Similar patency outcomes in women and men treated with Stellarex DCB

Stellarex DCB

A study presented at VIVA 2018 (5–8 November, Las Vegas, USA) by Maureen Kohi, associate professor of Clinical Radiology, University of California, San Francisco, USA, has found similar patency outcomes in women and men after treatment with the Stellarex DCB and calls for further research in the area.

The purpose of the trial was to evaluate sex-related differences in the outcomes of the Stellarex drug-coated balloon (DCB, Philips) for the treatment of femoropopliteal arterial disease. A subgroup analysis of the DCB cohort of the Europe and US ILLUMENATE trial was performed. The study endpoints included primary safety and efficacy at 12 months and were compared between men and women. To identify predictive factors for patency, a multivariable predictor analysis was performed.

The study included a total of 418 patients with 269 men (64%) and 149 women (36%). The female subgroup was significantly older compared to men. The mean reference vessel diameter was significantly smaller and the lesion length was significantly longer in the female subgroup compared to the male subgroup.

There was no significant difference in the 12-month primary patency rate or clinically driven target lesion revascularisation rate between men and women. The multivariate analysis demonstrated that reference vessel diameter, lesion length, previous intervention in study limb, severe calcification, and geographic miss were predictors of patency.

Based on this study, despite older age, more comorbidities, and worse vessel and lesion characteristics, women had similar patency outcomes compared to men after treatment with the Stellarex DCB. As a result, Kohi said that further evaluation of the efficacy of DCBs is necessary to understand the disparate nature of the disease progression and to optimise treatment outcomes in women with peripheral arterial disease.


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