ISAR DESIRE 4: Paclitaxel-coated balloon is safe in treating in DES restenosis
The use of a scoring balloon plus a paclitaxel-coated balloon yielded angiographically superior results vs. a paclitaxel-coated balloon alone in patients with restenosis with limus-eluting stents, according to findings from the ISAR DESIRE 4 trial presented at the annual TCT scientific symposium.
“In the ISAR DESIRE 4 trial, we showed in patients presenting with DES restenosis in limus-eluting stents, that paclitaxel-coated balloon-based strategies confirmed a high clinical safety profile out to one year,” Robert A. Byrne, PhD, of Deutsches Herzzentrum, Munich, Germany, said in a presentation.
“Moreover, neointimal modification with scoring balloon significantly improves the angiogenic, anti-restenotic efficacy of paclitaxel-coated balloon angioplasty,” he said.
In the prospective, randomized, active-controlled, multicenter trial, Byrne and colleagues evaluated 252 patients with drug-eluting stent implantation restenosis enrolled between June 2012 and December 2014 from four sites in Germany.
The researchers randomized patients to either treatment with scoring balloon plus paclitaxel-coated balloon (n = 125) or paclitaxel-coated balloon alone (n = 127). A total of 203 patients (80.4%) were seen for angiographic follow-up at 6 to 8 months. Clinical follow-up took place at 12 months.
There were no significant differences between groups in baseline clinical or demographic characteristics. The study’s primary endpoint was percent diameter stenosis on angiographic follow-up. Secondary endpoints included binary restenosis, target lesion revascularization, death/MI and target lesion thrombosis.
The percent diameter stenosis was 40.4% ± 21.4% in the scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) group compared with 35% ± 16.8 for the PCB alone group (P = .047). With SCB plus PCB, patients also had lower rates of binary restenosis than with PCB alone (18.5% vs. 32%, P = .03).
Similar rates were seen between the SCB plus PCB and PCB alone groups in target lesion revascularization (16.8% vs. 22.6%, respectively, P = .25) and death/MI (3.3% vs. 3.4%, respectively, P > .99).
“In terms of further safety endpoints, such as target lesion thrombosis, there were no events in either group — zero percent with both scoring balloons and control therapy,” Byrne said. – by Jennifer Byrne
Byrne RA. Neointimal Modification in Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients with Restenosis in Drug-Eluting Coronary Stents. Presented At: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Disclosure: Byrne reports receiving lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific.