MedStar Authors catalog › Details for: Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.
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Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.

by Waksman, Ron.
Citation: Circulation: Cardiovascular Interventions. 8(2):e001441, 2015 Feb..ISSN: 1941-7640.Full author list: Windecker S; Haude M; Neumann FJ; Stangl K; Witzenbichler B; Slagboom T; Sabate M; Goicolea J; Barragan P; Cook S; Piot C; Richardt G; Merkely B; Schneider H; Bilger J; Erne P; Waksman R; Zaugg S; Juni P; Lefevre T.UI/PMID: 25634905.Subject(s): Aged | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | *Angioplasty, Balloon, Coronary/is [Instrumentation] | *Cardiovascular Agents/ad [Administration & Dosage] | Coronary Artery Disease/di [Diagnosis] | *Coronary Artery Disease/th [Therapy] | Coronary Restenosis/di [Diagnosis] | Coronary Restenosis/et [Etiology] | *Coronary Restenosis/pc [Prevention & Control] | *Coronary Vessels/de [Drug Effects] | Coronary Vessels/pa [Pathology] | Coronary Vessels/us [Ultrasonography] | *Drug-Eluting Stents | Europe | Female | Humans | Kaplan-Meier Estimate | Male | Middle Aged | Neointima | *Polymers | Predictive Value of Tests | Prosthesis Design | Risk Factors | Sirolimus/ad [Administration & Dosage] | *Sirolimus/aa [Analogs & Derivatives] | Time Factors | Tomography, Optical Coherence | Treatment Outcome | Ultrasonography, InterventionalInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Online resources: Click here to access online Digital Object Identifier: http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.001441 (Click here) Abbreviated citation: Circ., Cardiovasc. interv.. 8(2):e001441, 2015 Feb.Local Holdings: Available online from MWHC library: 2008 - present.Abstract: BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months.Abstract: METHODS AND RESULTS: A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10+/-0.32 versus 0.11+/-0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10+/-0.04 mm versus 0.11+/-0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16+/-0.33 mm(2) versus X-EES, 0.43+/-0.56 mm(2); P=0.04).Abstract: CONCLUSIONS: Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up.Abstract: CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.Copyright � 2013 American Heart Association, Inc.

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