Safety and efficacy of everolimus-eluting bioabsorbable polymer-coated stent in patients with long coronary lesions: the EVOLVE 48 study

Karmpaliotis, D. et al. (2022) Safety and efficacy of everolimus-eluting bioabsorbable polymer-coated stent in patients with long coronary lesions: the EVOLVE 48 study. Catheterization and Cardiovascular Interventions, 99(2), pp. 373-380. (doi: 10.1002/ccd.29798) (PMID:34051049)

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Abstract

Objectives: The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. Background: Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long-term data in a broad population of patients undergoing PCI. Methods: Patients with lesion length >34- ≤44 mm and reference vessel diameter (RVD) ≥2.5- ≤ 4.0 mm were enrolled in this prospective, multicenter, single-arm study. The primary endpoint was 12-month target lesion failure (TLF; composite of target lesion revascularization [TLR], target-vessel myocardial infarction [TV-MI], or cardiac death) compared to a prespecified performance goal (PG). Results: A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre-TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One-year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV-MI in two patients treated with SYNERGY 48 mm stent. Between the 1-2-year timeframe, TV-MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. Conclusions: PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.

Item Type:Articles
Keywords:Coronary artery disease, drug eluting stent, long lesions, percutaneous coronary intervention-complex PCI.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Oldroyd, Dr Keith
Authors: Karmpaliotis, D., Stoler, R., Walsh, S., El-Jack, S., Potluri, S., Moses, J., Oldroyd, K., Banning, A., Webster, M., Zaman, A., Wu, W., Ahmed, M., Underwood, P., and Allocco, D.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Catheterization and Cardiovascular Interventions
Publisher:Wiley
ISSN:1522-1946
ISSN (Online):1522-726X
Published Online:29 May 2021
Copyright Holders:Copyright © 2021 The Authors
First Published:First published in Catheterization and Cardiovascular Interventions 99(2): 373-380
Publisher Policy:Reproduced under a Creative Commons License

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