| Autor: |
Wan Azman Wan, Ahmad, Amin Ariff, Nuruddin, Muhamad Ali S K, Abdul Kader, Tiong Kiam, Ong, Houng Bang, Liew, Rosli Mohd, Ali, Ahmad Syadi, Mahmood Zuhdi, Muhammad Dzafir, Ismail, Ahmad K M, Yusof, Carsten, Schwenke, Maren, Kutschera, Bruno, Scheller |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
JACC: Cardiovascular Interventions. 15:770-779 |
| ISSN: |
1936-8798 |
| DOI: |
10.1016/j.jcin.2022.01.012 |
| Popis: |
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).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.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 μg/mmQuantitative 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.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). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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