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Design and rationale of a prospective, randomized, non-inferiority ...pdf (1.12 MB)

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)

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posted on 2023-07-19, 16:53 authored by Bryan P Traynor, Sean FitzgeraldSean Fitzgerald, Fernando Alfonso, Peter O'Kane, Manel Sabaté, Ralph Tölg, Jasper Trevelyan, Joo-Yong Hahn, Darren Mylotte, Jochen Wöhrle, Himanshu RaiHimanshu Rai, Bernardo Cortese, Marie-Claude Morice, Diane Schuette, Samuel Copt, Keith G Oldroyd, Robert ByrneRobert Byrne, REFORM investigators

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.

Funding

Biosensors Europe S.A., Morges, Switzerland.

History

Comments

The original article is available at https://www.sciencedirect.com/

Published Citation

Traynor BP. et al. 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). Cardiovasc Revasc Med. 2023;56:75-81.

Publication Date

6 June 2023

PubMed ID

37328392

Department/Unit

  • School of Pharmacy and Biomolecular Sciences

Publisher

Elsevier

Version

  • Published Version (Version of Record)