DEB Shows Noninferiority to DES in Patients With In-Stent Restenosis

October 30, 2017—The DARE multicenter randomized clinical trial was presented at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 30 to November 2 in Denver, Colorado. DARE sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with in-stent restenosis (ISR). The findings were presented as a First Report session at TCT and simultaneously published by Jan Baan Jr., MD, et al online ahead of print in Journal of the American College of Cardiology: Cardiovascular Interventions.

As summarized in the TCT announcement, a total of 278 patients (56% with DES-ISR) were randomized at eight sites to treatment with DEB (n = 141) or DES (n = 137).

As compared with DEBs, DESs were associated with larger minimal lumen diameter and lower percent stenosis immediately postprocedure (1.84 ± 0.46 vs 1.72 ± 0.35; P = .018 and 26 ± 10% vs 30 ± 10%; P = .03). Angiographic follow-up was completed at 196 ± 53 days in 79% of patients.

With respect to the primary endpoint of in-segment minimal lumen diameter at 6 months, DEB was noninferior to DES (DEB, 1.71 ± 0.51 mm vs DES, 1.74 ± 0.61 mm; P_{noninferiority} < .0001), with a lesser degree of late loss compared to DES (0.17 ± 0.41 vs 0.45 ± 0.47; P < .001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES, 7.1% vs DEB, 8.8%; P = .65).

Jose P.S. Henriques, MD, commented in the TCT announcement, “In this largest trial of DEBs versus DESs for any ISR to date, the use of a DEBs was noninferior in terms of in-segment minimal lumen diameter at 6-month follow-up. Future research is warranted to investigate the safety and efficacy of the DEB as compared to the DES for ISR in adequately powered, large-scale randomized clinical trials.” Dr. Henriques is Head of the Catheterization Laboratory at the Academic Medical Center, University of Amsterdam in Amsterdam, The Netherlands.