For patients with coronary artery restenosis at the site of a drug-eluting stent, placing an everolimus-eluting stent was associated with a 57% lower risk of target lesion revascularization, compared with placing a drug-eluting balloon.
At 3-year follow-up in the randomized, multicenter RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial, 7.1% of patients required target lesion revascularization after EES versus 15.6% of patients after DEB (P = .015), reported Fernando Alfonso, MD, of Hospital Universitario de La Princesa, Madrid, and his associates. Consequently, the combined rate of cardiac death, myocardial infarction, and target lesion revascularization was 12.3% with EES versus 20.1% with DEB (hazard ratio, 0.57; 95% confidence interval, 0.34-0.96; P = .04). The findings were reported in JACC: Cardiovascular Interventions.
About 5%-10% of patients who receive a drug-eluting stent (DES) develop in-stent restenosis (ISR). When this happens, robust data support placing a DEB or next-generation DES, such as an EES, instead of a conventional (plain) balloon, the investigators noted. To directly compare EES versus DEB, they randomly assigned 309 patients with at least 50% lumen diameter stenosis at the DES site or involving its 5-mm edge to receive either DEB (SeQuent Please, B. Braun) with a 1.1:1 balloon-to-artery ratio (mean 18 atm [pressure]), or EES (Xience Prime, Abbott Vascular) with the same final ratio but significantly greater deployment pressure (mean 20 arm; P = .001). All patients had angina or objective evidence of ischemia without stent thrombosis, and the trial arms otherwise resembled each other clinically and demographically.
Angiography documented 100% immediate procedural success in both groups. At 1 year, rates of target lesion revascularization were 4.5% with EES and 13% with DEB, a significant difference (HR, 0.33; 95% CI, 0.14-0.79). Similarly, rates of target vessel revascularization were 8.4% and 16.2%, respectively (HR, 0.49; 95% CI, 0.25-0.97), at year 1 and 11% and 20.8%, respectively, at year 3 (HR, 0.50; 95% CI, 0.28-0.90).
Throughout the study, including at 3 years, the groups had similar rates of cardiac death (3.9% for EES vs. 3.2% for DEB), MI (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%). “Results of other composite clinical outcomes [also] were very similar,” the researchers wrote. While “both DEB and EES provide favorable long-term clinical outcomes,” patients “receiving EES benefit[ed] from a better long-term clinical outcome, mainly driven by a reduced need of target lesion and target vessel revascularization.”
Funders of the study included B. Braun and Abbott Vascular. The investigators reported having no conflicts of interest.
SOURCE: Alfonso F et al. JACC Cardiovasc Interv. 2018;11:981-91.