PREVEIL: Novel DCB shows feasibility in first-in-human study

Gary M. Ansel

A first-in-human trial of a novel drug-coated balloon showed technical and performance success, according to findings presented at VIVA 17.

Gary M. Ansel, MD, FACC, system medical chief for vascular at OhioHealth in Columbus and a Cardiology Today’s Intervention Editorial Board Member, and colleagues conducted PREVEIL, a prospective, multicenter, single-arm trial, to assess safety and feasibility of the DCB (SurVeil, Surmodics) in 13 patients with de novo lesions in the femoropopliteal artery.

The study was conducted under an FDA program incentivizing companies to perform first-in-human clinical studies in the United States, Ansel said.

“While this was a feasibility trial, it showed a best-in-class right-now late lumen loss improvement,” Ansel told Cardiology Today’s Intervention. “It’s hard to compare trials, but we’re certainly excited about that. The coating of the device is uniform, yet we’re seeing low drug concentrations systemically after the delivery of the device. It looks like a safe and, early on, an effective device. We’re looking at this as the next generation of DCBs.”

The primary endpoint was peak paclitaxel plasma concentration at 30 days. Key secondary endpoints included primary patency at 6 months, late lumen loss at 6 months and freedom from evidence of paclitaxel toxicity, major vascular complications or TIMI major or minor bleeding.

The DCB administered a paclitaxel dose of 1.3 mg to 3.8 mg and peak paclitaxel plasma concentration was 2.25 ng/mL (area under the curve, 3.74), lower than that seen in two existing DCBs, Lutonix 035 (Bard Peripheral Vascular) and IN.PACT Admiral (Medtronic), Ansel said.

Between baseline and 6 months, there were no cases of paclitaxel toxicity, major complications, TIMI major or minor bleeding, target lesion revascularization, target vessel revascularization, arterial thrombosis or embolic events, he said.

At 6 months, Rutherford classification was improved markedly in 69.2% of patients; for the remainder, it improved moderately, according to the researchers.

Ankle-brachial index improved by 0.28 (median, 0.16; P < .001) and 6-minute walk test improved by 90.37 m (median, 115; P = .032) at 6 months, Ansel said.

Primary patency was achieved in all patients, with no cases of restenosis or TLR at 6 months, he said.

Late lumen loss was 0.27 mm (95% CI, –0.06 to 0.59), according to the researchers.

“Technical, device and performance criteria were achieved,” Ansel said during a presentation. “The technology will now move into an [investigational device exemption] trial.” – by Erik Swain

Reference:

Ansel GM, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.

Disclosure: The study was funded by Surmodics. Ansel reports he receives honoraria from Bard Peripheral Vascular, Cook Medical, Cordis and Medtronic; and consults for 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, Best Doctors, Boston Scientific, Cardinal Health, Cook Medical, Cordis, Ostial, Reflow Medical, Philips, Shockwave Medical, Surmodics, Veryan/Novate and W.L. Gore and Associates.