Two-Year Safety and Efficacy of Biodegradable Polymer Drug-Eluting Stent Versus Second-Generation Durable Polymer Drug-Eluting Stent in Patients With Acute Myocardial Infarction: Data from the Korea Acute Myocardial Infarction Registry (KAMIR)

Abstract

Background: Despite improved long-term safety of biodegradable polymer (BP) drug-eluting stents (DES) compared to first-generation durable polymer (DP) DES, data on the safety and efficacy of BP-DES compared with second-generation (2G) DP-DES in patients with acute myocardial infarction (AMI) are limited.

Hypothesis: To evaluate the safety and efficacy of BP-DES compared with 2G-DP-DES in the higher stent thrombosis (ST) risk setting of AMI.

Methods: A total of 3359 AMI patients who received either BP-DES (n = 261) or 2G-DP-DES (n = 3098) were included from the Korea Acute Myocardial Infarction Registry (KAMIR). Differences in baseline clinical and angiographic characteristics were adjusted using a 1:5 propensity score matching analysis (n = 261 for BP-DES and n = 1305 for 2G-DP-DES). The primary outcome was the incidence of major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction (re-MI), and target vessel revascularization (TVR). The rate of definite or probable ST was also investigated.

Results: In adjusted analysis, there was no significant difference between the 2 groups in baseline clinical and angiographic characteristics; 2-year MACE (10.7% and 9.9% in the BP-DES group and 2G-DP-DES group, respectively, P = 0.679); ST incidence (0.8% vs 0.9%, respectively, P = 1.0), and rates of all-cause death, re-MI, and TVR. By multivariate analysis, old age, diabetes mellitus, renal dysfunction, and left ventricular dysfunction were the independent predictors of MACE after BP-DES or 2G-DP-DES implantation.

Conclusions: BP-DES and 2G-DP-DES appear to have comparable 2-year safety and efficacy for the treatment of AMI. However, longer-term follow-up is needed.