DCB may benefit patients with complex femoropopliteal lesions

Patients with long lesions, calcified lesions or chronic total occlusion who were treated with a drug-coated balloon for femoropopliteal disease experienced high patency rates and few target lesion revascularizations, according to results presented at the Charing Cross Symposium.

“This is interesting because before the presentation everyone was dissuaded to use the catheter balloon in such a complex patient population, but we know that these are also the most frequent patients that we have to treat in our area, so after the presentation, now everyone can be more confident using the [DCB] on long total occlusions and also for severe calcified lesions,” Fabrizio Fanelli, MD, EBIR, professor of radiology at the Sapienza University in Rome, told Cardiology Today’s Intervention.

Researchers analyzed data from 72 patients (mean age, 74 years; 68% men) from the IN.PACT GLOBAL cohort treated with a DCB (IN.PACT Admiral, Medtronic) who had lesions longer than 15 cm (mean length, 24.73 cm) and CTOs.

Fabrizio Fanelli

Primary patency was defined as freedom from clinically driven TLR and laboratory-assessed restenosis at 12 months. Primary safety endpoints included freedom from procedure- and device-related mortality at 30 days and freedom from major target limb amputation and target vessel revascularization at 1 year. Major adverse events included a composite of major target limb amputation, clinically driven TVR, thrombosis and death.

Researchers found that 88.8% of patients achieved primary patency according to Kaplan-Meier analysis. A small percentage of patients (8.5%) had clinically driven TLR at 1 year, and 51.4% of patients received provisional stenting.

Most patients (91.5%) met primary safety endpoints. Major adverse events occurred in 11.9% of patients.

“This is impressive ... especially if you compare to the results of other studies performed with the catheter balloon in less complicated or less severe patient population,” Fanelli told Cardiology Today’s Intervention. – by Darlene Dobkowski

Reference:

Fanelli F, et al. Drug-coated balloon consensus update. Presented at: Charing Cross Symposium; April 25-28, 2017; London.

Disclosure: The study was funded by Medtronic. Fanelli reports speaking for and receiving grants/research support, and honoraria/travel support from Bayer, Bolton, Boston Scientific, Cook, Cordis, C.R. Bard, EV3/Covidien, Medtronic, Philips-Volcano, Shockwave, Spectranetics and W.L. Gore and Associates.