Biolimus-eluting stents significantly reduced the composite of cardiac death, target-vessel MI, and target lesion revascularization compared to bare-metal stents at 2 years (HR 0.48; 95% CI 0.31-0.72; P<0.001).
RCT (n=1,161)
Yes
Does biolimus-eluting stent with biodegradable polymer reduce the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization compared to bare-metal stents in patients with STEMI undergoing primary PCI?
Biolimus-eluting stents with biodegradable polymer significantly reduce long-term cardiovascular events compared to bare-metal stents in patients with STEMI undergoing primary PCI.
Effect estimate: HR 0.48 (95% CI 0.31-0.72)
Absolute Event Rate: 5.8% vs 11.9%
p-value: p=< 0.001
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.
Räber et al. (Wed,) conducted a rct in Acute ST-Elevation Myocardial Infarction (n=1,161). Biolimus-eluting stent (BES) with biodegradable polymer vs. Bare-metal stents (BMS) was evaluated on Cardiac death, target-vessel myocardial infarction, and target lesion revascularization (HR 0.48, 95% CI 0.31-0.72, p=< 0.001). Biolimus-eluting stents significantly reduced the composite of cardiac death, target-vessel MI, and target lesion revascularization compared to bare-metal stents at 2 years (HR 0.48; 95% CI 0.31-0.72; P<0.001).