Data presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA) indicates that the performance of Restore (Cardionovum) matches that of latest-generation zotarolimus-eluting stent (Resolute, Medtronic) in patients with coronary small vessel disease. The data were presented by Runlin Gao (Fuwai Hospital, Chinese Academy of Medical Science, China).
The trial was performed at 12 sites, enrolling 262 patients with coronary small vessel lesions. Patients were treated with the Restore paclitaxel-releasing drug-coated balloon or the Resolute stent. The primary analysis was non-inferiority of Restore on percent diameter restenosis at nine months. This objective was met with high statistical significance (<0.001). There were also statistically similar rates of target-lesion failure at one year.
The trial included a substudy in patients with very small vessels (diameter between 2mm and 2.25mm). Restore was successfully employed in this population with a procedural complication rate of only 3% and no death, myocardial infarction or thrombotic events. A press release reports that these findings make Restore the first drug-coated balloon with safety and angiographic efficacy evidence from a randomised controlled clinical trial in this vulnerable population. Currently, interventional cardiologists have few proven treatment options for very small diseased vessels.
Gao comments: “Our results add to the growing body of evidence of the benefit of drug-coated balloon treatment in small vessel disease. The non-inferiority was met in percentage of diameter restenosis compared to RESOLUTE and the clinical results were also comparable between the two groups. This provides the physicians with a new clinical option for the treatment of small vessel disease and the concept of ‘intervention without implantation’ could possibly be beneficial to the small vessels.”
Enrolment into RESTORE SVD took only 10 months, which minimised the risk of bias and ensured that both treatment groups received up-to-date therapies. In the comparator group all patients were treated with the latest-generation zotarolimus-eluting stent. Angiographic data were available for >80% of the study population.
Marina Izzo, CEO of Cardionovum, comments: “I am very impressed by the stellar team of researchers who designed and carried out RESTORE SVD. For drug-coated balloon and Restore to become established as an option in small vessel disease, evidence has to be of supreme quality. The RESTORE SVD trial met the highest international standards. Angiographic assessments were performed by an independent core lab including for patients with very small vessels. At Cardionovum we believe passionately in our products and we are confident that physicians and patients will soon benefit from the results of this trial.”
According to the press release, Restore is a next-generation drug-coated balloon that uses the proprietary Safepax next-generation coating matrix with the smallest particle size and highest coating stability on the market. It has demonstrated high success rates and excellent safety profile in coronary applications.