Ten-Year Clinical Outcomes of Biodegradable Versus Durable Polymer New-Generation Drug-Eluting Stent in Patients With Coronary Artery Disease With and Without Diabetes Mellitus

Tobias Lenz, Tobias Koch, Michael Joner, Erion Xhepa, Jens Wiebe, J J Coughlan, Alp Aytekin, Tareq Ibrahim, Massimiliano Fusaro, Salvatore Cassese, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati, Sebastian Kufner, ISAR‐TEST 4 (Intracoronary Stenting, Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents) Investigators †, Robert A Byrne, Steffen Massberg, K Anette Birkmeier, Stefanie Schulz, Jürgen Pache, Melchior Seyfarth, Julinda Mehilli, Albert Schömig, Petra Hoppmann, Tobias Lenz, Tobias Koch, Michael Joner, Erion Xhepa, Jens Wiebe, J J Coughlan, Alp Aytekin, Tareq Ibrahim, Massimiliano Fusaro, Salvatore Cassese, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati, Sebastian Kufner, ISAR‐TEST 4 (Intracoronary Stenting, Angiographic Results: Test Efficacy of 3 Limus‐Eluting Stents) Investigators †, Robert A Byrne, Steffen Massberg, K Anette Birkmeier, Stefanie Schulz, Jürgen Pache, Melchior Seyfarth, Julinda Mehilli, Albert Schömig, Petra Hoppmann

Abstract

Background Extended long-term follow-up data of new-generation drug-eluting stents in patients with diabetes mellitus is scant. The aim of this study is to assess the 10-year clinical outcome of new-generation biodegradable polymer-based sirolimus-eluting stents (Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (XIENCE) in patients with and without diabetes mellitus. Methods and Results In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with drug-eluting stents were compared. The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The analysis includes a total of 1951 patients (560 patients with and 1391 patients without diabetes mellitus) randomized to treatment with Yukon Choice PC (n=1299) or Xience (n=652). Regarding the primary end point, at 10 years patients with diabetes mellitus showed significantly higher major adverse cardiac event rates than patients without diabetes mellitus (P<0.001; hazard ratio [HR], 1.41; 95% CI, 1.22-1.63). There was no significant difference between patients treated with Yukon Choice PC versus Xience, neither in the subgroup of patients with (P=0.91; HR, 1.01; 95% CI, 0.79-1.30) nor without diabetes mellitus (P=0.50; HR, 0.94; 95% CI, 0.79-1.21). Rates of definite/probable stent thrombosis were 2.3% in patients with and 1.9% in patients without diabetes mellitus (HR, 1.27; 95% CI, 0.34-2.60; P=0.52), without significant differences between study devices. Conclusions The clinical outcome of patients with diabetes after percutaneous coronary intervention with different new-generation drug-eluting stents is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years. Registration URL: https://ichgcp.net/clinical-trials-registry/NCT00598676" title="See in ClinicalTrials.gov">NCT00598676.

Keywords: biodegradable polymer; diabetes mellitus; new‐generation drug‐eluting stent; permanent polymer.

Conflict of interest statement

MJ reports speaker fees from Biotronik, Boston Scientific, AstraZeneca, Coramaze, and OrbusNeich, as well as research grants from Biotronik and the European Society of Cardiology; HS reports honoraria fees from AstraZeneca, Bayer Vital, MSD SHARP&DOHME, Novartis, Servier, Sanofi‐Aventis, Boehringer Ingelheim, Daiichi Sankyo, Amgen, Pfizer, and consulting fees from AstraZeneca, Amgen, MSD SHARP&DOHME; SK reports speaker fees from Astra Zeneca and Bristol Myers Squibb. The remaining authors have no disclosures to report.

Figures

Figure 1. Comparison of cumulative incidence of…
Figure 1. Comparison of cumulative incidence of major adverse cardiac events in patients with vs without diabetes mellitus.
DM indicates diabetes mellitus; HR, hazard ratio; and MACE, major adverse cardiac events.
Figure 2. Comparison of all‐cause mortality in…
Figure 2. Comparison of all‐cause mortality in patients with vs without diabetes mellitus.
DM indicates diabetes mellitus; and HR, hazard ratio.
Figure 3. Comparison of cumulative incidence of…
Figure 3. Comparison of cumulative incidence of myocardial infarction in patients with vs without diabetes mellitus.
DM indicates diabetes mellitus; HR, hazard ratio; and MI, myocardial infarction.
Figure 4
Figure 4
Comparison of cumulative incidence of target lesion revascularization in patients with vs without diabetes mellitus. DM indicates diabetes mellitus; HR, hazard ratio; and TLR, target lesion revascularization.

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Source: PubMed

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