Three‐year follow up of biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials
- 15 January 2020
- journal article
- research article
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 95 (S1), 565-571
- https://doi.org/10.1002/ccd.28713
Abstract
Objectives To analyze the 3‐year outcomes of the biodegradable polymer cobalt‐chromium sirolimus‐eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS. Background Though approved by CFDA, the long‐term safety and efficacy of EXCROSSAL is still unknown. Methods CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single‐arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3‐year follow‐up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3‐year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV‐MI), and clinically indicated target lesion revascularization (CI‐TLR). The patient‐oriented composite endpoint (PoCE) (all‐cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed. Results A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3‐year follow‐up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi‐lesion PCI, and multi‐vessel disease. Conclusions The 3‐year follow‐up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug‐eluting stent.Keywords
Funding Information
- Natural Science Foundation of Liaoning Province (20180550677)
This publication has 26 references indexed in Scilit:
- First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: Clinical, Angiographic, and OCT outcomes of CREDIT-1Catheterization and Cardiovascular Interventions, 2015
- Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting StentsCirculation, 2015
- Three-Year Results Comparing Platinum-Chromium PROMUS Element and Cobalt-Chromium XIENCE V Everolimus-Eluting Stents in De Novo Coronary Artery Narrowing (from the PLATINUM Trial)The American Journal of Cardiology, 2014
- Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trialThe Lancet, 2013
- Head-to-Head Comparison of the Neointimal Response Between Metallic and Bioresorbable Everolimus-Eluting Scaffolds Using Optical Coherence TomographyJACC: Cardiovascular Interventions, 2011
- Sustained clinical safety and efficacy of a biodegradable‐polymer coated sirolimus‐eluting stent in “real‐world” practice: Three‐year outcomes of the CREATE (multi‐center registry of EXCEL biodegradable polymer drug eluting stents) studyCatheterization and Cardiovascular Interventions, 2011
- Clinical End Points in Coronary Stent TrialsCirculation, 2007
- Stent Thrombosis in Randomized Clinical Trials of Drug-Eluting StentsThe New England Journal of Medicine, 2007
- Analysis of 14 Trials Comparing Sirolimus-Eluting Stents with Bare-Metal StentsThe New England Journal of Medicine, 2007
- Pathology of Drug-Eluting Stents in Humans: Delayed Healing and Late Thrombotic RiskJournal of the American College of Cardiology, 2006