Mortality after Paclitaxel-Coated Device Use in Patients with Lower Limb Ischemia: An Updated Systematic Review and Meta-Analysis.
Presenter
Kameel Kassab, MD, FSCAI, Cook County Health, Chicago, IL
Kameel Kassab, MD, FSCAI, Saurabh Malhotra, MD, MPH, FASNC and Aviral Vij, M.D, MSc, FSCAI, Cook County Health, Chicago, IL
Keywords: Critical Limb Ischemia/Chronic Limb-threatening Ischemia (CLT/CLTI), Peripheral Artery Disease (PAD) and Peripheral Vascular Disease (PVD)
Background:
Paclitaxel coated balloon or eluting device use in peripheral arterial disease (PAD) has become increasingly controversial with several meta-analyses reporting increased mortality with use. FDA issued an update in August 2019 recommending a risk/benefit discussion with patients prior to these devices. We sought to perform an updated meta-analysis comparing outcomes in patients with paclitaxel device use to those with no-eluting device.
Methods:
Randomized controlled trials incorporating individual patient level data from eight studies as published by Rocha-Singh et al and the recently published largest patient study to date by Nordanstig et al were included in our analysis. Primary outcome was all-cause mortality. We analyzed a total of 4430 patients with 476 events in the Paclitaxel group and 361 events in the non-eluting group. Pooled risk ratio (RR) with 95% confidence intervals (CI) using random-effects model was performed.
Results:
There is no statistically significant difference in primary outcome of all-cause mortality between the two treatment arms. Summary effect size (RR) of 1.20 [CI = 0.95 to 1.52, p = 0.13] (Figure 1).
Conclusions:
This analysis did not show an increase in mortality with use of paclitaxel coated device in patients with PAD. Our results add to the available evidence on safety of paclitaxel and contradicts the results of previous meta-analyses which have significant heterogeneity, small number of patients and possibly inflated effect sizes. 