Lorenz Räber1, Henning Kelbæk1, Masanori Taniwaki1, Miodrag Ostojic1, Dik Heg1, Andreas Baumbach1, Clemens von Birgelen1, Marco Roffi1, David Tüller1, Thomas Engstrøm1, Aris Moschovitis1, Giovanni Pedrazzini1, Peter Wenaweser1, Ran Kornowski1, Klaus Weber1, Thomas F Lüscher1, Christian M Matter1, Bernhard Meier1, Peter Jüni1, Stephan Windecker2. 1. From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (L.R., M.T., A.M., P.W., B.M., S.W.); Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark (H.K., T.E.); Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia (M.O.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Bristol Heart Institute, Bristol, United Kingdom (A.B.); Thoraxcenter Twente and Twente University, Enschede, The Netherlands (C.v.B.); Division of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Cardiocentro, Lugano, Switzerland (G.P.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Tel Aviv University, Tel Aviv, Israel (R.K.); Kantonsspital Winterthur, Winterthur, Switzerland (K.W.); Department of Cardiology, University Hospital Zurich, Zurich, Switzerland (T.F.L., C.M.M.); and Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland (P.J., S.W.). 2. From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (L.R., M.T., A.M., P.W., B.M., S.W.); Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark (H.K., T.E.); Department of Cardiology, Clinical Center of Serbia, Belgrade, Serbia (M.O.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (D.H., P.J.); Bristol Heart Institute, Bristol, United Kingdom (A.B.); Thoraxcenter Twente and Twente University, Enschede, The Netherlands (C.v.B.); Division of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Cardiocentro, Lugano, Switzerland (G.P.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Tel Aviv University, Tel Aviv, Israel (R.K.); Kantonsspital Winterthur, Winterthur, Switzerland (K.W.); Department of Cardiology, University Hospital Zurich, Zurich, Switzerland (T.F.L., C.M.M.); and Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland (P.J., S.W.). stephan.windecker@insel.ch.
Abstract
BACKGROUND: This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up. METHODS AND RESULTS:A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio = 0.48; 95% confidence interval, 0.31-0.72; P < 0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years = 0.45; 95% confidence interval, 0.20-1.00; P = 0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P < 0.001) and target-vessel reinfarction (1.3% versus 3.4%; P = 0.023). The composite of death, any reinfarction and revascularization (14.5% versus 19.3%; P = 0.03), and cardiac death or target-vessel myocardial infarction (4.2% versus 7.2%; P = 0.036) were less frequent among BES-treated patients compared with BMS-treated patients. The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 ± 7.2 in BES- and 39.6 ± 25.2 in BMS-treated lesions (P < 0.001). CONCLUSIONS: Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, BES continued to improve cardiovascular events compared with BMS beyond 1 year. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NTC00962416.
RCT Entities:
BACKGROUND: This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up. METHODS AND RESULTS: A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio = 0.48; 95% confidence interval, 0.31-0.72; P < 0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years = 0.45; 95% confidence interval, 0.20-1.00; P = 0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P < 0.001) and target-vessel reinfarction (1.3% versus 3.4%; P = 0.023). The composite of death, any reinfarction and revascularization (14.5% versus 19.3%; P = 0.03), and cardiac death or target-vessel myocardial infarction (4.2% versus 7.2%; P = 0.036) were less frequent among BES-treated patients compared with BMS-treated patients. The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 ± 7.2 in BES- and 39.6 ± 25.2 in BMS-treated lesions (P < 0.001). CONCLUSIONS: Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, BES continued to improve cardiovascular events compared with BMS beyond 1 year. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NTC00962416.
Authors: Ernest Spitzer; Martina Frei; Serge Zaugg; Susanne Hadorn; Henning Kelbaek; Miodrag Ostojic; Andreas Baumbach; David Tüller; Marco Roffi; Thomas Engstrom; Giovanni Pedrazzini; Vladan Vukcevic; Michael Magro; Ran Kornowski; Thomas F Lüscher; Clemens von Birgelen; Dik Heg; Stephan Windecker; Lorenz Räber Journal: J Am Heart Assoc Date: 2017-08-05 Impact factor: 5.501
Authors: Abhilash Akinapelli; Jack P Chen; Kristine Roy; Joseph Donnelly; Keith Dawkins; Barbara Huibregtse; Dongming Hou Journal: Curr Cardiol Rev Date: 2017
Authors: Keun Ho Park; Myung Ho Jeong; Young Joon Hong; Youngkeun Ahn; Hyun Kuk Kim; Young Yub Koh; Doo Il Kim; Sang Wook Kim; Weon Kim; Seung Woon Rha; Jay Young Rhew; Jong Seon Park; Hun Sik Park; Jang Ho Bae; Jang Whan Bae; Seok Kyu Oh; Sung Yun Lee; Seung Wook Lee; Jae Hwan Lee; Sang Yeob Lim; Jang Hyun Cho; Kwang Soo Cha; Jai Keon Chae; Seung Ho Hur; Sun Ho Hwang; Jin Yong Hwang Journal: Yonsei Med J Date: 2018-01 Impact factor: 2.759