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 - 16/11/11
, Peter Jüni, MD, FESC b, Héctor M. García-García, MD, PhD c, Evelyn Regar, MD, PhD, FESC a, Eveline Nüesch, PhD b, Francesco Borgia, MD d, Willem J. van der Giessen, MD, PhD, FESC a, Simon Davies, MD d, Robert Jan van Geuns, MD, PhD, FESC a, Gioel Gabrio Secco, MD d, Susanne Meis, MD e, Stephan Windecker, MD, FESC f, Patrick W. Serruys, MD, PhD, FESC, FACC a, Carlo di Mario, MD, PhD, FESC, FACC dRésumé |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations : BES, DES, ISA, IVUS, MLA, NIH, OCT, PLA, QCA, SES
Plan
| RCT reg #NCT00389220. |
Vol 162 - N° 5
P. 922-931 - novembre 2011 Retour au numéro
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