ISAR-DESIRE 4, which is the first trial to examine the role of lesion preparation before using drug-coated balloons, indicates that the use of a scoring balloon may enhance the efficacy of drug-coated balloons to treat in-stent restenosis. The study was presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting (11–15 October, San Francisco, USA).
The trial examined a patient population with in-stent restenosis following limus-eluting stent implantation. Investigators sought to determine whether treatment of in-stent restenosis is more effective when the lesion is prepared by means of scoring balloon prior to drug-coated balloon therapy with Pantera Lux (Biotronik).
In the study, 250 patients were randomised into two study arms—after lesion preparation with either standard uncoated balloon predilatation or scoring balloon, both groups were treated with Pantera Lux. The primary endpoint was percent diameter stenosis at six to eight months. Though primary endpoint outcomes for the SCB group were slightly improved (35%DS v. 40%DS, p=0.047), a Biotronik press release reports, drug-coated balloon treatment with Pantera Lux effected overall positive clinical outcomes for both.
Robert Byrne, German Heart Center, Munich, Germany, who presented the data at TCT, says “Though previous trials have shown very positive outcomes for DCB in treating in-stent restenosis, little was known as to whether lesion preparation would have any influence on the outcome. ISAR- DESIRE 4 further establishes drug-coated balloon as a valuable tool to treat in-stent restenosis, independent of the type of lesion preparation. In the most challenging cases seen in this trial, it appears that Pantera Lux’s performance can be even further enhanced by using scoring balloon predilatation. These benefits are likely caused by better drug uptake due to micro-injuries created by the scoring balloon.”