Biolimus-A9-eluting BP-DES were noninferior to everolimus-eluting DP-DES for cardiac death, MI, and target-vessel revascularization at 2 years (7.6% vs 6.8%; P=0.042 for noninferiority).
RCT (n=2,291)
Yes
Does biolimus-A9-eluting biodegradable-polymer drug-eluting stents reduce combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization in patients with acute or stable coronary disease needing stents ≥3.0 mm compared to everolimus-eluting durable-polymer stents or bare-metal stents?
Biodegradable-polymer biolimus-eluting stents were noninferior to durable-polymer everolimus-eluting stents and superior to bare-metal stents for large vessel stenting, but did not improve long-term safety or reduce very late stent thrombosis, challenging the concept that durable polymers are the primary cause of this complication.
Effect estimate: Absolute risk difference 0.78% (95% CI -1.93 to 3.50)
Absolute Event Rate: 7.6% vs 6.8%
p-value: p=0.042 for noninferiority
BACKGROUND: Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. METHODS AND RESULTS: To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. CONCLUSIONS: In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166685.
Kaiser et al. (Thu,) conducted a rct in Acute or stable coronary disease needing stents ≥3.0 mm in diameter (n=2,291). Biolimus-A9-eluting biodegradable-polymer drug-eluting stents (BP-DES) vs. Everolimus-eluting durable-polymer drug-eluting stents (DP-DES) and bare-metal stents (BMS) was evaluated on Combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years (Absolute risk difference 0.78%, 95% CI -1.93 to 3.50, p=0.042 for noninferiority). Biolimus-A9-eluting BP-DES were noninferior to everolimus-eluting DP-DES for cardiac death, MI, and target-vessel revascularization at 2 years (7.6% vs 6.8%; P=0.042 for noninferiority).