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Randomized Controlled Trial
. 2022 Feb;99(2):366-372.
doi: 10.1002/ccd.29685. Epub 2021 Apr 3.

Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy

Nicole D van Hemert  1 , Rik Rozemeijer  1 , Michiel Voskuil  1 , Mèra Stein  2 , Peter Frambach  3 , Saskia Z Rittersma  1 , Adriaan O Kraaijeveld  1 , Geert E H Leenders  1 , Pim van der Harst  1 , Pierfrancesco Agostoni  4 , Pieter R Stella  1 ; ReCre8 Study Investigators
Affiliations
Randomized Controlled Trial

Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy

Nicole D van Hemert et al. Catheter Cardiovasc Interv. 2022 Feb.

Abstract

Objectives: The purpose of this analysis was to compare target-lesion failure (TLF) of a permanent polymer zotarolimus-eluting stent (PP-ZES) versus a polymer-free amphilimus-eluting stent (PF-AES) in diabetics.

Background: The improvement of outcomes with new-generation drug-eluting stent as seen in the general population is less pronounced among diabetics. The PF-AES introduces an elution-technology with potential enhanced performance in diabetics.

Methods: In this subanalysis of the ReCre8 trial, patients were randomized to either a PP-ZES or PF-AES after stratification for diabetes and troponin status. The primary device-oriented endpoint was TLF, a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization.

Results: In the ReCre8 trial, 304 (20%) patients were diabetic and 96 (6%) had insulin-dependent diabetes mellitus. There was no statistically significant difference between the two study arms regarding the primary endpoint (PP-ZES 7.2% vs. PF-AES 4.0%; p = .21), although the composite of net adverse clinical events was higher in the PP-ZES arm (15.7 vs. 8.0%; p = .035). Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32). Regarding insulin-treated diabetics, TLF was higher in the PP-ZES arm (14.9 vs. 2.1%; p = .022).

Conclusions: Diabetics could potentially benefit from a dedicated stent, releasing sirolimus with a lipophilic carrier (amphilimus-formulation). Future trials should confirm the potential benefit of a PF-AES in this population.

Keywords: diabetes mellitus; drug-eluting stents; percutaneous coronary intervention.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Kaplan–Meier time‐to‐event estimates for TLF compared using log‐rank test. (a) TLF for PP‐ZES and PF‐AES in diabetic patients. (b) TLF for PP‐ZES and PF‐AES in insulin‐dependent diabetic patients. TLF was defined as a composite of cardiac death, target‐vessel myocardial infarction and target‐lesion revascularization. PF‐AES, polymer‐free amphilimus‐eluting stents; PP‐ZES, permanent polymer zotarolimus‐eluting stents; TLF, target‐lesion failure [Color figure can be viewed at wileyonlinelibrary.com]
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