ISAR-DESIRE 4: Scoring Balloon Predilation Effective at 1 Year in Patients With DES Restenosis
In patients with restenosis in limus-eluting stents, predilation with a scoring balloon before use of a paclitaxel-coated balloon is associated with positive outcomes, according to data from the ISAR-DESIRE 4 study presented at TCT 2015.
For the study, which was investigator-initiated but partially funded by Biotronik, Robert A. Byrne, MB, BCh, PhD, of Deutsches Herzzentrum München, in Munich, Germany, and colleagues randomized 252 patients (mean age, 69.4 years) with stenosis > 50% in a limus-eluting stent as well as symptoms or signs of ischemia. More than three-quarters had focal in-stent restenosis, and nearly one-quarter presented with ACS. After pre-dilation, with a scoring balloon (AngioSculpt, AngioScore/Spectranetics) or standard balloon, all were treated with a paclitaxel DCB (Pantera Lux, Biotronik).
The percentage of stenosis after the procedure was similar in both groups (scoring-balloon group, 21.6%; control group, 22.3%), as was postprocedural mean lumen diameter (scoring-balloon group, 2.37 mm; control group, 2.28 mm).
Diameter stenosis at 6- to 8-month follow-up angiography (primary endpoint) was lower in the scoring balloon group than in those assigned predilation with a standard balloon (Figure).
The scoring-balloon group also had a lower rate of binary restenosis compared with the control group (18.5% vs. 32%; P = .03).
Rates at 1 year of target lesion revascularization (scoring-balloon group, 16.8%; control group, 22.6%; P = .25) and death/MI (scoring balloon group, 3.3%; control group, 3.4%; P > .99) did not significantly differ between the groups. There were no cases of target lesion thrombosis.
Enhancing balloon therapy
“We know that drug-coated balloon angioplasty for the treatment of drug-eluting stent restenosis has demonstrated encouraging results in the setting of randomized controlled trials, and [it] has the advantage of avoiding additional stent layers in the restenotic lesions,” Byrne said. “The efficacy of drug-coated balloon treatment relies on rapid initial drug transfer, usually in the setting of a 30- to 60-second balloon dilatation, and tissue retention of the antiproliferative drug. We hypothesized that neo-intimal modification with a scoring balloon predilatation might enhance the efficacy of drug-coated balloon therapy.”
Results from ISAR-DESIRE 4 demonstrate “that in patients presenting with DES restenosis in limus-eluting stents, that paclitaxel-coated balloon-based strategies confirmed a high clinical safety profile out to 1 year,” he concluded. “Moreover, neointimal modification with [a] scoring balloon significantly improves the angiographic antirestenotic efficacy of [paclitaxel-coated balloon] angioplasty.”
- Byrne reports receiving lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific.