ILLUMENATE: DCB superior to PTA for treatment of PAD in upper leg

CHICAGO — A drug-coated balloon was superior in safety and efficacy vs. percutaneous transluminal angioplasty in patients with peripheral artery disease in the superficial femoral and popliteal arteries, according to final 1-year results of the ILLUMENATE European Randomized Clinical Trial.

The findings are consistent with results from the ILLUMENATE First-in-Human study and the ILLUMENATE Global registry, Marianne Brodmann, MD, said during a presentation at AMP: The Amputation Prevention Symposium.

Marianne Brodmann

Brodmann, substitute head of the clinical division of angiology, department of internal medicine, Medical University Graz, Austria, and colleagues randomly assigned on a 3:1 basis 295 patients with lesions in the superficial femoral or popliteal arteries and Rutherford class 2, 3 or 4 to treatment with the DCB (Stellarex, Spectranetics) or percutaneous transluminal angioplasty (PTA; DCB group: mean age, 67 years; 72% men; PTA group: mean age, 68 years; 68% men). Patients with severe calcification unlikely to be treated effectively with PTA were excluded.

The DCB is not yet approved for use in the United States.

The primary safety endpoint was freedom from death related to the device or procedure at 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization at 12 months. The primary efficacy endpoint was 12-month primary patency, defined as freedom from restenosis and freedom from clinically driven TLR.

The primary safety endpoint met superiority criteria (DCB, 94.1%; 95% CI, 90-96.9; PTA, 83.3%; 95% CI, 71.6-91.7; difference, 10.8%; 95% CI, 0.9-23), Brodmann said.

Primary patency at 12 months was 89% in the DCB group vs. 65% in the PTA group (log-rank P < .001), whereas freedom from clinically driven TLR at 12 months was 94.8% in the DCB group vs. 85.3% in the PTA group (log-rank P = .01), she said.

At 12 months, the rate of reintervention was nearly three times greater in the PTA group than in the DCB group, according to Brodmann.

“The Stellarex DCB has demonstrated consistently positive results in primary patency and clinically driven TLR,” she said, noting that results from the ILLUMENATE Pivotal trial of patients in the United States will be presented in fall 2016. – by Erik Swain

Reference:

Brodmann M, et al. SFA and popliteal artery treatment options in 2016: Where do we stand and what should we do? Presented at: AMP: The Amputation Prevention Symposium; Aug. 10-13, 2016; Chicago.

Disclosure: The study was funded by Spectranetics. Brodmann reports receiving grant/research support from Biotronik; consulting for or serving as an adviser to Avinger, Corindus, Intact Vascular and Medtronic; and speaking for Avinger, Corindus, Covidien, Intact Vascular and Medtronic.