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

• Published in: The American heart journal Vol. 162; no. 5; pp. 922 - 931
• Main Authors: Gutiérrez-Chico, Juan Luis, MD, PhD, FESC, FACC, Jüni, Peter, MD, FESC, García-García, Héctor M., MD, PhD, Regar, Evelyn, MD, PhD, FESC, Nüesch, Eveline, PhD, Borgia, Francesco, MD, van der Giessen, Willem J., MD, PhD, FESC, Davies, Simon, MD, van Geuns, Robert Jan, MD, PhD, FESC, Secco, Gioel Gabrio, MD, Meis, Susanne, MD, Windecker, Stephan, MD, FESC, Serruys, Patrick W., MD, PhD, FESC, FACC, di Mario, Carlo, MD, PhD, FESC, FACC
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.11.2011; Mosby; Elsevier Limited
• Subjects: Adult; Angioplasty, Balloon, Coronary; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular; Cardiovascular disease; Case-Control Studies; Coronary Stenosis - pathology; Coronary Stenosis - therapy; Drug-Eluting Stents; Female; Heart attacks; Humans; Immunosuppressive Agents - administration & dosage; Male; Medical sciences; Polymers - administration & dosage; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Randomized Controlled Trials as Topic; Serum Albumin - administration & dosage; Serum Albumin, Human; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Stents; Tomography, Optical Coherence; Treatment Outcome; Volumetric analysis; Switzerland; SES; OCT; intravascular ultrasound; drug-eluting stent; MLA; sirolimus-eluting stent; PLA; optical coherence tomography; IVUS; NIH; neointimal hyperplasia; QCA; minimal lumen area; BES; polylactic acid; quantitative coronary angiography; DES; ISA; biolimus-eluting stent; incomplete stent apposition; Optical coherence tomography; Biodegradability; Control release polymer; Complete; Resorption; Instrumentation therapy; Cardiovascular disease; Absorbable; Coverage; Long term; Tissue; Sequential; Circulatory system; Cardiology; Drug eluting stent; Comparative study
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2011.09.005

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.