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ILLUMENATE Global: DCB safe, effective in complex peripheral lesions at 12 months

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A drug-coated balloon effectively treated complex lesions in the superficial femoral and popliteal arteries, according to the final 12-month results of the ILLUMENATE Global study.

The DCB (Stellarex, Spectranetics) was evaluated in 371 patients (mean age, 68 years; 73% men) with Rutherford class 2, 3 or 4 superficial femoral or popliteal lesions, of whom 31% had chronic total occlusions and 40.8% had severe calcification. The results were presented at the Leipzig Interventional Course by Thomas Zeller, MD, PhD, head physician in the department of angiology at Universitäts Herzzentrum, Bad Krozingen, Germany.

“In a real-world setting, ILLUMENATE Global validates the earlier ILLUMENATE US Pivotal results, achieving best-in-class 12-month primary patency rates in a patient cohort with the highest rate of severe calcium yet studied,” Zeller said in a press release. “These results are significant because severe calcium has been one of the greatest challenges in our DCB practice.”

Thomas Zeller

The primary safety endpoint was freedom from device and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization at 12 months. The primary effectiveness endpoint was 12-month primary patency, defined as peak systolic velocity ratio 2.5 and no clinically driven TLR.

The primary safety endpoint occurred in 20 patients — one who had major target limb amputation and 19 who had clinically driven TLR — for a rate of freedom from the primary safety endpoint of 94.8%, according to Zeller.

All-cause mortality at 12 months was 0.6%, as two patients died from cancer, Zeller said.

The rate of freedom from clinically driven TLR at 12 months was 94.8% and the rate of primary patency at 12 months was 81.4%, according to Zeller.

The 12-month primary patency results were similar to that of the ILLUMENATE US Pivotal, which was 82.3% in a cohort of 43.9% of patients with severely calcified lesions, and comparable to that of three other cohorts with less than 13% of patients with severely calcified lesions, he said.

Rutherford class improved from baseline to 12 months in 90.3% of patients (P < .001), and Walking Impairment Questionnaire score improved from baseline to 12 months in 83.6% (P < .001), according to Zeller.

The findings confirm that “a low-dose next-generation DCB can outperform within a wide range of patient complexities,” Zeller said during the presentation.

The DCB is not yet approved for use in the United States. – by Erik Swain

Reference:

Zeller T, et al. Drug-eluting devices for prevention of restenosis — the new standard for femoropopliteal interventions in claudicants. Presented at: Leipzig Interventional Course; Jan. 24-27, 2017; Leipzig, Germany.

Disclosure: The study was funded by Spectranetics. Zeller reports consulting for Bard, Biotronik, Boston Scientific, Medtronic, Spectranetics and Trireme.