ILLUMENATE Global: DCB for femoropoliteal lesions safe, effective at 2 years

A drug-coated balloon designed for the treatment of femoropopliteal lesions was safe and effective at 2 years in a real-world cohort, according to results presented at the Leipzig Interventional Course.

To assess safety and performance of the DCB (Stellarex, Spectranetics) in the superficial femoral or popliteal arteries, Thomas Zeller, MD, from the department of angiology at the University Heart Center Freiburg-Bad Krozingen in Germany, and colleagues enrolled 371 patients in a prospective, multicenter, single-arm study.

The primary safety outcome of the study was freedom from device and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months, and the primary efficacy outcome was primary patency at 12 months. Zeller presented the 2-year results.

According to the presentation, patients were included in the study if they were Rutherford class 2, 3 or 4, had superficial femoral artery or popliteal lesions, had at least one patent runoff below-the-knee, one or two target lesions with cumulative length up to 20 cm or target vessel reference diameter 4 mm to 6 mm.

At 2 years, there was a 72.4% primary patency rate and 85.3% freedom from clinically driven TLR in the cohort, Zeller said, noting that the patency rate was consistent with that seen in randomized controlled trials of the device.

All-cause mortality at 2 years was 2.7%, he said.

Zeller also said, at 2 years, 86.9% of patients had an improved Rutherford classification and 78.4% had a better walking impairment questionnaire score.

“The results confirm that a low-dose, next-generation DCB can deliver sustained patency,” Zeller said during the presentation. “These outcomes build on the robust ILLUMENATE program data set, demonstrating consistent and durable outcomes with the Stellarex DCB.” – by Dave Quaile

Reference:

Zeller T, et al. Latest results with new technologies for femoropopliteal obstructions: Drug-eluting devices, atherectomy and new implants. Presented at: Leipzig Interventional Course; Jan. 30-Feb. 2, 2018; Leipzig, Germany.

Disclosure: The study was funded by Spectranetics. Zeller reports he has consulted for Bard, Biotronik, Boston Scientific, Medtronic, Spectranetics and Trireme.