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Lookup NU author(s): Professor Azfar Zaman
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.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.
Author(s): 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, Allocco D
Publication type: Article
Publication status: Published
Journal: Catheterization and Cardiovascular Interventions
Year: 2022
Volume: 99
Issue: 2
Pages: 373-380
Print publication date: 27/02/2022
Online publication date: 29/05/2021
Acceptance date: 09/05/2021
Date deposited: 17/06/2021
ISSN (print): 1522-1946
ISSN (electronic): 1522-726X
Publisher: John Wiley and Sons Inc
URL: https://doi.org/10.1002/ccd.29798
DOI: 10.1002/ccd.29798
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