After two years of follow-up, the ILLUMENATE Global study has confirmed the durability of the Stellarex drug-coated balloon (Spectranetics/Philips) with primary patency rates comparable to those reported in randomised controlled trials.
The data were presented by principal investigator Thomas Zeller (Bad Krozingen, Germany) at the Leipzig Interventional Course (LINC; 30 January–2 February 2018, Leipzig, Germany).
The ILLUMENTATE Global study is a prospective, multicentre, single arm study using the Stellarex low dose paclitaxel-coated balloon. The primary objective is to assess safety and performance of the device in the superficial femoral artery (SFA) and/or the popliteal arteries. The primary safety endpoint is freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target lesion revascularisation through 12 months. The primary effectiveness endpoint is one year primary patency. Patients will be followed out to five years.
Of the 371 patients enrolled, the majority included in the trial had a baseline Rutherford class of 3. Total occlusions have been present in one third of lesions (31.3%, 129/412) and severe calcification (both sides of the arterial wall and extending more than 1cm in length prior to contrast injection or digital selection) in 40.8% (169/402).
Zeller reported that there was a freedom from primary safety event of 85.3% at two years, with no device or procedure-related death and one major target limb amputation. Further, all-cause mortality through 24 months was 2.7% (9/337) and the clinically-driven target lesion revascularisation rate was 17.8% (59/331).
In terms of the primary effectiveness endpoint, Zeller noted that at two years, the primary patency was 72.4%. As to how this rate compares to that in randomised controlled studies of drug-coated balloons, he said that the Kaplan Meier estimate is very similar to the ILLUMENATE EU randomised controlled trial at two years, slightly inferior to the IN.PACT SFA randomised controlled trial and superior to the LEVANT 2 trial outcome data.
As for key secondary outcomes, Zeller reported that 86.9% of patients assessed at baseline and at two years had an improvement in their Rutherford classification overtime.
“If you look at freedom from claudication overtime it is a stable course—two thirds of the patients remained without any symptoms at two years,” he said.
Additionally, 78.4% of patients had an improvement in their walking impairment questionnaire score at two years compared to baseline.
Zeller concluded that the ILLUMENATE Global study—one of the largest drug-coated balloon cohorts with independent core-lab and clinical event committee adjudication—has demonstrated the durable performance of the Stellarex drug-coated balloon at two years with a 72.4% primary patency rate and 85.3% freedom from clinically-driven target lesion revascularisation.
“The two-year results from the ILLUMENATE Global study confirm that a low-dose next generation drug-coated balloon can deliver sustained patency,” he added.