Design and rationale of a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the Biolimus A9™ drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM)
- PMID: 37328392
- DOI: 10.1016/j.carrev.2023.06.004
Design and rationale of a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the Biolimus A9™ drug coated balloon for the treatment of in-stent restenosis: First-in-man trial (REFORM)
Abstract
Background: Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative to traditional paclitaxel- and sirolimus-coated devices. Hence, we sought to investigate the safety and efficacy of this novel DCB in the treatment of coronary ISR.
Methods and design: REFORM (NCT04079192) is a prospective, multicenter, single blind, randomized controlled trial comparing the BA9-DCB (Biosensors Europe SA, Morges, Switzerland) to the paclitaxel-coated SeQuent® Please DCB (Braun Melsungen AG, Germany) in the treatment of coronary ISR. A total of 201 patients with coronary artery disease and an indication for interventional treatment of ISR in a bare-metal stent (BMS) or drug-eluting stent (DES) have been randomized 2:1 to receive treatment with the BA9- or the paclitaxel-DCB comparator. Patients were enrolled across 24 investigational centers in Europe and Asia. The primary endpoint is percent diameter stenosis (%DS) of the target segment as assessed by quantitative coronary angiography (QCA) at 6 months. Key secondary endpoints are in-stent late lumen loss, binary restenosis, target lesion failure, target vessel failure, myocardial infarction and death at 6 months. Subjects will be followed for 24 months from enrolment.
Implications: The REFORM trial will seek to prove that the BA9-DCB is non-inferior to the standard paclitaxel-DCB comparator in the treatment of coronary ISR with respect to %DS at 6 months and has similar safety characteristics.
Keywords: Biolimus A9™; Drug coated balloon; In-stent restenosis; Percutaneous coronary intervention; Randomized clinical trial.
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of competing interest R.A.B. has not received personal payments from medical device or pharmaceutical companies and reports research grants to the institution of employment from Abbott Vascular, Biosensors, Biotronik and Boston Scientific. J.H. received grants from National Evidence-based Healthcare Collaborating Agency, Ministry of Health & Welfare, Republic of Korea, Abbott Vascular, Biosensors, Biotronik, Boston Scientific, and Medtronic; and speaker's fees from Abbott Vascular, Biosensors, Biotronik, and Boston Scientific. D.M. is a consultant for Medtronic, Boston Scientific and Microport. D.S., S.C., and K.G.O. are employees of Biosensors. The other authors report no conflicts of interest.
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