Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: Results of the Randomized BIOFLOW-II Trial.

Windecker, Stephan; Haude, Michael; Neumann, Franz-Josef; Stangl, Karl; Witzenbichler, Bernhard; Slagboom, Ton; Sabaté, Manel; Goicolea, Javier; Barragan, Paul; Cook, Stéphane; Piot, Christophe; Richardt, Gert; Merkely, Béla; Schneider, Henrik; Bilger, Johannes; Erne, Paul; Waksman, Ron; Zaugg, Serge; Jüni, Peter and Lefèvre, Thierry (2015). Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent: Results of the Randomized BIOFLOW-II Trial. Circulation: Cardiovascular interventions, 8(2), e001441. Lippincott Williams & Wilkins 10.1161/CIRCINTERVENTIONS.114.001441

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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. 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). 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. CLINICAL TRIAL REGISTRATION URL http://www.clinicaltrials.gov. Unique identifier: NCT01356888.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan; Zaugg, Serge and Jüni, Peter

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1941-7632

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

10 Feb 2015 09:30

Last Modified:

16 Jun 2016 10:06

Publisher DOI:

10.1161/CIRCINTERVENTIONS.114.001441

PubMed ID:

25634905

BORIS DOI:

10.7892/boris.62777

URI:

https://boris.unibe.ch/id/eprint/62777

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