Novel DCB improves Rutherford class, other outcomes at 1 year

D. Christopher Metzger

LAS VEGAS — A novel drug-coated balloon conferred improvement in Rutherford class, ankle-brachial index and several measures of walking ability in patients with peripheral artery disease, according to data from a first-in-human study presented at VIVA 18.

The PREVEIL study of the DCB (SurVeil, Surmodics/Abbott) assessed its safety and feasibility in 13 patients with femoropopliteal artery lesions.

As Cardiology Today’s Intervention previously reported, at 6 months, all patients (mean age, 68 years; 69% men; mean lesion length, 56.4 mm) achieved primary patency, most improved in Rutherford class and mean ankle-brachial index and 6-minute walk test score improved.

D. Christopher Metzger, MD, FACC, FSCAI, interventional cardiologist at Wellmont CVA Heart Institute in Kingsport, Tennessee, presented 1-year results here.

“This is a different-looking drug-coated balloon,” Gary M. Ansel, MD, FACC, system medical chief for vascular at OhioHealth in Columbus and a Cardiology Today’s Intervention Editorial Board Member, said at a press conference on behalf of Metzger. “It’s a much more uniform application process for the paclitaxel, even when you expand it, compared to the other drug-coated balloons currently on the market.”

Gary M. Ansel

At 12 months, no patients had evidence of paclitaxel toxicity, major vascular complications, TIMI-defined bleeding, target lesion revascularization, target vessel revascularization, arterial thrombosis or embolic events, Metzger said.

The previously reported primary endpoint of peak paclitaxel plasma concentration at 30 days was 2.25 ng/mL (area under the curve, 3.74), lower than that seen in two existing DCBs, Lutonix 035 (BD/Bard) and IN.PACT Admiral (Medtronic).

At 1 year, Rutherford class improved by three grades in 61.5% of patients, by two grades in 21.1% of patients and by one grade in 7.7% of patients, according to the researchers.

Ankle-brachial index at 1 year improved by a mean of 0.19 and a median of 0.13 (P = .046), whereas 6-minute walk distance improved by a mean of 320.8 m and a median of 350 m (P = .102), Metzger said.

At 1 year, the following Walking Impairment Questionnaire scores improved: Walking Distance Score (mean, 50.72; median, 65.48; P = .003), Walking Speed Score (mean, 28.09; median, 32.61; P = .045) and Stair Climbing Score (mean, 36.33; median, 50; P = .008), Metzger and colleagues found.

“The device met secondary performance criteria, both in terms of device and procedural success,” Ansel said at the press conference. “We have shown Rutherford class improvement in more than 92% of patients, and 100% freedom from TLR as well.” – by Erik Swain

Reference:

Metzger DC, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.

Disclosures: The study was funded by SurModics. Ansel reports he has financial ties with Abbott Vascular, Bard Peripheral Vascular, Best Doctors, BioCardia, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Intact Vascular, Lake Region, Medtronic, Ostial Solutions, Philips, Reflow Medical, ROX Medical, Shockwave Medical, SoundBite Medical, SurModics, Veryan/Novate, Vessix Vascular, VIVA Physicians and W.L. Gore and Associates. Metzger reports he has received honoraria from Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc., Cordis, Medtronic, TriVascular and W.L. Gore and Associates.