Effect of Biolimus-Eluting Stents With Biodegradable Polymer vs Bare-Metal Stents on Cardiovascular Events Among Patients With Acute Myocardial Infarction: The COMFORTABLE AMI Randomized Trial

Lorenz Räber, Henning Kelbaek, Miodrag Ostojic, Andreas Baumbach, Dik Heg, David Tüller, Clemens von Birgelen, Marco Roffi, Aris Moschovitis, Ahmed A. Khattab, Peter Wenaweser, Robert Bonvini, Giovanni Pedrazzini, Ran Kornowski, Klaus Weber, Sven Trelle, Thomas F. Lüscher, Masanori Taniwaki, Christian M. Matter, Bernard MeierPeter Jüni, Stephan Windecker

Research output: Contribution to journalArticleAcademicpeer-review

221 Citations (Scopus)

Abstract

Context: The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

Objective To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI.

Design, Setting, and Patients: A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months.

Intervention: Patients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582).

Main Outcome Measures: Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel–related reinfarction, and ischemia-driven target-lesion revascularization at 1 year.

Results: Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P = .004). The difference was driven by a lower risk of target vessel–related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P = .01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P < .001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P = .53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P = .10) treated with bare-metal stents.

Conclusion: Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI.

Original languageEnglish
Pages (from-to)777-787
JournalJournal of the American Medical Association (JAMA)
Volume308
Issue number8
DOIs
Publication statusPublished - 2012

Keywords

  • METIS-290171
  • IR-82389

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