At 4 years, the Stellarex paclitaxel drug-coated balloon (DCB) demonstrated favorable long-term safety and efficacy outcomes supporting its use in treating femoropopliteal lesions, according to study results presented Sunday at the TCT Connect virtual conference.
Previous studies have described the short-term safety of paclitaxel-coated balloons; however, long-term data are lacking. The ILLUMENATE (Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon) Global trial was a prospective, single-arm, multicenter study designed to evaluate the Stellarex DCB (Royal Philips).
Included were 371 patients with Rutherford Clinical Classification (RCC) of 2-4 being treated for superficial femoral artery (SFA) or popliteal artery lesions. The primary outcome of interest was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target lesion revisualization (CD-TLR) through 12 months. The primary efficacy outcome was primary patency at 12 months.
Andrew Holden, MD, of Auckland Hospital, New Zealand, presented the 4-year results from the ILLUMENATE Trial at TCT Connect on Sunday. Patients had a mean age of 68.2 years, and 73% were men. Of those included, 42.3% of patients had previous intervention of the lower limb. De novo lesions occurred in 94% of patients with a mean luminal area of 0.96 mm and 40.8% having severe disease. Procedural success was achieved in 97.6% of patients with a mean post-procedure stenosis was 24.7% with a minimal luminal diameter of 3.43mm.
The primary patency rate at 12 months was 81.4. The CD-TLR rate at 1 year was 6.2%. The majority of patients (90.3%) experienced improvements in their RCC (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline, according to previously published findings.
Patients were followed out to 5 years post-procedure.
At 4 years, the primary safety endpoint of device- or procedure-related death occurred in zero patients and CD-TLR occurred in 21.8% of patients. Major target limb amputation occurred in just three patients. All-cause mortality occurred in 8.1% (n=30) of patients at 4 years. In a subgroup analysis, there were no significant differences in these outcomes stratified by sex, lesion length or pre-existing diabetes.
Holden concluded that these data support durable long-term outcomes with the Stellarex DCB in de novo and re-stenotic in peripheral arterial disease irrespective of gender or diabetes.
The ILLUMENATE trial was sponsored by Philips Image Guided Therapy.