Twelve-Month Ranger DCB All-Comers Registry Data Presented at CIRSE
September 17, 2017—Twelve-month data from an all-comers registry evaluating the Ranger drug-coated balloon (DCB) for peripheral arterial use were presented by Michael K.W. Lichtenberg, MD, at CIRSE 2017 in Copenhagen, Denmark.
The investigator-initiated registry prospectively collected data from 172 femoropopliteal patients (226 lesions) with femoropopliteal disease who were treated with the Ranger DCB at five European centers. The primary efficacy endpoint was primary patency at 12 and 24 months, defined as freedom from restenosis as indicated by duplex ultrasound (peak systolic velocity ratio ≥ 2.4) in the target lesion with no reintervention.
The results presented at CIRSE included a 12-month site-reported primary patency of 84% by Kaplan-Meier analysis, as well as 89% 12-month freedom from target lesion revascularization. The majority of patients were shown to have moved up at least two Rutherford categories, and significant differences were seen in ankle-brachial indices.
In terms of lesion characteristics, the presentation data included an average length of 129 mm (range, 5–400 mm) and percent diameter stenosis of 91% ± 10%. Calcification was predominantly none/low (74%), with 23% having moderate calcification. Nearly half of the lesions included were determined to be TASC II C or D.
Dr. Lichtenberg, of Klinikum Arnsberg in Germany, concluded that the results are in line with those seen in previous analyses of the Ranger DCB. In April, Prof. Dierk Scheinert presented data from a randomized control trial of the Ranger platform at the Charing Cross meeting in London. The Ranger device has CE Mark approval and is available in Europe in both SFA and below-the-knee sizes. The Sterling-balloon-based platform’s TransPax coating includes a 2-µg/mm2 paclitaxel concentration.
Also at CIRSE 2017, data from MAJESTIC trial evaluating Boston Scientific’s Eluvia drug-eluting stent stent system were presented by Prof. Stefan Müller-Hullsbeck.