TY  - BOOK
AU  - Kolm, Paul
AU  - Lipinski, Michael J
AU  - Shlofmitz, Evan
AU  - Torguson, Rebecca
AU  - Waksman, Ron
TI  - 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
SN  - 0002-9149
PY  - 2019///
KW  - *Absorbable Implants
KW  - *Coronary Artery Disease/th [Therapy]
KW  - *Diabetes Complications/co [Complications]
KW  - *Drug-Eluting Stents
KW  - *Everolimus/ad [Administration & Dosage]
KW  - *Sirolimus/ad [Administration & Dosage]
KW  - Aged
KW  - Coronary Artery Disease/co [Complications]
KW  - Diabetes Complications/th [Therapy]
KW  - Equipment Design
KW  - Female
KW  - Humans
KW  - Immunosuppressive Agents/ad [Administration & Dosage]
KW  - Male
KW  - Middle Aged
KW  - Percutaneous Coronary Intervention/is [Instrumentation]
KW  - Polymers
KW  - Treatment Outcome
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
N2  - 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
UR  - https://dx.doi.org/10.1016/j.amjcard.2019.06.021
ER  -