RIBS IV: EES Superior to DEB in Patients with In-Stent Restenosis

Everolimus-eluting stents (EES) provide superior late angiographic and clinical results compared with drug-eluting balloons (DEBs) in patients with coronary in-stent restenosis of drug-eluting stents (DES).

Fernando Alfonso, MD, PhD, from Hospital Universitario de la Princesa, Madrid, Spain, presented findings from the RIBS IV trial at TCT 2014. In all, 309 patients with DES in-stent restenosis were randomly assigned second-generation EES (Xience Prime, Abbott Vascular; n=155) or DEB (SeQuent Please, B. Braun; n=154).

Alfonso and colleagues obtained angiographic success in all cases and late angiographic follow-up in 90% of eligible patients. The primary endpoint, defined as in-segment minimum lumen diameter (MLD) at 9-month follow-up, was larger with EES compared with DEB. Alfonso also reported trends favoring EES in terms of binary restenosis and late lumen loss (see Table).

In addition, cumulative frequency distribution curves for in-segment minimum lumen diameter were larger in the EES group after the procedure (P=.04) and through follow-up (P=.004). Further analysis of minimal lumen diameter using 10 prespecified clinical and angiographic variables revealed consistent results favoring EES.

The RIBS IV researchers also obtained 360-day clinical follow-up for 100% of the study population. Patients assigned EES had higher rates of freedom from TLR (96% vs. 87%; P=.008) and freedom from MACE including cardiac death, MI and TVR (90% vs. 82%; P=.044).

Five patients in the DEB group crossed over to stenting, according to Alfonso.

“Treatment of DES in-stent restenosis remains challenging and associated with poorer clinical and angiographic results than treatment of bare-metal stent in-stent restenosis,” Alfonso said at a late-breaking clinical trial session. “Further studies including more patients and longer follow-up are still warranted in this adverse setting.”

Session moderator and TCT Course Director Gregg W. Stone, MD, of Columbia University Medical Center, New York, said DES in-stent restenosis “is a problem that doesn’t occur very often, but when it does, [it’s] a vexing issue with high rates of recurrence with any of our therapies. These results are somewhat different than RIBS V, [which was conducted in patients with] BMS in-stent restenosis. Here, we get very clearly better angiographic results with EES and clearly better clinical event rates. These are fascinating results.”

RIBS IV is the first randomized trial of DEB vs. EES in patients with DES in-stent restenosis. The multicenter trial was conducted at 23 sites in Spain. Baseline characteristics were well balanced between the two groups, Alfonso said. Mean age of enrolled patients was 66 years, and the majority (83%) were men. All patients had DES in-stent restenosis of >50% and angina or silent ischemia. Median time to in-stent restenosis was 547 days.

 Disclosures:

• Alfonso reports no relevant conflicts of interest.

• Stone reports relationships with multiple device companies.