MedStar Authors catalog › Details for: Efficacy and Safety of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin, Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization of Patients With Diabetes Mellitus.
Efficacy and Safety of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin, Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization of Patients With Diabetes Mellitus.
Citation: ; American Journal of Cardiology. 124(7):1020-1026, 2019 10 01..Journal: The American journal of cardiology.Published: ; 2019; ISSN: 0002-9149.Full author list: Kandzari D; Kolm P; Koolen JJ; Lipinski MJ; Saito S; Shlofmitz E; Torguson R; Waksman R; Windecker S.UI/PMID: 31353004.Subject(s): *Absorbable Implants | Treatment Outcome | *Sirolimus/ad [Administration & Dosage] | Polymers | Percutaneous Coronary Intervention/is [Instrumentation] | Middle Aged | Male | Immunosuppressive Agents/ad [Administration & Dosage] | Humans | Female | *Everolimus/ad [Administration & Dosage] | Equipment Design | *Drug-Eluting Stents | Diabetes Complications/th [Therapy] | *Diabetes Complications/co [Complications] | *Coronary Artery Disease/th [Therapy] | Coronary Artery Disease/co [Complications] | AgedInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.amjcard.2019.06.021 (Click here)Abbreviated citation: ; Am J Cardiol. 124(7):1020-1026, 2019 10 01.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006.Abstract: Patients with diabetes mellitus are prone to increased adverse outcomes after percutaneous coronary intervention, even with contemporary drug-eluting stents. Randomized controlled trials have demonstrated comparable clinical outcomes between an ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES) and a thin-strut durable-polymer everolimus-eluting stent (DP-EES) that has specific labeling for patients with diabetes. We aimed to evaluate the safety and efficacy of the BP-SES in patients with diabetes mellitus. To determine the performance of the BP-SES in diabetic patients, patient-level data from the BIOFLOW II, IV, and V randomized controlled trials were pooled. The primary end point was target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, and definite or probable stent thrombosis, at 1 year. Among 1,553 BP-SES and 791 DP-EES patients, 757 diabetic patients were identified. Of the diabetic patients included in this analysis (494 BP-SES vs 263 DP-EES), the proportion of insulin- and noninsulin-treated patients was similar between groups. The 1-year TLF rate in the diabetic population was 6.3% in the BP-SES group and 8.7% in the DP-EES group (hazard ratio 0.82, 95% confidence interval 0.047 to 1.43, p=0.493). There were no significant differences, based on stent type or diabetes treatment regimen, in TLF hazards. In a patient-level pooled analysis of the diabetic population from randomized trials, 1-year clinical safety and efficacy outcomes were similar in patients treated with ultrathin BP-SES and thin-strut DP-EES. Copyright (c) 2019. Published by Elsevier Inc.