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PCB for below-the-knee lesions does not confer long-term safety concern

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A paclitaxel-coated balloon for treatment of below-the-knee lesions was not associated with excess mortality or amputation risk at 3 years, researchers reported at the Leipzig Interventional Course.

As Healio previously reported, a recent meta-analysis of randomized controlled trials of treatment of infrapopliteal arteries found that paclitaxel-coated balloons conferred worse amputation-free survival compared with uncoated balloons at 1 year.

However, there was no such signal at 3 years in the Lutonix BTK study of a PCB (Lutonix 014, BD), Patrick J. Geraghty, MD, FACS, professor of surgery and radiology at Washington University School of Medicine in St. Louis, said during a presentation.

In 3-year data from 294 patients from the trial, freedom from all-cause death was 81% in both those assigned the PCB and those assigned percutaneous transluminal angioplasty (HR = 1.04; 95% CI, 0.63-1.71); freedom from major amputation was 95.5% in the PCB group and 93.8% in the PTA group (HR = 0.81; 95% CI, 0.32-2.1); and amputation-free survival was 77.8% in both groups (HR = 1.04; 95% CI, 0.66-1.64), Geraghty said.

Geraghty also presented 1-year efficacy results. Healio previously reported that at 6 months, the PCB conferred superior efficacy and similar safety compared with standard balloon angioplasty for treatment of narrowed or obstructed arteries below the knee.

At 1 year, the efficacy data no longer favored the PCB, he said. The efficacy endpoint of freedom from major amputation, target vessel occlusion and clinically driven target lesion revascularization was 60.3% in the PCB group and 60.9% in the PTA group (difference, –0.6%; P = .54).

The groups were also similar at 1 year in freedom from clinically driven TLR (PCB, 80.3%; PTA, 79.4%; difference, 0.9%; P = .42), he said.

“The cumulative TLR rate, which was more than two times greater in the PTA group than in the DCB group at 6 months, converged but still numerically favored the DCB group at 12 months,” Geraghty said during the presentation. “Additionally, the improvement in toe-brachial index through 12 months was similar between groups.” – by Erik Swain

Reference:

Geraghty P, et al. Optimizing the treatment of BTK vessels in critical limb ischemia. Presented at: Leipzig Interventional Course; Jan. 28-31, 2020; Leipzig, Germany.

Disclosure: The study was funded by Bard Peripheral Vascular, now part of BD. Geraghty reports he consults for BD/Bard Peripheral Vascular and Boston Scientific and holds equity in Euphrates Vascular.