Abstract 17274: One-Year Clinical Outcomes With Biodegradable Polymer Biolimus-Eluting Stent in Patients With Diabetes Mellitus: Comparison With Durable Polymer Everolimus-Eluting Stent
Background: Recent pivotal studies have shown that biodegradable polymer biolimus-eluting stent (BES) is as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent (EES) with a durable biocompatible polymer. However, the effectiveness of BES in a real-world setting of diabetic patients is currently unclear.
Methods: We enrolled 1275 consecutive patients with the NOBORI BES, 570 (44.7%) of whom had diabetes mellitus (DM). As a historical control group, a total of 1044 consecutive patients with the XIENCE/PROMUS EES between February 2011 and April 2012 were enrolled, 465 (44.5%) of whom had DM. The primary endpoint was the rate of major adverse cardiovascular events (MACE), defined as a composite of cardiac death, myocardial infarction, definite stent thrombosis, clinically driven target revasculization (TLR) at 1-year.
Results: Baseline characteristics were similar between the BES and EES groups. Patients with insulin dependent and multivessel coronary disease were similar between the 2 groups (21.5% vs. 19.8%, P=0.99; 34.3% vs. 28.4%, P=0.20, respectively). At 1-year, the incidence of MACE was not significantly different between the BES and EES group (8.0% vs. 5.5%, P=0.11). Cumulative incidence of myocardial infarction, definite stent thrombosis, and clinically driven TLR were not significantly different between the 2 groups (1.3% vs. 1.3%, P=0.99; 1.1% vs. 0.9%, P=0.73; 6.8% vs. 4.9%, P=0.19, respectively). At Cox regression analysis, predictors of 1-year MACE were left ventricular ejection fraction <40%, hemodialysis, and prior coronary intervention.
Conclusions: One-year clinical outcome after biodegradable polymer BES implantation in diabetic patients is not significantly different from that after durable polymer EES. This study suggests that both BES- and EES-use are acceptable in a real-world setting of diabetic patients.
- © 2013 by American Heart Association, Inc.