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ILLUMENATE: DCB effective at 4 years with no mortality hazard

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Sean Lyden

A paclitaxel-coated balloon was safe and effective in patients with peripheral artery disease at 4 years and did not confer elevated mortality risk compared with percutaneous transluminal angioplasty, according to new data from the ILLUMENATE Pivotal trial.

The trial included 300 patients with PAD (mean age, 69 years; 41% women) assigned the DCB (Stellarex, Philips) or PTA.

All-cause mortality at 4 years did not differ between the groups (DCB, 15.6%; PTA, 15.2%; P = .929), Sean Lyden, MD, chairman of the department of vascular surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute and chief medical officer of Excelerate Strategic Health Sourcing, said during a presentation at Leipzig Interventional Course. As Healio previously reported, concern has arisen about long-term mortality signals associated with paclitaxel-coated devices for treatment of PAD.

He noted the survival curves overlapped over 4 years (log-rank P = .742), which was also the case in the 3-year data from the study.

Lyden said there were also no significant differences between the groups at 4 years in the following outcomes:

• CV mortality (DCB, 5.6%; PTA, 8.3%; P = .409);
• the composite safety endpoint of freedom from device and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization at 4 years (DCB, 71.2%; PTA, 65.9%; P = .399);
• target major limb amputation (DCB, 0.7%; PTA, 0%; P = 1); and
• clinically driven TLR (DCB, 28.2%; PTA, 34.1%; P = .343).

Primary patency at 3 years, defined as freedom from target lesion restenosis and clinically driven TLR, was 64.2% in the DCB group and 51% in the PTA group (P = .016), he said.

“The Stellarex DCB continues to show a high safety profile with sustained treatment effect through 4 years,” Lyden said during the presentation. “The 4-year data demonstrate a clinically relevant difference, with a lower clinically driven TLR rate in the Stellarex DCB group compared with PTA. Stellarex is the only low-dose DCB supported by head-to-head 4-year randomized data with favorable safety and efficacy within an extensive complex patient cohort.” – by Erik Swain

Reference:

Lyden S, et al. Latest insights on safety and efficacy of drug-coated devices. Presented at: Leipzig Interventional Course; Jan. 28-31, 2020; Leipzig, Germany.

Disclosure: The study was funded by Philips. Lyden reports he consults for Philips but received no compensation for the analysis and presentation of the study.