Drug-Coated Balloons in Critical Ischemia: The Paradigm of Randomized Evidence vs. Logbooks

This research, which included thousands of patients treated for chronic inferior limb ischemia with drug-coated balloons, did not show an association between said devices and the increased mortality observed in some randomized trials. 

Balones farmacológicos en isquemia crítica

The long-term evidence from plenty of real-world patients contradicts what has been shown in randomized trials, leaving an information gap.

Endovascular revascularization is the standard of care for infrapopliteal artery lesions, and paclitaxel-eluting balloons are widely used in said context.

Several randomized studies and meta-analysis have shown a mortality increase when using drug-coated balloons vs. conventional balloons in femoropopliteal lesions. This work registered long-term information in infrapopliteal disease.

Researchers included all patients who had undergone infrapopliteal angioplasty due to chronic inferior limb ischemia (intermittent claudication) between 2010 and 2018.

Read also: IN.PACT AV ACCESS | Drug-Coated Balloons for Dialysis Fistulas.

Only patients who had received their first and only treatment with drug-coated balloons were considered for the propensity score comparison with those who had received conventional balloons.

There were 14,738 patients (mean age 77.6 years) and 6568 matched patients included in the study to compare drug-coated vs. conventional balloons.

During the inclusion phase, there was an increase in the use of drug-coated balloon (from 6% in 2010 to 31% en 2018, p < 0.001). A total of 2611 deaths (39.8%) occurred within five years of follow-up.

Read also: How to Determine Optimal Balloon Size in Below-the-Knee Angioplasty.

A propensity score comparison yielded a reduction of mortality at 5 years (hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.78-0.91), amputation or death (HR: 0.87; 95% CI: 0.81-0.94), and cardiovascular event or death (HR_ 0.86; 95% CI: 0.80-0.9) when using drug-coated balloons vs. conventional balloons.


In this propensity-score matched cohort, there were reductions in mortality, amputation, and cardiovascular event rates at five years after using paclitaxel-eluting balloons compared with conventional balloons in patients with intermittent claudication.

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Original Title: Long Term Outcomes After Revascularization Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis.

Reference: Franziska Heidemann et al. Eur J Vasc Endovasc Surg (2020) 60, 549e558 https://doi.org/10.1016/j.ejvs.2020.06.033.

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