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Randomized Controlled Trial
. 2025 Mar 10;18(5):654-662.
doi: 10.1016/j.jcin.2024.11.026. Epub 2025 Feb 5.

Randomized Trial of Biolimus DCB for In-Stent Restenosis: The Primary Results of the REFORM Study

Robert A Byrne  1 , Joo-Yong Hahn  2 , Peter O'Kane  3 , Manel Sabaté  4 , Ralph Toelg  5 , Samuel Copt  6 , Sean Fitzgerald  7 , Marie-Claude Morice  8 , Jasper Trevelyan  9 , Darren Mylotte  10 , Antonio Fernandez Ortiz  11 , Himanshu Rai  7 , Rory Durand  7 , Jochen Wöhrle  12 , Franz Xever Kleber  13 , Giuilo Stefanini  14 , Fernando Alfonso  15
Affiliations
Randomized Controlled Trial

Randomized Trial of Biolimus DCB for In-Stent Restenosis: The Primary Results of the REFORM Study

Robert A Byrne et al. JACC Cardiovasc Interv. .

Abstract

Background: In recent years, drug-coated balloon (DCB) angioplasty has become an established treatment option for the treatment of coronary in-stent restenosis (ISR).

Objectives: The aim of this study was to compare the angiographic and clinical performance of the Biolimus A9-coated balloon (BCB; Biosensors Europe) with that of the paclitaxel-coated balloon (PCB; SeQuent Please, Braun Melsungen).

Methods: REFORM (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) was a multicenter, assessor-blinded, noninferiority, 2:1 randomized controlled trial comparing the BCB and the PCB for the treatment of coronary ISR. The primary endpoint was in-segment percentage diameter stenosis at 6 months. Secondary endpoints included target lesion failure. The trial was registered prospectively at ClinicalTrials.gov (NCT04079192).

Results: A total of 202 patients were randomized at 20 centers in 6 countries, with 135 in the BCB group and 67 in the PCB group. The mean patient age was 68.5 ± 10 years. At 6 months, in-segment percentage diameter stenosis was 43.3% ± 22.9% in the BCB group compared with 31.4% ± 17.7% in the PCB group (95% CI for the difference: 4.9%-18.8%; prespecified noninferiority margin 12%, noninferiority P = 0.48). At 1 year, target lesion failure was observed in 23.7% of patients in the BCB group vs 17.1% in the PCB group (HR: 1.44; 95% CI: 0.72-2.88; P = 0.28).

Conclusions: In patients with ISR, the REFORM study failed to demonstrate noninferiority of the investigational biolimus DCB compared with the standard paclitaxel DCB.

Keywords: drug-coated balloon; in-stent restenosis; percutaneous coronary intervention; randomized.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by Biosensors Europe. Dr Byrne has received research or educational funding to the institutions of employment from Abbott Laboratories, Biosensors International, Boston Scientific, and Translumina, without impact on personal remuneration. Dr Hahn has received research funding to the institutions of employment from Abbott Laboratories, Biosensors International, Biotronik, Boston Scientific, Daiichi-Sankyo, and Medtronic. Dr Sabaté has received consultant fees from iVascular and Abbott Laboratories, not related to the reported trial. Dr Mylotte is a consultant for Medtronic, MicroPort, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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