Long‐term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer‐coated sirolimus‐eluting stents
- 24 July 2008
- journal article
- research article
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 72 (2), 177-183
- https://doi.org/10.1002/ccd.21600
Abstract
Background: The residual drug carriers on drug-eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus-eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). Objective: To evaluate the long-term efficacy and safety of EXCEL stent on treating CHD patients. Methods: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single-center registry. Antiplatelet protocol was 6-month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in-segment and in-stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. Results: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target-lesion revascularizations due to in-stent restenosis (ISR). All patients received follow-up up to 24 ± 0.4 months and no cardiac death, MI, and in-stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in-stent lesion restenosis, 5.4% (6/112) in-segment lesion restenosis, 0.12 ± 0.34 mm in-stent late lumen loss, and 0.08 ± 0.35 mm in-segment late lumen loss. Conclusions: In this single-center experience with complex patients and lesions, the EXCELTM stent implantation with 6-month dual antiplatelet treatment proved to markedly reduce the incidence of 24-month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials.Keywords
This publication has 25 references indexed in Scilit:
- Prevention of Premature Discontinuation of Dual Antiplatelet Therapy in Patients With Coronary Artery StentsCirculation, 2007
- TCT Daily: ESTROFA: Late Thrombosis Not Increased in DES Patients: Spanish Registry of Drug‐Eluting Stents Shows STEMI, LAD Artery Lesions, Significant Risk FactorsJournal of Interventional Cardiology, 2007
- Effectiveness and safety of the sirolimus‐eluting stents coated with bioabsorbable polymer coating in human coronary arteriesCatheterization and Cardiovascular Interventions, 2006
- Polymers, Drug Release, and Drug‐Eluting StentsJournal of Interventional Cardiology, 2006
- Very late thrombosis after drug‐eluting stentsCatheterization and Cardiovascular Interventions, 2006
- Drug-Eluting Stents in the Treatment of Intermediate Lesions: Pooled Analysis From Four Randomized TrialsJournal of the American College of Cardiology, 2006
- Late Incomplete Stent Apposition After Sirolimus-Eluting Stent Implantation: A Serial Intravascular Ultrasound AnalysisJournal of the American College of Cardiology, 2005
- Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting StentCirculation, 2004
- Long-Term Follow-Up of Incomplete Stent Apposition in Patients Who Received Sirolimus-Eluting Stent for De Novo Coronary Lesions: An Intravascular Ultrasound AnalysisCirculation, 2003
- Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary ArteryNew England Journal of Medicine, 2003