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DEB safe, effective for treatment of side branches in bifurcation lesions
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Use of a new drug-eluting balloon in the side branch after deployment of a drug-eluting stent yielded a low rate of late lumen loss and restenosis at the side branch ostium, according to 6-month angiographic follow-up results of the DEBSIDE trial.
The prospective, nonrandomized, multicenter study included 52 patients with de novo bifurcation lesions at eight centers in France. Between May 2012 and July 2016, all patients underwent DES placement (Nile PAX stent) followed by final DEB inflation (Danubio Balloon, Minvasys), based on size of the side branch. Eligible participants were aged older than 18 years, with clinical evidence of ischemic heart disease, stable/unstable angina with signs of ischemia, silent functional ischemia or a positive functional test. Required lesion length was 6 mm or smaller in the side branch; and the reference vessel diameter had to be 2.5 mm to 3.5 mm for the main branch and 2 mm to 3 mm for the side branch.
The primary endpoint was late lumen loss at the ostium of the side branch at 6 months by quantitative coronary angiography evaluation. Secondary endpoints included angiographic success, late lumen loss in the main branch, angiographic binary restenosis rate in the side and main branches and MACE. Procedure success also was evaluated, with success defined as attaining a stenosis of less than 50% without clinical or ischemic events during index hospitalization. Patients were seen for clinical follow-up at 1, 6 and 12 months, and for an angiographic control at 6 months.
Procedural success was attained in 100% of cases. After the procedure, the mean percentage of the side branch diameter stenosis showed a reduction from 62 ± 14% to 23.9 ± 11.3%. Before the procedure, the mean side branch diameter stenosis was 30 ± 14.5%, and it was reduced to 23.9 ± 11.3% after the procedure. An increase was observed in the mean lumen diameter of the side branch, from 1.36 ± 0.38 mm to 1.52 ± 0.31 mm after the procedure (P = .01), and persisted at 6 months at 1.55 ± 0.36 mm. Also at 6 months, side branch late lumen loss was –0.04 ± 0.34 mm, and main branch late lumen loss was 0.54 ± 0.6 mm.
The researchers observed no in-hospital complications or adverse clinical events up to 30 days, with the exception of a single MI (2%), which was treated with emergency revascularization for an acute occlusion in the target lesion at the stent level. No further MIs occurred. Only one patient had a nonclinically precipitated target lesion revascularization at the level of the side branch combined with a main branch revascularization (2%).
“Restenosis following [DES] implantation in the treatment of bifurcation lesions remains a concern,” the researchers wrote. “The 6-month angiographic results of the DEBSIDE trial show that [DEB] inflation using the Danubio balloon resulted in very low rates of restenosis of the side branch and, while further studies are warranted, its use may be a significant addition to the interventionalist’s armamentarium by avoiding unnecessary side branch stenting in the treatment of all types of bifurcation lesions.” – by Jennifer Byrne
Disclosure: One researcher reports receiving lecture honoraria and consultant fees from Minvasys.
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