Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus - Eluting

Abstract

Diabetic patients are at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with patients without diabetes mellitus. New-generation drugeluting stents (DES) are recommended for treatment of patients with diabetes mellitus undergoing PCI because of a lower risk of repeat revascularization compared with bare-metal stents and early generation DES. Among available DES, the thin strut durable polymer everolimus-eluting stent (DP-EES) has been shown to provide the best safety and efficacy profile in this high-risk group. However, diabetes mellitus attenuates the antirestenotic effects of DES and the risk of adverse events after PCI is higher for diabetic patients compared with patients Background—Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. Methods and Results—BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27–2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67–2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58–1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49–3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39–1.25; P=0.23, in nondiabetics). Conclusions—In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated with BP-SES or DP-EES were comparable at 1 year. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01443104. (Circ Cardiovasc Interv. 2015;8:e002319. DOI: 10.1161/CIRCINTERVENTIONS.114.002319.)

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@inproceedings{Franzone2015ClinicalOA, title={Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus - Eluting}, author={Anna Franzone and Thomas Pilgrim and Dik Heg and Marco Roffi and David Tueller and Andr{\'e} Vuilliomenet and Olivier Muller and St{\'e}phane Cook and Daniel Weilenmann and Christoph A. Kaiser and Peiman Jamshidi and Lorenz Raeber and Stefan Stortecky and Peter M . Wenaweser and Peter J{\"{u}ni and Stephan Windecker}, year={2015} }