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.

Détails

ID Serval
serval:BIB_2912BA5F5A0C
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
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.
Périodique
Circulation. Cardiovascular Interventions
Auteur(s)
Franzone A., Pilgrim T., Heg D., Roffi M., Tüller D., Vuilliomenet A., Muller O., Cook S., Weilenmann D., Kaiser C., Jamshidi P., Räber L., Stortecky S., Wenaweser P., Jüni P., Windecker S.
ISSN
1941-7632 (Electronic)
ISSN-L
1941-7640
Statut éditorial
Publié
Date de publication
2015
Peer-reviewed
Oui
Volume
8
Numéro
6
Pages
e002319
Langue
anglais
Résumé
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.
Mots-clé
Absorbable Implants, Aged, Antibiotics, Antineoplastic/administration & dosage, Coronary Angiography, Diabetic Angiopathies/therapy, Drug-Eluting Stents/statistics & numerical data, Everolimus/administration & dosage, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention/instrumentation, Polymers, Sirolimus/administration & dosage, Treatment Outcome
Pubmed
Web of science
Open Access
Oui
Création de la notice
17/03/2016 20:01
Dernière modification de la notice
20/08/2019 14:08
Données d'usage