JACC Patient-Level Analysis of Medtronic DCB Studies Concludes That Mortality Is Not Correlated With Paclitaxel Exposure


January 31, 2019—Peter A. Schneider, MD, et al conducted a patient-level analysis of data from several independently adjudicated prospective studies involving Medtronic drug-coated balloons (DCBs). The findings were published online ahead of print in Journal of the American College of Cardiology (JACC).

This study was conducted in response to recently published findings from a systematic review and meta‐analysis of heterogeneous randomized controlled trials evaluating the use of various paclitaxel‐coated/eluting balloons and stents in the femoral and/or popliteal arteries. Conducted by Konstantinos Katsanos, MD, et al and published in Journal of the American Heart Association, the meta-analysis concluded that there is an increased long-term risk of death associated with these applications, and also that higher doses are linked to higher mortality within 2 to 5 years.

However, in the JACC publication, the investigators found that through 5 years, there was no statistically significant difference in all-cause mortality between DCB and percutaneous transluminal angioplasty (PTA), while survival analyses stratifying paclitaxel dose found no statistically significant difference in all-cause mortality.

As previously reported in Endovascular Today, patient-level analyses from this and other major DCB and drug-eluting stent programs were presented at LINC, the Leipzig Interventional Course, which was held January 22–25, 2019, in Leipzig, Germany. 

The investigators reported on the performance of extensive analyses of baseline, procedure, and follow-up data of individual patients to explore correlations with long-term mortality. Time to survival by paclitaxel dose was analyzed in terciles, with adjustments to correct for any baseline imbalances. 

As summarized in JACC, specific findings included:

  • No statistically significant difference in all-cause mortality between DCB and PTA through 5 years (9.3% vs 11.2%; P = .399).
  • No deaths were determined to be device related, as adjudicated by an independent clinical events committee.
  • In the survival analysis that stratified nominal paclitaxel dose by low (mean, 5,019.0 μg), mid (mean, 10,007.5 μg), and upper (mean,19,978.2 μg) terciles, there was no statistically significant difference in all-cause mortality between the three groups through 5 years (P = .700).

According to the Dr. Schneider and colleagues, the data from 5 years of prospective clinical trials confirm that treatment with a paclitaxel DCB is safe and effective to treat femoropopliteal artery disease, and this independent patient-level meta-analysis demonstrates that paclitaxel DCBs are safe and there is no correlation between any level of paclitaxel exposure and mortality. 

The investigators included Dr. Schneider; John R. Laird Jr, MD; Gheorghe Doros, PhD; Qi Gao, MS; Gary Ansel, MD; Marianne Brodmann, MD; Antonio Micari, MD; Mehdi H. Shishehbor, DO; Gunnar Tepe, MD; and Thomas Zeller, MD. The analysis was funded by Medtronic, with data independently analyzed by the Baim Institute for Clinical Research. 


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