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Friday, March 6, 2020

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A systematic Review and Meta-Analysis of Randomized Controlled Trials

Clinical question
Does the use of drug coated balloons in infrapopliteal peripheral arterial disease during revascularization in patient’s with critical limb ischemia lead to an increased risk of death or amputation

Take-away point
Analysis of 8 randomized control trials demonstrated worse amputation-free survival with use of paclitaxel coated balloons

Konstantinos Katsanos et al. Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Journal of Vascular and Interventional Radiology. Feb, 2020: 31; 2.

Click for abstract

Study design

Funding source
Self-funded or unfunded


Figure 3. (a) All-cause death and (b) major amputations. A generalized linear mixed (GLM) effects model was employed for sparse data. The summary effect was expressed as OR.


Placlitaxel-coated balloons (PCBs) gained quick popularity due to multiple studies demonstrating reduced vessel restenosis and decreased target lesion revascularization compared to plain old balloon angioplasty for femoropopliteal disease in claudicants. Recent publications have demonstrated increased patient all-cause mortality at 2 and 5 years with PCBs. This present study performed a similar systematic review and meta-analysis of PCB use in the infrapopliteal segment for patients with critical limb ischemia. Ultimately, 8 studies were identified and included in their analysis. The studies demonstrated a significant reduction in target lesion revascularization. However, the studies homogeneously demonstrated that amputation free survival was significantly lower following treatment with PCBs (number needed to harm of 22 patients). This was demonstrated by both higher rates of amputations and death. Additionally, amputation free survival was worse with higher dose PCBs.


This paper dovetails with the major 2018 publication demonstrating increased all-cause mortality with use of PCBs in claudicants with femoropopliteal disease which has since been confirmed by the FDA. This study similarly demonstrates adverse effects, specifically death and amputation, from use of PCBs, however now within the infrapopliteal critical limb ischemia population. This study has limitations, most notably that the meta-analysis does not allow individual patient level analysis and the relatively short follow up time of 1 year. While we still do not have a cause of these adverse outcomes, this further builds evidence to caution our use of PCBs, a marked change after these devices had quickly ascended to be used as near standard of care.

Post author:
David M Mauro, MD
Assistant Professor
Department of Radiology, Vascular and Interventional Radiology
University of North Carolina


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