From the Journals

For in-stent restenosis, everolimus-eluting stents topped drug-eluting balloons

Publish date: May 21, 2018
By
Amy Karon

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Don’t bid DEBs good-bye yet

Three-year outcomes favored everolimus-eluting stents (EES) over drug-eluting balloons (DEBs) for treating in-stent restenosis, but this “should not be a reason to bid farewell to DEBs,” wrote Hyo-Soo Kim, MD, PhD, and Tae-Min Rhee, MD, in an editorial accompanying the study.

Both EES and DEB have excellent long-term safety, so a “simple rivalry between the [two] arms is no longer meaningful,” they wrote in JACC: Cardiovascular Interventions. “Instead, it is time to find ways to improve the efficacy of DEBs.”

The efficacy of DEB depends on the amount of antiproliferative drug delivered to the target lesion, which isn’t the case for EES, the experts noted. In past studies, independent predictors of long-term DEBs success included less than 20% residual stenosis, balloon-to-stent ratio exceeding 0.91, and inflation time above 60 seconds, they added. When all three of these criteria were met, DEBs performed as well as new-generation drug-eluting stents.

Thus, DEBs retains a treatment niche, “particularly for in-stent restenosis lesions already covered with one or more metal layers.”

Dr. Kim and Dr. Rhee are with Seoul (South Korea) National University Hospital. They reported having no conflicts of interest. These comments are from their editorial (JACC Cardiovasc Interv. 2018;11:992-4).


 

FROM JACC: CARDIOVASCULAR INTERVENTIONS

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.

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