RESTORE ISR China Results Presented for Cardionovum's Drug-Coated Balloon
September 27, 2018—Cardionovum GmbH announced new clinical data from the randomized controlled RESTORE ISR China trial, which evaluated the safety and efficacy of the company's Restore paclitaxel-coated balloon for treating coronary in-stent restenosis (ISR) compared to the Sequent Please drug-coated balloon (DCB) (B. Braun). Primary investigator Yundai Chen, MD, of PLA General Hospital in Beijing, China, presented the data at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California.
The company-sponsored RESTORE ISR CHINA trial was designed to meet Chinese regulatory requirements for the next-generation Restore DCB, which uses the company's SafePax coating matrix.
The trial included 240 patients with coronary ISR at 12 sites in China. The primary endpoint was in-segment late lumen loss of the target lesion 9 months after the procedure.
According to Cardionovum, the performance of the two treatments was statistically indistinguishable. Noninferiority of Restore was proven by a large margin (P = .02). The matching performance of Restore was valid for both in-segment and in-device late lumen loss. Both DCBs also showed statistically similar rates of target lesion failure at 1 year (P = .87 for the difference).
Dr. Chen commented in the company's announcement, "These positive trial results with Restore expand the range of DCB options in our patients with ISR. This is great news to physicians. The safety and maneuverability of Restore are especially relevant in cardiac applications. With Restore, I feel in control of drug delivery to the target site with minimal risk for embolization."