New-Generation EES Show Superiority Over DEBs to Treat DES In-Stent Restenosis

September 14, 2014—The RIBS IV clinical trial comparing the use of everolimus-eluting stents (EES) and drug-eluting balloons (DEBs) in treating in-stent restenosis (ISR) from drug-eluting stents (DES) found that EES provided superior late angiographic results and better late clinical outcomes. The findings were reported by Lead Investigator Fernando Alfonso, MD, at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.

As noted by TCT, when treating patients presenting with DES-ISR, DEBs appear to be as effective as first-generation DES. However, the relative value of DEBs compared to new-generation DES remains unknown. 

RIBS IV is a multicenter, prospective, randomized trial that compared the efficacy of a DEB (Sequent Please paclitaxel-eluting balloon, B. Braun Interventional Systems Inc.) with that of an EES (Xience Prime, Abbott Vascular) in patients with DES-ISR. The trial was an investigator-driven initiative funded by unrestricted grants from B. Braun and Abbot Vascular, advised TCT.

The primary endpoint was minimal lumen diameter at late angiographic follow-up. Secondary endpoints, including diameter stenosis, angiographic late lumen loss, and binary restenosis, were also analyzed at 9 months. 

As summarized in the TCT announcement, the RIBS-IV trial was composed of 309 patients with DES-ISR who were randomized to receive either EES (n=155) or DEBs (n = 154). Late angiographic follow-up was obtained in 90% of eligible patients. At 9 months, the EES group reported a larger in-segment minimal lumen diameter than the DEB group (2.03 vs 1.8, respectively; P = .004). After 1 year, the EES group also reported higher rates of freedom from target lesion revascularization (96% vs 87%; P = .008) and freedom from major adverse coronary events, including cardiac death, myocardial infarction, and target vessel revascularization (90% vs 82%; P = .044). 

Dr. Alfonso commented in the TCT press release, “In patients with DES-ISR, our study found that EES provide superior late angiographic results and better late clinical outcomes compared to DEB. Treatment of DES-ISR remains challenging and associated with poorer clinical and angiographic results than treatment of bare-metal stent ISR. Further studies with more patients and longer follow-up are warranted in this adverse setting.” Dr. Alfonso is the Head of the Cardiac Department at the Hospital Universitario de La Princesa in Madrid, Spain.