TY - JOUR
T1 - Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction
T2 - The comfortable AMI randomized trial
AU - Räber, Lorenz
AU - Kelbæk, Henning
AU - Ostoijc, Miodrag
AU - Baumbach, Andreas
AU - Heg, Dik
AU - Tüller, David
AU - Von Birgelen, Clemens
AU - Roffi, Marco
AU - Moschovitis, Aris
AU - Khattab, Ahmed A.
AU - Wenaweser, Peter
AU - Bonvini, Robert
AU - Pedrazzini, Giovanni
AU - Kornowski, Ran
AU - Weber, Klaus
AU - Trelle, Sven
AU - Lüscher, Thomas F.
AU - Taniwaki, Masanori
AU - Matter, Christian M.
AU - Meier, Bernhard
AU - Jüni, Peter
AU - Windecker, Stephan
PY - 2012/8/22
Y1 - 2012/8/22
N2 - 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 ischemiadriven 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. Trial Registration: clinicaltrials.gov Identifier: NCT00962416.
AB - 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 ischemiadriven 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. Trial Registration: clinicaltrials.gov Identifier: NCT00962416.
UR - http://www.scopus.com/inward/record.url?scp=84865334791&partnerID=8YFLogxK
U2 - 10.1001/jama.2012.10065
DO - 10.1001/jama.2012.10065
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C2 - 22910755
AN - SCOPUS:84865334791
SN - 0098-7484
VL - 308
SP - 777
EP - 787
JO - JAMA
JF - JAMA
IS - 8
ER -
