• Lorenz Räber, Henning Kelbæk, Masanori Taniwaki, Miodrag Ostojic, Dik Heg, Andreas Baumbach, Clemens von Birgelen, Marco Roffi, David Tüller, Thomas Engstrøm, Aris Moschovitis, Giovanni Pedrazzini, Peter Wenaweser, Ran Kornowski, Klaus Weber, Thomas F Lüscher, Christian M Matter, Bernhard Meier, Peter Jüni, Stephan Windecker, and COMFORTABLE AMI Trial Investigators.
• 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.).
• Circ Cardiovasc Interv. 2014 Jun 1;7(3):355-64.

BackgroundThis 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 ResultsA 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).ConclusionsAmong 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 Urlhttp://www.clinicaltrials.gov. Unique identifier: NTC00962416.© 2014 American Heart Association, Inc.

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