Findings Published for RIBS IV Study Comparing DEBs and EESs

June 29, 2015—Findings from the prospective, randomized RIBS IV clinical trial were published by Fernando Alfonso, MD, et al in the Journal of the American College of Cardiology (JACC; 2015;66:23–33).

RIBS IV evaluated the comparative efficacy of drug-eluting balloons (DEBs) versus everolimus-eluting stents (EESs) in patients presenting with DES in-stent restenosis (DES-ISR). In patients with DES-ISR, EESs provided superior long-term clinical and angiographic results compared with DEBs, concluded the investigators in JACC.

Dr. Alonso, the trial’s lead investigator, presented the findings in September 2014 at the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The Transcatheter Cardiovascular Therapeutics announcement noted that the devices compared in RIBS IV were the Sequent Please paclitaxel-eluting balloon (B. Braun Interventional Systems Inc.) and the Xience Prime EES (Abbott Vascular). The trial was an investigator-driven initiative funded by unrestricted grants from B. Braun and Abbott Vascular.

The study design of this multicenter randomized clinical trial assumed superiority of EESs for the primary endpoint of in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up.

As summarized in JACC, the trial was conducted at 23 university hospitals in Spain, where 309 patients with DES-ISR were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median, 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs 1.8 ± 0.6 mm), net lumen gain (1.28 ± 0.7 mm vs 1.01 ± 0.7 mm), lower percent diameter stenosis (23 ± 22% vs 30 ± 22%) and binary restenosis rate (11% vs 19%) compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. 

At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs 18%), mainly driven by a lower need for target vessel revascularization (8% vs 16%), reported the investigators in JACC.