Both everolimus-eluting stents (EES) and drug-eluting balloons (DEB) are safe and effective in patients treated for bare-metal stent (BMS) in-stent restenosis, according to follow-up data from the RIBS V clinical trial (Restenosis Intra-Stent of Bare Metal Stents: Drug Eluting Balloon vs Everolimus-Eluting Stent Implantation).
In the original trial, investigators sought to compare long-term efficacy of EES and DEBs in this specific patient population. As they noted in their paper published in JACC: Cardiovascular Interventions, “The therapy of choice for patients presenting with ISR [in-stent restenosis] remains unsettled.”
A total of 189 patients with BMS in-stent restenosis received either EES (n=94) or DEB (n=95) with follow-up at 1, 2, and 3 years. Patients treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up, compared with patients treated with DEB. Any type of BMS developing in-stent restenosis was eligible for inclusion; however, patients with in-stent restenosis in small vessels (≤2.0 mm in diameter), long lesions (>30 mm in length), or total occlusions were excluded.
While rates of cardiac death, myocardial infarction, and target vessel revascularization were similar between both groups, it is important to note that at 3 years, the rate of target lesion revascularization was significantly lower in the EES group (2% vs 8%; P=.04; hazard ratio: 0.23; 95% confidence interval : 0.06-0.93) compared with the DEB group. Late target vessel and target lesion revascularizations (>1 year) were low in both arms (3.2% vs 3.2%; P=.95 and 1% vs 2.1%; P=.54, respectively). Definite or probable stent thrombosis was also similar between the 2 groups (1% vs 0%).
In addition, at 3 years, 90% of patients in the DEB group and 89% of patients in the EES group were on aspirin while a small number were on dual-antiplatelet therapy (19% in DEB and 27% in EES; P=.12). Major bleeding was also low in both groups and no episodes of “very late stent thrombosis” occurred.
“This is the first study comparing the very long-term results obtained with DEB and EES in patients with ISR,” researchers wrote. “Our findings suggest that in patients with BMS ISR, both strategies are safe and effective at 3-year clinical follow-up. Indeed, episodes of target lesion and target vessel revascularization were very low and comparable in both groups.”
While both EES and DEB appear to have similar efficacy and safety in patients with BMS in-stent restenosis, investigators cautioned that the significant reduction seen in target lesion revascularization with EES should be confirmed in larger studies.
Alfonso F, Perez-Vizcayno MJ, del Blanco BG, et al; for the RIBS V Study Investigators. Long-term results of everolimus-eluting stents vs drug-eluting balloons in patients with bare-metal in-stent restenosis. 3-year follow-up of the RIBS V clinical trial. JACC Cardiovasc Interv. 2016;9(12):1246-1255. doi: 10.1016/j.jcin.2016.03.037.