Biolimus-Eluting Stents With Biodegradable Polymer Versus Bare-Metal Stents in Acute Myocardial Infarction

Lorenz Räber, Henning Kelbaek, Masanori Taniwaki, Miodrag C. 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, Bernard Meier, Peter Jüni, Stephan Windecker

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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 1061 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

Original languageEnglish
Pages (from-to)355-364
JournalCirculation : cardiovascular interventions
Publication statusPublished - 20 May 2014


  • METIS-307087
  • IR-93180


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