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. Introduction First-generation (1G) drug-eluting stents (DES) are associated with remarkable reduction of neointimal proliferation and favorable clinical outcomes, 1 yet raised concerns regarding stent thrombosis (ST), especially at late or very late phases.2 Polymer, a key component of DES platforms, is a risk factor for ST occurrence. In 1G-DES, durable polymer (DP) controls drug release kinetics, while potentially causing local inflammation and hypersensitivity, 3 which fueled the use of more biocompatible DPs (such as fluorocopolymer) or biodegradable polymers (BP) in second-generation (2G) or third-generation DES. 4 A recent network metaanalysis showed a lower incidence of ST with 2G-DP-DES, 5 and in the LEADERS (Limus Eluted From a Durable Versus Erodable Stent Coating) trial, BP-DES yielded a lower 5-year risk of ST relative to 1G-DP-DES. 4 However, it remains undefined how BP-DES and 2G-DP-DES compare in terms of the risk of polymer-related ST. Acute myocardial infarction (AMI) is reported to be associated with risk of ST after stent implantation, 2 and patients with AMI are frequently treated with DES. The purpose of this study, therefore, was to evaluate the safety and efficacy of BP-DES compared with 2G-DP-DES in the higher ST risk setting of AMI.

A propensity score‐matched comparison of biodegradable polymer vs second‐generation durable polymer drug‐eluting stents in a real‐world population

“…Conversely, in a real‐world setting, only symptomatic patients could be identified and referred for revascularization. The safety and efficacy of BP‐DES and DP‐DES were similar to that reported in a Korean registry, which reported comparable clinical outcomes at one‐year and two‐year follow‐up.…”

“…Recent evidence derived from systematic review and meta‐analyses of randomized controlled trials showed that BP‐DES have similar efficacy and safety profiles compared with DP‐DES in terms of ST, target vessel revascularization, MI, and death . However, there is a paucity of data comparing BP‐DES and DP‐DES in a real‐world setting where patients in clinical practice often have more complex lesions and other comorbidities . Given that protocol‐driven angiographic follow‐up could inflate the incidence of target lesion revascularization; observational studies may give a more realistic indication of outcomes and complications.…”

Adverse cardiovascular events associated with biodegradable polymer drug-eluting stents and durable polymer everolimus-eluting stents

“…[21] However, a significantly lower risk of late ST was observed in the BP-DES group when compared to DP-DES. Note that among 8 trials which were included, 3 trials involved DP-EES.…”

“…In addition, the meta-analysis of randomized trials comparing the effectiveness and safety between BP-DES and DP-DES showed no significant reduction in MACEs with the use of BP-DES. [ 21 ] However, a significantly lower risk of late ST was observed in the BP-DES group when compared to DP-DES. Note that among 8 trials which were included, 3 trials involved DP-EES.…”

Clinical outcomes of bioabsorbable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: two-year follow-up of the DESSOLVE III trial

“…Since cardiac death includes unexplained death, it would be difficult to elaborate further on the exact cause of the differences in cardiac death. The differences were less in vascular death (0.6% [4] vs 0.9% [6], in the MiStent and XIENCE arms, respectively [p=0.53]) and non-cardiovascular death (1.9% [13] vs 1.2% [8], in the MiStent and XIENCE arms, respectively [p=0.27]).…”