• JAMA · Aug 2012

    Randomized Controlled Trial Multicenter Study Comparative Study

    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 Kelbæk, Miodrag Ostojic, Miodrag Ostoijc, Andreas Baumbach, Dik Heg, David Tüller, Clemens von Birgelen, Marco Roffi, Aris Moschovitis, Ahmed A Khattab, Peter Wenaweser, Robert Bonvin... more i, Giovanni Pedrazzini, Ran Kornowski, Klaus Weber, Sven Trelle, Thomas F Lüscher, Masanori Taniwaki, Christian M Matter, Bernhard Meier, Peter Jüni, Stephan Windecker, and COMFORTABLE AMI Trial Investigators. less
    • Department of Cardiology, Bern University Hospital, Bern, Switzerland.
    • JAMA. 2012 Aug 22;308(8):777-87.

    ContextThe 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).ObjectiveTo compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI.Design, Setting, And PatientsA 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.InterventionPatients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582).Main Outcome MeasuresPrimary 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.ResultsMajor 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.ConclusionCompared 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.Trial Registrationclinicaltrials.gov Identifier: NCT00962416.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        

    hide…

What will the 'Medical Journal of You' look like?

Start your free 21 day trial now.

We guarantee your privacy. Your email address will not be shared.