Abstract
There are limited data about clinical outcomes of biodegradable polymer biolimus-eluting BioMatrix stents (BP-BES) and durable polymer everolimus-eluting Xience stents (DP-EES) in real world practice. We sought to compare the clinical outcomes of BP-BES and DP-EES in real world cohorts of patients undergoing percutaneous coronary intervention. A prospective multicenter registry enrolled 999 patients treated with BP-BES and 1,000 patients treated with DP-EES. The primary outcome was target lesion failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization. Definite or probable stent thrombosis was also compared in total and propensity score-matched cohorts. The median follow-up duration was 24 months, and mean age was 65 years (interquartile range, 56–72 years). Patients receiving BP-BES had a lower prevalence of acute coronary syndrome, prior myocardial infarction, multi-vessel disease, bifurcation lesions, and left anterior descending artery lesions than those receiving DP-EES. After propensity score matching (692 pairs), target lesion failure occurred in 22 patients receiving BP-BES and in 25 patients receiving DP-EES (3.2% versus 3.6%; adjusted hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.53 to 1.60; p = 0.77). The risk of definite or probable stent thrombosis did not differ between the 2 groups (0.4% versus 0.4%; adjusted HR, 1.03; 95% CI, 0.21 to 4.98; p = 0.97). The results were consistent across various subgroups. In the propensity score-matched analysis of real world cohorts, BP-BES showed similar clinical outcomes compared to DP-EES. We need to investigate about whether differences in clinical outcome emerge during long-term follow-up.
Highlights
Drug-eluting stents (DES) consisting of a metal platform and a polymer coating with the release of antiproliferative drugs had reduced restenosis compared with bare metal stents [1,2]
Durable polymer was potentially associated with delayed healing, allergic reaction, and chronic inflammation that could lead to impaired endothelialization of the stent strut and positive vessel remodeling, and increase the risk of stent thrombosis [6,7]
Recent studies showed that biodegradable polymer biolimus-eluting stent (BP-BES) had a safety benefit compared with first-generation DES in terms of a reduction in very late stent thrombosis [9]
Summary
Drug-eluting stents (DES) consisting of a metal platform and a polymer coating with the release of antiproliferative drugs had reduced restenosis compared with bare metal stents [1,2]. First-generation DES such as sirolimus- or paclitaxel-eluting stent increased the concern about late stent thrombosis [3,4,5]. Newer generation durable polymer-coated DES was developed to improve polymer biocompatibility, and biocompatible durable polymer everolimus-eluting stent (DP-EES) is regarded due to safety and efficacy profile as the gold standard [8]. Newer generation DES using biodegradable polymer was developed to overcome the long-term adverse vascular reaction related to the durable polymer. Recent studies showed that biodegradable polymer biolimus-eluting stent (BP-BES) had a safety benefit compared with first-generation DES in terms of a reduction in very late stent thrombosis [9]. BP-BES showed similar safety and efficacy in comparison to DP-EES [10,11]. We sought to compare the safety and efficacy of BP-BES and DP-EES in an “all-comer” registry
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