January 13, 2020

German Analysis Shows Long-Term Survival With Paclitaxel-Coated Devices Used for Femoropopliteal Artery Revascularization

January 13, 2020—The rapid adoption of the use of paclitaxel-coated devices to treat patients with chronic limb-threatening ischemia (CLTI) has resulted in higher long-term survival, better amputation-free survival, and lower rates of major cardiovascular events, concluded investigators of a retrospective, propensity score-matched cohort analysis of German health insurance claims. Christian-Alexander Behrendt, MD, et al published the findings online ahead of print in European Journal of Vascular and Endovascular Surgery (EJVES).

The aim of this study was to determine the survival of patients after the use of paclitaxel-coated devices for treatment in the context of the findings from Konstantinos Katsanos, MD, et al published in December 2018 in Journal of the American Heart Association. In that systematic review and meta‐analysis of randomized controlled trials evaluating paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries, Katsanos et al concluded that there was an increased risk of death after application of these devices in this anatomy.

In the current study, Behrendt et al identified index femoropopliteal arterial interventions performed between January 1, 2010, and December 31, 2018, covered by Barmer Health Insurance, the second-largest insurance fund in Germany.

As summarized in EJVES, the investigators excluded patients with previous interventions that deployed a paclitaxel device to ensure first paclitaxel exposure. The study was composed of 37,914 patients (mean age, 73.3 years; 48.8% women).

The study cohort was first stratified into patients with CLTI and intermittent claudication (IC), then into balloons versus stents cohorts. Within each stratum, paclitaxel devices were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan-Meier method and Cox regression.

The investigators found that the annual proportion of paclitaxel use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both, P < .001).

In the CLTI cohort at 5 years, paclitaxel-coated balloons and stents versus uncoated devices were associated with:

  • Improved overall survival (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.77–0.9)
  • Improved amputation-free survival (HR, 0.85; 95% CI, 0.78–0.91)
  • Freedom from major cardiovascular events (HR, 0.82; 95% CI, 0.77–0.89)

In the IC cohort at 5 years, mortality was significantly lower after using paclitaxel-coated balloons (HR, 0.87; 95% CI, 0.76–0.99) or combined paclitaxel-coated balloons and paclitaxel-eluting stents (HR, 0.88; 95% CI, 0.8–0.98), reported the investigators in EJVES.

These findings support those from a study published online in October 2019 by Eva Freisinger, MD, et al in European Heart Journal. The investigators in that real-world analysis of 9.2 million patients included in the Barmer Health Insurance database concluded there was no evidence for increased mortality associated with paclitaxel-based drug-eluting devices during 11 years of use in endovascular revascularization of peripheral vessels.


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