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August 24, 2020

Analysis of German Insurance Claims Shows Improved Long-Term Outcomes With Paclitaxel-Coated Devices in BTK Revascularization

August 24, 2020—Christian-Alexander Behrendt, MD, announced the publication of a study on long-term outcomes with paclitaxel-coated devices used to treat chronic limb-threatening ischemia (CLTI) in below-the-knee (BTK) arteries.

The investigators evaluated treatment with the devices in routine vascular care in a large and contemporary cohort, using data from health insurance claims covered by Barmer Health Insurance, the second-largest insurance fund in Germany. The study by Franziska Heidemann, MD, et al is available online ahead of print in European Journal of Vascular and Endovascular Surgery (EJVES).

Dr. Behrendt advised that the results will be presented at the European Society for Vascular Surgery’s (ESVS) annual meeting, which will be held virtually as ESVS Month on Tuesdays and Thursdays from September 29 to October 22, 2020. The study will also be presented at the VEITHsymposium, now scheduled for February 23-27, 2021 in New York, New York.

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.

Earlier this year, in an analysis of femoropopliteal artery revascularization, Dr. Behrendt et al reported findings from a similar retrospective, propensity score–matched cohort analysis of the Barmer health insurance claims. The investigators found then that paclitaxel-coated devices to treat patients with CLTI resulted in higher long-term survival, better amputation-free survival, and lower rates of major cardiovascular events. That study is available in print in the April issue of the EJVES (2020; 59: 587-596).

In communication with Endovascular Today, Dr. Behrendt commented, “In line with the first study from our group, we found no evidence for a safety signal. After dissecting this interesting research topic and the available data for more than 18 months, we are confident that there is no safety signal in real-world evidence from Germany. In the end, this may serve as a proper role model for other health issues. While sufficiently powered randomized controlled trials are needed to prove causalities, unselected real-world data are the first choice for valid quality assurance.”

In the EJVES abstract of the BTK study, the investigators concluded, “The propensity score–matched cohort demonstrated reduced long-term all-cause mortality, reduced rates of amputation or death and cardiovascular event or death at 5 years after the use of paclitaxel-coated devices when compared with uncoated devices to treat CLTI.”

As summarized in EJVES, the retrospective cohort study was composed of 14,738 patients (mean age 77.6 years; 43.6% women) and 6,568 propensity score–matched patients with index BTK revascularization performed between January 1, 2010 and December 31, 2018. Only patients with first paclitaxel-coated device exposure were included. The cohort was stratified into balloon versus stent treatment. Patients with paclitaxel-coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan Meier method and Cox regression.

The investigators observed the following:

  • Increased use of paclitaxel-coated devices during the study period (6% in 2010 vs 31% in 2018; P < .001)
  • A total of 2,611 (39.8%) deaths within 5 years of follow-up
  • A paclitaxel-related reduction of 5-year mortality (hazards ratio [HR], 0.84; 95% 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 0.80-0.92) in the propensity score-matched Cox model

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