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

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.

One-year outcomes of polymer-free amphilimus-eluting stents versus durable polymer zotarolimus-eluting stents in patients with diabetes mellitus: a meta-analysis

“…Finally, only 4 studies [ 13 – 16 ] were selected for this analysis. The flow diagram for the study selection has been represented by Fig.…”

“…It should be noted that our current study only involved participants with DM in contrast to the other study which included participants from the general population with coronary artery disease. A substudy of the ReCre8 trial consisting only of patients with DM showed composite of net adverse clinical events to be significantly higher with durable polymer ZES, and TLF was also higher with ZES among patients with insulin-treated DM [ 13 ].…”

Long‐term follow‐up of contemporary drug‐eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial

“…Event rates among diabetic patients in this trial were higher compared to event rates in the ReCre8 trial, however rates are comparable when taking the ~4% of TLF in both stent arms in the first days into account. Interestingly, no significant difference in TLF between the stent arms was found among IDDM patients, a subgroup that showed a pronounced benefit of PF‐AES implantation after 1 year in the ReCre8 trial 4 …”

“…Interestingly, no significant difference in TLF between the stent arms was found among IDDM patients, a subgroup that showed a pronounced benefit of PF-AES implantation after 1 year in the ReCre8 trial. 4 A prospective trial including patients undergoing PCI with implantation of second-generation DES 11 reported comparable event rates for TLF-components among their diabetic population. Cardiac death occurred in 5% after 3 years (ReCre8 5.0%) and target-lesion revascularization in 5.5% (ReCre8 5.6%).…”

“…In the diabetic cohort of the ReCre8 trial, evaluation of 1‐year clinical outcomes following implantation of a permanent polymer zotarolimus‐eluting stent (PP‐ZES) as compared to a polymer‐free amphilimus‐eluting stent (PF‐AES) has been previously performed 4 . Our hypothesis‐generating results demonstrated a higher risk of net adverse clinical events (NACE) in diabetic patients, and a higher risk of both target‐lesion failure (TLF) and NACE in insulin‐dependent diabetics (IDDM) in the PP‐ZES arm, as compared to the PF‐AES arm.…”