymer sirolimus-eluting stent group were also randomized to receive either 6-month (n=909) or 12-month DAPT (n=920). The primary end points of this noninferiority substudy were 12-month target lesion failure (composite of cardiac death, target vessel myocardial infarction or clinically indicated target lesion revascularization), and the major secondary end points were 12-month net adverse clinical and cerebral events (composite of all-cause death, all myocardial infarction, stroke, or major bleeding [Bleeding Academic Research Consortium type ≥3]). The 12-month target lesion failure in 6-month DAPT group was comparable with the 12-month DAPT group (6.8% versus 5.9%; difference and 95% confidence interval, 0.87% [-1.37% to 3.11%], P for noninferiority=0.0065). Further follow-up at 18 months showed that incidence of target lesion failure and net adverse clinical and cerebral events were similar between the 2 groups (7.5% versus 6.3%, log-rank P=0.32; 7.8% versus 7.3%, log-rank P=0.60; respectively), as well as their individual end point components. CONCLUSIONS: This study indicated noninferiority in safety and efficacy of 6-month versus 12-month DAPT after implantation of a novel biodegradable polymer sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01681381.
RCT Entities:
BACKGROUND: There are no reports on a large-scale randomized trial exploring optimal dual antiplatelet therapy (DAPT) duration after biodegradable polymer sirolimus-eluting stent implantation. We sought to report the outcomes of a randomized substudy of the prospective Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary Revascularization (I-LOVE-IT 2) trial. METHODS AND RESULTS: In the prospective noninferiority randomized I-LOVE-IT 2 trial, 1829 patients allocated to the biodegradable polymer sirolimus-eluting stent group were also randomized to receive either 6-month (n=909) or 12-month DAPT (n=920). The primary end points of this noninferiority substudy were 12-month target lesion failure (composite of cardiac death, target vessel myocardial infarction or clinically indicated target lesion revascularization), and the major secondary end points were 12-month net adverse clinical and cerebral events (composite of all-cause death, all myocardial infarction, stroke, or major bleeding [Bleeding Academic Research Consortium type ≥3]). The 12-month target lesion failure in 6-month DAPT group was comparable with the 12-month DAPT group (6.8% versus 5.9%; difference and 95% confidence interval, 0.87% [-1.37% to 3.11%], P for noninferiority=0.0065). Further follow-up at 18 months showed that incidence of target lesion failure and net adverse clinical and cerebral events were similar between the 2 groups (7.5% versus 6.3%, log-rank P=0.32; 7.8% versus 7.3%, log-rank P=0.60; respectively), as well as their individual end point components. CONCLUSIONS: This study indicated noninferiority in safety and efficacy of 6-month versus 12-month DAPT after implantation of a novel biodegradable polymer sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01681381.
Authors: Thomas A Mavrakanas; Yiannis S Chatzizisis; Karim Gariani; Dean J Kereiakes; Giuseppe Gargiulo; Gérard Helft; Martine Gilard; Fausto Feres; Ricardo A Costa; Marie-Claude Morice; Jean-Louis Georges; Marco Valgimigli; Deepak L Bhatt; Laura Mauri; David M Charytan Journal: Clin J Am Soc Nephrol Date: 2019-04-22 Impact factor: 8.237