ILLUMENATE Global: DCB safe, effective in real-world cohort at 4 years
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A low-dose paclitaxel-coated balloon was safe and effective at 4 years in real-world patients with peripheral artery disease, according to the ILLUMENATE Global results presented at the virtual TCT Connect.
The results of the prospective, single-arm study were comparable to those seen in patients treated with the paclitaxel-coated balloon (Stellarex, Philips) in randomized trials, which typically have a lower-risk population than real-world registries, Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, director of interventional radiology at Auckland Hospital in New Zealand, said during a presentation.
ILLUMENTATE Global was “a rigorous study on an expanded population” that “shows favorable safety and efficacy consistent with the randomized controlled trials,” he said.
Among 371 patients (mean age, 68 years; 73% men) with 417 lesions (31.3% total occlusions; 40.8% with severe calcification) in the superficial femoral or popliteal arteries, 75.6% were free from clinically driven target lesion revascularization at 4 years according to the Kaplan-Meier estimate (raw percentage, 77.9%), Holden said during the presentation.
In addition, 8.1% had died and 0.8% had undergone major target limb amputation, he said.
“With all these discussions about paclitaxel-related safety concerns, in this study at 4 years, there was, in my opinion, a low all-cause mortality rate of 8.1%,” study investigator Marianne Brodmann, MD, substitute head of the division of angiology at Medical University Graz, Austria, said during a press conference. “There were some patients with Rutherford category 4 and 5, and critical limb ischemia patients usually have a higher risk of mortality.”
There was no difference in freedom from clinically driven TLR within prespecified subgroups, including sex (P for interaction = .263), lesion length 15 cm or more vs. less than 15 cm (P for interaction = .143) and diabetes status (P for interaction = .752), according to the researchers.
“We know that females usually do worse with regard to long-term outcomes with endovascular revascularization, but there was no difference,” Brodmann said at the press conference.
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Holden A, et al. Endovascular 1: Late-breaking clinical trials and science. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
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