Study Explores Impact of Patient Sex on Outcomes in Stellarex Drug-Coated Balloon PAD Treatment


November 6, 2018—Data from a subgroup analysis of the Stellarex drug-coated balloon (DCB, Philips) cohort from the ILLUMENATE trial demonstrated that DCB treatment of femoropopliteal artery disease yielded similar patency outcomes in women and men. The findings were presented by Maureen P. Kohi, MD, FSIR, at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada. Dr. Kohi is Associate Professor of Clinical Radiology and Chief of Interventional Radiology at University of California San Francisco.

Of the 418 patients enrolled, 149 of whom were women (36%). Dr. Kohi noted that although this proportion of women is relatively high compared to most peripheral interventional studies, it is likely quite low compared to the actual incidence of peripheral artery disease, which may equal or even exceed that of men.

The female subgroup was noted to be 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. However, there was no observed significant difference in either primary patency or clinically driven target lesions revascularization rates between the two groups.

Multivariate analysis demonstrated that reference vessel diameter, lesion length, previous intervention of study limb, sever calcification, and geographic miss were predictors of patency. Of note, low population numbers (due to subset analysis) confound statistical significance of multivariate analyses.

Although the outcomes of DCB treatment in women enrolled in ILLUMENATE are encouraging, further evaluation of the disparate disease nature of disease progression in women is needed, as are efforts toward finding women with PAD earlier in their lives and working toward better representation in clinical trials, concluded Dr. Kohi.


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