Treatment of coronary de novo lesions by a sirolimus- or paclitaxel-coated balloon

Ahmad, Wan Azman Wan and Nuruddin, Amin Ariff and Kader, Muhamad Ali S. K. Abdul and Ong, Tiong Kiam and Liew, Houng Bang and Ali, Rosli Mohd and Mahmood Zuhdi, Ahmad Syadi and Ismail, Muhammad Dzafir and Yusof, Ahmad K. M. and Schwenke, Carsten and Kutschera, Maren and Scheller, Bruno (2022) Treatment of coronary de novo lesions by a sirolimus- or paclitaxel-coated balloon. Jacc-Cardiovascular Interventions, 15 (7). pp. 770-779. ISSN 1936-8798, DOI

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OBJECTIVES The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). BACKGROUND There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents. METHODS Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4 mu g/mm(2)) with a PCB (SeQuent Please, B. Braun Melsungen; 3 mu g/mm(2)). The primary endpoint was angiographic late lumen loss (LLL) at 6 months. Secondary endpoints included major adverse cardiovascular events and individual clinical endpoints such as cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. RESULTS Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment LLL was 0.01 +/- 0.33 mm in the PCB group versus 0.10 +/- 0.32 mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95% CI: -0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P = 0.019). Major adverse cardiovascular events up to 12 months also did not differ between the groups. CONCLUSIONS This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia SCBDNMAL]; NCT04017364) (C) 2022 by the American College of Cardiology Foundation.

Item Type: Article
Funders: None
Uncontrolled Keywords: Coronary de novo lesions; Paclitaxel coated balloon; Sirolimus-coated balloon
Subjects: Q Science > Q Science (General)
R Medicine > R Medicine (General)
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 20 Oct 2023 02:14
Last Modified: 20 Oct 2023 02:26

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