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

Juan F Iglesias, Dik Heg, Marco Roffi, David Tüller, Jonas Lanz, Fabio Rigamonti, Olivier Muller, Igal Moarof, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Florim Cuculi, Marco Valgimigli, Peter Jüni, Stephan Windecker, Thomas Pilgrim, Juan F Iglesias, Dik Heg, Marco Roffi, David Tüller, Jonas Lanz, Fabio Rigamonti, Olivier Muller, Igal Moarof, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Florim Cuculi, Marco Valgimigli, Peter Jüni, Stephan Windecker, Thomas Pilgrim

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.

Figures

Figure 1
Figure 1
Patient flow according to CONSORT statement. BMS indicates bare‐metal stents; BP‐SES, biodegradable polymer sirolimus‐eluting stents; CABG, coronary artery bypass grafting; DP‐EES, durable polymer everolimus‐eluting stents; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Time to event curves for the composite end point target lesion failure and individual components of the primary end point up to 5 years in patients with diabetes mellitus (DM) vs patients without DM. A, Target lesion failure; B, cardiac death; C, target vessel (TV) myocardial infarction; D, clinically driven target lesion revascularization (TLR). Blue lines indicate biodegradable polymer sirolimus‐eluting stent, patients with DM subgroup (BP‐SES, DM); red lines indicate durable polymer everolimus‐eluting stent, patients with DM subgroup (DP‐EES, DM); grey lines indicate biodegradable polymer sirolimus‐eluting stent, patients without DM subgroup (BP‐SES, Non); and orange lines indicate durable polymer everolimus‐eluting stent, patients without DM subgroup (DP‐EES, Non). RR indicates rate ratio.

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