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RIBS IV: EES superior to DEB for DES in-stent restenosis
Everolimus-eluting stents yielded superior long-term outcomes compared with drug-eluting balloons for the treatment of patients with drug-eluting stent in-stent restenosis, according to results of the RIBS IV trial.
The randomized trial included 309 patients from 23 hospitals in Spain. A DEB (SeQuent Please, B. Braun Surgical) was used in 154 patients and an everolimus-eluting stent (EES; Xience Prime, Abbott Vascular) in 155 patients.
The primary endpoint was in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. Median follow-up was 247 days in 90% of eligible patients. At late angiography, in-segment minimal lumen diameter was 2.03 ± 0.7 mm in the EES group vs. 1.8 ± 0.6 mm in the DEB group, yielding an absolute mean difference of 0.23 mm (P < .01). Compared with DEB, the EES group also had significantly greater net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; P < .01). EES yielded lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; P < .01) and binary restenosis (11% vs. 19%; P = .06), according to the results published in the Journal of the American College of Cardiology.
In-lesion analysis yielded consistent results across all subgroups for 10 prespecified variables, according to the researchers.
They noted that 100% of the cohort had clinical follow-up data at 1 year. The composite outcome of cardiac death, MI and target vessel revascularization was 10% in the EES group vs. 18% in the DEB group (P = .04). This lower outcome was mainly driven by reduced TVR in the EES group, 8% vs. 16% (P = .035), the researchers wrote. Four patients in the EES group and three in the DEB group died during 1-year follow-up. MI occurred in two patients in the EES group vs. five in the DEB group. Definite stent thrombosis occurred in one patient in the EES group vs. two in the DEB group.
“This study demonstrated the superior efficacy of EES compared with DEB in patients with DES- [in-stent restenosis],” the researchers concluded. “Our findings strongly suggest that EES should be considered the therapy of choice in this vexing and challenging anatomic scenario.” – by Rob Volansky
Disclosure: The RIBS IV study was supported by an unrestricted grant from B. Braun Surgical and Abbott Vascular. One research reports receiving lecture fees from Abbott Vascular. The other researchers report no relevant financial disclosures.