One-Year Results Published From ILLUMENATE EU RCT for Spectranetics' Stellarex DCB

May 5, 2017—The 1-year results of the ILLUMENATE European randomized clinical trial (EU RCT) were published by Henrik Schroeder, MD, et al online ahead of print in Circulation.

In August 2016, Spectranetics Corporation announced that these results evaluating the company's Stellarex drug-coated balloon (DCB) were presented at AMP: the Amputation Prevention Symposium in Chicago, Illinois. The Stellarex DCB is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral artery disease (PAD).

As explained by the investigators in Circulation, numerous studies have reported favorable outcomes using DCBs for the treatment of symptomatic PAD of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2 µg/mm² surface dose of paclitaxel) DCB.

In this prospective, randomized, multicenter, single-blinded trial, patients were randomized (3:1) to treatment with the low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months postprocedure. The primary effectiveness endpoint was primary patency at 12 months.

After successful predilatation, 222 patients (254 lesions) were randomized to treatment with a DCB and 72 patients (79 lesions) were randomized to uncoated PTA balloon treatment. In the DCB group versus the PTA group, mean lesion length was 7.2 cm and 7.1 cm; 19.2% and 19% of lesions represented total occlusions, respectively.

The ILLUMENATE EU RCT investigators reported that the primary safety endpoint was met and superiority was demonstrated; freedom from a primary safety event was 94.1% (193/205) with DCB and 83.3% (50/60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%–23.0%). The primary effectiveness endpoint was met and superiority of DCB over PTA was achieved (83.9% [188/224] vs 60.6% [40/66]; P < .001). Outcomes with the DCB were also superior to PTA per Kaplan-Meier estimate for primary patency (89% vs 65% at 365 days; log-rank P < .001) and for rates of clinically driven target lesion revascularization (5.9% vs 16.7%; P = .014).

Superiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness endpoints, concluded the investigators in Circulation.