Stellarex DCB shows promise for treatment of femoropopliteal disease

LAS VEGAS — New data from the ILLUMENATE FIH study suggest that a drug-coated balloon for the treatment of peripheral artery disease was effective without predilatation in patients with noncomplex disease.

“Most studies assessing the effectiveness of drug-coated balloons (DCB) for the treatment of PAD have required predilatation of the target lesion with an uncoated angioplasty balloon prior to use of the DCB. The necessity or additional benefit of predilatation of a target lesion with an uncoated angioplasty catheter prior to use of a DCB is unknown,” according to an abstract.

The prospective, multicenter ILLUMENATE FIH study was designed to assess the safety and efficacy of the DCB (Stellarex, Spectranetics) for treatment of femoropopliteal disease. The study enrolled two cohorts: the first 50 patients were treated with predilatation with an uncoated angioplasty balloon before inflation of the DCB (predilatation cohort) and the subsequent 30 patients who received DCB only (direct cohort). Twelve- and 24-month results of the predilatation cohort were previously published.

During a late-breaking clinical trials session at VIVA 15, Prakash Krishnan, MD, of Mount Sinai Medical Center, presented 12- and 24-month outcomes from the direct cohort (n = 28; two patients excluded from analysis).

The direct cohort had a mean age of 66 years, 29% were women, 68% reported smoking, 86% presented with hypertension, 79% presented with hyperlipidemia and 54% presented with diabetes. Mean lesion length was 63.9 mm; nearly half of lesions were calcified.

According to Krishnan, the direct cohort exhibited similar outcomes as those in the predilatation cohort. The direct cohort more frequently required postdilatation (35.1% vs. 12.1%; P = .01) and use of stents (8.1% vs. 5.2%; P = .67) compared with the predilatation cohort. Late lumen loss at 6 months was 0.03 mm in the direct cohort, which Krishnan said demonstrates a good drug effect of the DCB in the absence of predilatation. Primary patency at 12 months was 86.2%, compared with 89.5% in the predilatation cohort, and at 24 months was 78.2%, compared with 80.3% in the predilatation cohort. Freedom from target lesion revascularization within the direct cohort was 85.4% at 12 months and 81.7% at 24 months, compared with 90% and 85.8%, respectively, in the predilatation cohort.

The researchers observed sustained improvements in functional outcomes including walking score and ankle-brachial index through 24 months in both cohorts.

“The direct cohort findings support durable outcomes observed in the predilatation cohort,” Krishnan concluded. However, “the question of predilatation remains to be answered. But [in this study] predilatation looks to have the potential to reduce need for provisional stenting in very small numbers. … I think we need a robust cadence of clinical studies, and we are starting to get that.” – by Jason Laday

Reference:

Krishnan P, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.

Disclosure: Krishnan reports consulting for Abbott Vascular and Covidien.