Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial.

MedStar author(s):
Citation: Circulation: Cardiovascular Interventions. 8(2):e001441, 2015 Feb.PMID: 25634905Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleSubject headings: *Angioplasty, Balloon, Coronary/is [Instrumentation] | *Cardiovascular Agents/ad [Administration & Dosage] | *Coronary Artery Disease/th [Therapy] | *Coronary Restenosis/pc [Prevention & Control] | *Coronary Vessels/de [Drug Effects] | *Drug-Eluting Stents | *Polymers | *Sirolimus/aa [Analogs & Derivatives] | Aged | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | Coronary Artery Disease/di [Diagnosis] | Coronary Restenosis/di [Diagnosis] | Coronary Restenosis/et [Etiology] | Coronary Vessels/pa [Pathology] | Coronary Vessels/us [Ultrasonography] | Europe | Female | Humans | Kaplan-Meier Estimate | Male | Middle Aged | Neointima | Predictive Value of Tests | Prosthesis Design | Risk Factors | Sirolimus/ad [Administration & Dosage] | Time Factors | Tomography, Optical Coherence | Treatment Outcome | Ultrasonography, InterventionalYear: 2015Local holdings: Available online from MWHC library: 2008 - presentISSN:
  • 1941-7640
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.CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.Copyright � 2013 American Heart Association, Inc.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.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).All authors: Barragan P, Bilger J, Cook S, Erne P, Goicolea J, Haude M, Juni P, Lefevre T, Merkely B, Neumann FJ, Piot C, Richardt G, Sabate M, Schneider H, Slagboom T, Stangl K, Waksman R, Windecker S, Witzenbichler B, Zaugg SFiscal year: FY2015Digital Object Identifier: Date added to catalog: 2016-01-13
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 25634905 Available 25634905

Available online from MWHC library: 2008 - present

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.

CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.Copyright � 2013 American Heart Association, Inc.

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.

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).

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