Use of biolimus-coated balloons during PCI not as effective as paclitaxel devices
Using a biolimus-coated balloon (BCB) to prevent coronary in-stent restenosis after percutaneous coronary intervention (PCI) may not be as effective as a paclitaxel-coated balloon (PCB), according to a new randomized clinical trial published in JACC: Cardiovascular Interventions.[1]
The REFORM trial included outcomes data from more than 200 patients who underwent PCI from August 2020 to July 2022 in one of six different countries.
Two patients were treated with a BCB for every one patient treated with a PCB. BCB patients were treated with the new Biolimus A9 Coated BioAscend balloon. That device’s coating, Biolimus A9 (BA9), was developed by Biosensors International. PCB patients, on the other hand, were treated with the SeQuent Please device from B. Braun Melsungen.
In both groups, the mean patient age was approximately 68.5 years old and a majority of patients were men. Slightly more PCB patients presented with a history of stroke, and BCB patients were more likely to present with a history of coronary artery bypass graft surgery. But all other patient characteristics were similar when comparing the two groups.
The study’s primary outcome, in-segment percentage diameter stenosis after six months, was seen in 43.3% of BCB patients and 31.4% of PCB patients. Target lesion failure after one year, meanwhile, was seen in 23.7% of BCB patients and 17.1% of PCB patients. Researchers concluded that the BCB was not noninferior to the PCB.
“The reason for the inferior efficacy of the investigational device is not known, but is most likely due to poor transfer efficiency or tissue retention of the biolimus drug-coated on the balloon,” wrote first author Robert A. Byrne, MBBCh, PhD, a researcher with the RCSI University of Medicine and Health Sciences in Dublin, Ireland, and colleagues. “This may be related to the nature of the crystalline formulation of the drug and microparticle size of the surface coating matrix on this iteration of the investigational device. The clear results of our study suggest against testing the current device iteration in larger patient cohorts or for other therapeutic indications.”
A similar study produced different results
In 2024, researchers exploring this same topic concluded that PCI with a BCB was noninferior to PCI with a PCB. That trial was known as BIO ASCEND ISR, and its authors published their initial results in EuroIntervention.[2]
Why did these two trial result in different conclusions? Byrne et al. considered that very question.
“There are several possible explanations for the variation in primary results between REFORM and BIO ASCEND ISR,” they wrote. “The most important is that device design differed between the trials, with a newer generation device used in the latter trial, with smaller crystalline particle size, which may have contributed to higher drug transfer and retention. Other differences include differences in sample size, follow-up period, and types of in-stent restenosis, with only drug-eluting stent in-stent restenosis lesions included in BIO ASCEND ISR.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.