Jong-Young Lee1, Duk-Woo Park1, Young-Hak Kim1, Jung-Min Ahn1, Won-Jang Kim1, Soo-Jin Kang1, Seung-Whan Lee1, Cheol Whan Lee1, Seong-Wook Park1, Sung-Cheol Yun1, Tae-Hyun Yang1, Bong-Ki Lee1, Nae-Hee Lee1, Joo-Young Yang1, Won-Yong Shin1, Hun Sik Park1, Kee-Sik Kim1, Seung Ho Hur1, Sung Yun Lee1, Jong-Seon Park1, Yun Seok Choi1, Seung Uk Lee1, Sung-Ho Her1, Seung-Jung Park2. 1. From the Department of Cardiology (J.-Y. L., D.-W.P., Y.-H.K., J.-M.A., W.-J.K., S.-J.K., S.-W.L., C.W.L., S.-W.P., S.-J.P.) and Division of Biostatistics, Center for Medical Research and Information (S.-C.Y.), University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea; Department of Internal Medicine, Inje University Pusan Paik Hospital, Pusan, Korea (T.-H.Y.); Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea (B.-K.L.); Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea (N.-H.L.); Department of Internal Medicine, National Health Insurance Corporation Ilsan Hospital, Goyang, Korea (J.-Y.Y.); Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, Korea (W.-Y.S.); Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea (H.S.P.); Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea (K.-S.K.); Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea (S.H.H.); Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea (S.Y.L.); Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea (J.-S.P.); Department of Internal Medicine, The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, Korea (Y.S.C.); Department of Internal Medicine, Kwangju Christian Hospital, Kwangju, Korea (S.U.L.); and Department of Internal Medicine, The Catholic University of Korea, Daejeon St. Mary's Hospital, Daejeon, Korea (S.-H.H.). 2. From the Department of Cardiology (J.-Y. L., D.-W.P., Y.-H.K., J.-M.A., W.-J.K., S.-J.K., S.-W.L., C.W.L., S.-W.P., S.-J.P.) and Division of Biostatistics, Center for Medical Research and Information (S.-C.Y.), University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea; Department of Internal Medicine, Inje University Pusan Paik Hospital, Pusan, Korea (T.-H.Y.); Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea (B.-K.L.); Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea (N.-H.L.); Department of Internal Medicine, National Health Insurance Corporation Ilsan Hospital, Goyang, Korea (J.-Y.Y.); Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, Korea (W.-Y.S.); Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea (H.S.P.); Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea (K.-S.K.); Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea (S.H.H.); Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea (S.Y.L.); Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea (J.-S.P.); Department of Internal Medicine, The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, Korea (Y.S.C.); Department of Internal Medicine, Kwangju Christian Hospital, Kwangju, Korea (S.U.L.); and Department of Internal Medicine, The Catholic University of Korea, Daejeon St. Mary's Hospital, Daejeon, Korea (S.-H.H.). sjpark@amc.seoul.kr.
Abstract
BACKGROUND: Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease. METHODS AND RESULTS: This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94). CONCLUSIONS:BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186120.
RCT Entities:
BACKGROUND: Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease. METHODS AND RESULTS: This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinumchromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94). CONCLUSIONS:BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186120.
Authors: Abhilash Akinapelli; Jack P Chen; Kristine Roy; Joseph Donnelly; Keith Dawkins; Barbara Huibregtse; Dongming Hou Journal: Curr Cardiol Rev Date: 2017