Treatment of Coronary De Novo Lesions by a Sirolimus- or Paclitaxel-Coated Balloon.

Autor:	Ahmad WAW; Department of Medicine, University Malaya Medical Center, Kuala Lumpur, Malaysia., Nuruddin AA; Cardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia., Abdul Kader MASK; Cardiology Department, Hospital Pulau Pinang, George Town, Malaysia., Ong TK; Cardiology Department, Sarawak Heart Centre, Kota Samarahan, Malaysia., Liew HB; Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia., Ali RM; Cardiac Vascular Sentral Kuala Lumpur, Kuala Lumpur, Malaysia., Mahmood Zuhdi AS; Department of Medicine, University Malaya Medical Center, Kuala Lumpur, Malaysia., Ismail MD; Department of Medicine, University Malaya Medical Center, Kuala Lumpur, Malaysia., Yusof AKM; Cardiology Department, National Heart Institute Malaysia, Kuala Lumpur, Malaysia., Schwenke C; SCO: SSiS, Berlin, Germany., Kutschera M; Experimental Radiology, Charité Universitätsmedizin, Berlin, Germany., Scheller B; Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany. Electronic address: bruno.scheller@uks.eu.
Jazyk:	angličtina
Zdroj:	JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2022 Apr 11; Vol. 15 (7), pp. 770-779. Date of Electronic Publication: 2022 Mar 16.
DOI:	10.1016/j.jcin.2022.01.012
Abstrakt:	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 μg/mm 2 ) with a PCB (SeQuent Please, B. Braun Melsungen; 3 μg/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). Competing Interests: Funding Support and Author Disclosures Dr Scheller is a shareholder in InnoRa. Dr Schwenke is consultant to InnoRa on a honorary basis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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