Randomised trial of biolimus DEB for in-stent restenosis: the REFORM study

Reviewer: Dr. M. Fatih Kaleli

Presentation:EUROPCR 2023

Background

Restenosis can be observed at a rate of 3-5% per year in percutaneous coronary interventions with drug-eluting stents (DES). According to the guidelines, when this situation is encountered, revascularization with a new DES or drug-coated balloon (DCB) are required. Paclitaxel has been the primary drug utilized in most drug-coated balloons (DCBs). However, in this particular trial, they have investigated the effectiveness of a novel biolimus-coated balloon. This study has the importance of being the first study in terms of the use of 1st generation Biolimus A9TM-coated balloons in patients with in-stent restenosis.

Method

The study was conducted prospectively, multicenter, international and randomized. In this study, it was aimed to show the safety and efficacy of Biolimus A9TM coated balloons (BCB) compared to paclitaxel coated balloon (PCB) use in coronary in-stent restenosis. 202 patients from 20 different centers and 6 different countries were included in the study. Patients randomly assigned in a 2:1 ratio to receive either a biolimus-coated balloon (BCB) or a paclitaxel-coated balloon (PCB) as part of the treatment. The study primary endpoint was determined as the percent diameter stenosis (DS) on coronary angiography performed 6 months after the procedure. Control angiographies were performed in angiography centers blinded to the centers administering the treatment. The standard deviation of the study was 20% and the non-inferiority margin was 12%.

Result

According to the angiography follow-ups performed 6 months later, the percent diameter stenosis (%DS) was 42.7% in the BCB arm and 27.34% in the PCB arm in the stent that was operated p< 0.0001. In-stent restenosis revascularization with BCB does not show non-inferiority in 6-month follow-up compared to PCB.

Interpretation

When the subgroup analysis of the BCB group is examined, it is seen that the parameters that may cause restenosis risk such as male gender, BMI, diabetes, hypertension and coronary by-pass history are at a higher rate than the PCB arm. This may partly explain the excess percent diameter stenosis in the BCB group. Target lesion and target vessel loss were determined as the secondary endpoint of the study. It was stated that the secondary endpoint would be evaluated in 1-6-12-24 month periods and the data would be shared at the end of 24 months. The secondary endpoints of the study will be important in terms of the use of new technologies in cases of in-stent restenosis.