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Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents :...
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Titel: |
Clinical Outcomes According to Diabetic Status in Patients Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents : Prespecified Subgroup Analysis of the BIOSCIENCE Trial Prespecified Subgroup Analysis of the BIOSCIENCE Trial |
In: | Circulation: Cardiovascular Interventions, 8, 2015, 6 |
veröffentlicht: |
Ovid Technologies (Wolters Kluwer Health)
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ISSN: |
1941-7640 1941-7632 |
DOI: | 10.1161/circinterventions.114.002319 |
Zusammenfassung: | <jats:sec> <jats:title>Background—</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p> 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; <jats:italic>P</jats:italic> =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; <jats:italic>P</jats:italic> =0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58–1.33; <jats:italic>P</jats:italic> =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; <jats:italic>P</jats:italic> =0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39–1.25; <jats:italic>P</jats:italic> =0.23, in nondiabetics). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT01443104. </jats:p> </jats:sec> |
Format: | E-Article |
Quelle: | Ovid Technologies (Wolters Kluwer Health) (CrossRef) |
Sprache: | Englisch |