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J Am Heart Assoc. 2019 Nov 19;8(22):e013607. doi: 10.1161/JAHA.119.013607. Epub 2019 Nov 7.

Five-Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents.

Author information

1
Division of Cardiology Geneva University Hospitals Geneva Switzerland.
2
Institute of Social and Preventive Medicine and Clinical Trials Unit Bern University Hospital Bern Switzerland.
3
Department of Cardiology Triemlispital Zurich Switzerland.
4
Department of Cardiology Bern University Hospital Bern Switzerland.
5
Department of Cardiology Lausanne University Hospital Lausanne Switzerland.
6
Department of Cardiology Kantonsspital Aarau Switzerland.
7
Department of Cardiology University and Hospital Fribourg Switzerland.
8
Department of Cardiology Kantonsspital St Gallen Switzerland.
9
Department of Cardiology Basel University Hospital Basel Switzerland.
10
Department of Cardiology Kantonsspital Luzern Switzerland.
11
Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research Centre Li Ka Shing Knowledge Institute of St Michael's Hospital University of Toronto Canada.

Abstract

Background The choice of optimal drug-eluting stent therapy for patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long-term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus-eluting stents (BP-SES) versus durable polymer everolimus-eluting stents (DP-EES) in patients with DM. Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization) trial (NCT01443104), patients randomly assigned to ultrathin-strut BP-SES or thin-strut DP-EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM. Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP-SES and 57 patients (25.8%) treated with DP-EES (risk ratio, 1.23; 95% CI, 0.87-1.73 [P=0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP-SES and 132 patients (16.8%) treated with DP-EES (risk ratio, 0.98; 95% CI, 0.77-1.26 [P=0.90; P for interaction=0.31]). Cumulative 5-year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP-SES or DP-EES. There was no interaction between diabetic status and treatment effect of BP-SES versus DP-EES. Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin-strut BP-SES or thin-strut DP-EES. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01443104.

KEYWORDS:

biodegradable polymer; diabetes mellitus; drug‐eluting stent; long‐term outcomes; ultrathin stent strut

PMID:
31696762
DOI:
10.1161/JAHA.119.013607
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