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Randomized Controlled Trial
. 2014 Jun;7(3):355-64.
doi: 10.1161/CIRCINTERVENTIONS.113.001440. Epub 2014 May 20.

Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial

Lorenz Räber  1 , Henning Kelbæk  1 , Masanori Taniwaki  1 , Miodrag Ostojic  1 , Dik Heg  1 , Andreas Baumbach  1 , Clemens von Birgelen  1 , Marco Roffi  1 , David Tüller  1 , Thomas Engstrøm  1 , Aris Moschovitis  1 , Giovanni Pedrazzini  1 , Peter Wenaweser  1 , Ran Kornowski  1 , Klaus Weber  1 , Thomas F Lüscher  1 , Christian M Matter  1 , Bernhard Meier  1 , Peter Jüni  1 , Stephan Windecker  2 ; COMFORTABLE AMI Trial Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial

Lorenz Räber et al. Circ Cardiovasc Interv. 2014 Jun.
Free article

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.

Keywords: angiography; drug-eluting stents; myocardial infarction.

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