DCB designed to prevent arterial trauma effective at 1 year

A novel drug-coated balloon designed to prevent arterial trauma was safe and effective at 1 year, according to results from the ENDURE study presented at VEITHSymposium.

The DCB (Chocolate Touch, QT Vascular/TriReme Medical) is designed for constrained expansion to reduce acute arterial trauma, which can be a problem associated with DCB interventions in patients with peripheral artery disease, Gunnar Tepe, MD, chief of radiology at RoMed Klinikum in Rosenheim, Germany, said during a presentation.

“The balloon uniformly distributes longitudinal and radial forces, reduces exposure to torsional, radial and longitudinal forces that occur during balloon inflation and has ‘pillows’ and ‘grooves’ that facilitate plaque modification without cutting or scoring,” he said. “This reduces vessel trauma, which leads to fewer dissections and reduced need for bailout stenting. It also preserves all options, including stents, for potential subsequent interventions.”

As Cardiology Today’s Intervention previously reported, 6-month results of ENDURE yielded positive safety and efficacy outcomes in 67 patients (mean age, 69 years; range, 53-92 years; 60% men; 70 lesions) with femoropopliteal disease enrolled at four sites in Germany and New Zealand.

Among the cohort, 22.9% had severe calcification and 33.3% had total occlusions.

At 1 year, mean change in ankle-brachial index was 0.29 (range, –0.1 to 1.3) and mean change in Rutherford class was –2.6 (range, –5 to 0), Tepe said.

There were five major adverse events at 1 year: four cases of clinically driven target lesion revascularization, all of which occurred by 6 months, and one death, which occurred between 6 months and 1 year, according to the researchers.

The reported rate of patency at 1 year was 83.6% and the Kaplan-Meier estimate was 89.9%, Tepe said.

“The combination of the Chocolate platform and paclitaxel coating offers the potential to avoid stents almost entirely,” Tepe said during the presentation. “The DCB shows promising evidence of drug effect by way of low late lumen loss and high patency at 12 months.”

He said the FDA has allowed the manufacturer to proceed with an investigational device exemption study in which 510 patients with PAD will be randomly assigned the Chocolate Touch or Lutonix (BD) DCBs. – by Erik Swain

Reference:

Tepe G, et al. Session 26: New Developments in Drug-Coated Balloons, Other Devices for Treatment of Lower Extremity Occlusive Lesions, Randomized Trials and BTK Treatments. Presented at: VEITHSymposium; Nov. 13-17, 2018; New York.

Disclosure: Tepe reports he received research grants from BART, Bayer, B. Braun, Biotronik, Medtronic, Philips, Shockwave Medical, Veryan and W.L. Gore and Associates.