The use of paclitaxel drug-coated balloon (DCB) angioplasty for femoropopliteal lesions was associated with reduced  long-term mortality compared with uncoated balloon angioplasty (POBA), according to results published in JACC: Cardiovascular. Interventions.1

Results from a meta-analysis of randomized controlled trials indicated that the use of paclitaxel-coated devices may increase the risk for long-term mortality after femoropopliteal angioplasty.2

The primary endpoint of the study was the difference in all-cause mortality between groups. Secondary endpoints included 3- and 5-year mortality rates, as well as the relationship between the concentration and mortality in patients who had received DCB angioplasty.


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Of the 1579 patients included in the analysis, 514 patients (66.7% men) were treated using POBA, and 1065 (63.8% men) with DCB angioplasty. Over the course of follow-up (mean, 52.0 months), 323 patients (20.5%) died.

The incidence of all-cause mortality was significantly higher in the POBA group (27.8%) compared with the DCB group (16.9%; P <.001). The 3- and 5-year mortality rates were also significantly higher in the POBA vs DCB group (P <.001 for both). Similar results were observed in matched pair analyses and when octogenarians were excluded.

POBA treatment was found to be an independent predictor of all-cause mortality in a multivariate analysis (P =.009). There was no correlation between drug concentration used in DCB and mortality.

The investigators noted that the cause of death could not be determined for almost half of the study population.

“In this real world study, treatment of femoropopliteal lesions with DCB…resulted in a survival advantage,” the study authors concluded. “All-comers randomized clinical trials are necessary to proof this long-term survival benefit and to identify the potential causation such as a mobility benefit resulting in a positive risk profile modification as a result of a patent vessel.”

Disclosures: Dr Noory and Dr Zeller reported. Affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.

References

  1. Böhme T, Noory E, Beschorner U, et al. Evaluation of mortality following paclitaxel drug coated balloon angioplasty of femoropopliteal lesions in the real world [published online June 18, 2020]. JACC Cardiovasc Interv. doi:10.1016/j.jcin.2020.04.050
  2. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018;7(24):e011245. doi:10.1161/JAHA.118.011245