Research examining 278 patients with in-stent restenosis (ISR) found that drug-eluting balloon (DEB) was non-inferior in comparison with drug-eluting stent (DES) in terms of six-month minimal lumen diameter (MLD).
The results were presented by José P.S. Henriques, MD, PhD, on Oct. 30 at the 29th annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Denver. The research was concurrently published in the JACC: Cardiovascular Interventions.
“This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside of each other,” said Henriques, MD, PhD, with University of Amsterdam. “That just becomes a self-perpetuating problem, so the ability to treat these patients reasonably well without putting in more stents is a tremendous advantage in the long run.”
The multicenter randomized non-inferiority trial included patients with any ISR. The 278 individuals were randomly allocated in a 1:1 fashion to treatment with a SeQuent Please paclitaxel-eluting balloon (BBraun) or a XIENCE everolimus-eluting stent (Abbott Vascular).
DES treatment showed larger in-segment MLD (1.84 mm to 1.72 mm) and lower percent stenosis (26 percent to 30 percent). Those disparities were counterbalanced by late lumen loss in the DES group (0.45 to 0.17 millimeters) at six months.
Other clinical events, such as death, MI or stroke, occurred at similar rates.
“In patients with ISR, treatment with DEB was non-inferior compared with DES in terms of six-month minimal lumen diameter,” wrote Henriques and colleagues in JACC. “There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for ISR which negates the need for additional stent implantation.”