Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer
Juan Luis Gutiérrez-Chico, Peter Jüni, Héctor M García-García, Evelyn Regar, Eveline Nüesch, Francesco Borgia, Willem J van der Giessen, Simon Davies, Robert Jan van Geuns, Gioel Gabrio Secco, Susanne Meis, Stephan Windecker, Patrick W Serruys, Carlo di Mario, Juan Luis Gutiérrez-Chico, Peter Jüni, Héctor M García-García, Evelyn Regar, Eveline Nüesch, Francesco Borgia, Willem J van der Giessen, Simon Davies, Robert Jan van Geuns, Gioel Gabrio Secco, Susanne Meis, Stephan Windecker, Patrick W Serruys, Carlo di Mario
Abstract
Background: Biolimus-eluting stents (BESs) with a biodegradable polymer in abluminal coating achieve more complete coverage at 9 months compared with sirolimus-eluting stents (SESs) with a durable polymer, as assessed by optical coherence tomography (OCT). Whether this advantage persists or augments after complete resorption of the polymer (>12 months) is unknown.
Methods: The LEADERS trial compared the performance of BES with that of SES. Patients were randomly allocated to a sequential angiographic follow-up, including OCT in selected sites, at 9 and 24 months. Struts coverage was compared using Bayesian hierarchical models as the primary outcome for the OCT substudy.
Results: Fifty-six patients (26 BES, 30 SES) were enrolled in the OCT substudy. Twenty-one patients (10 BES, 11 SES) agreed to perform a second OCT follow-up at 24 months. Eleven lesions and 12 stents were analyzed sequentially in the BES group (2,455 struts at 9 months, 2,131 struts at 24 months) and 11 lesions and 18 stents in the SES group (3,421 struts at 9 months, 4,170 struts at 24 months). The previously reported advantage of BES over SES in terms of better strut coverage at 9 months was followed by improvement in coverage of the SES, resulting in identical coverage in both BES and SES at 24 months: 1.5% versus 1.8% uncovered struts, difference -0.2%, 95% credibility interval, -3.2% to 2.6%, P = .84.
Conclusions: More complete strut coverage of BES as compared with SES at 9 months was followed by improvement of coverage in SES between 9 and 24 months and a similar long-term coverage in both stent types at 24 months.
Trial registration: ClinicalTrials.gov NCT00389220.
Copyright © 2011 Mosby, Inc. All rights reserved.
Source: PubMed