3.2 / IAGS 2019
Session 3: Endovascular Session 1
Should the Vascular Use of Paclitaxel be Banned?
Problem Presenter: Doug Cavaye, MD
Statement of the problem
A recent meta-analysis of randomized controlled trials (RCT) suggests a possible increased mortality rate after two years in patients treated for atherosclerosis of the femoro-popliteal arteries using paclitaxel-coated balloons and paclitaxel-eluting stents, compared to patients treated with control devices (non-coated balloons or bare metal stents). The specific cause for this observation has not been identified (Katsanos K, et al; JAHA 118 01 1245).
Gaps in knowledge
Of the 28 RCTs analyzed (4663 patients), there were only 3 trials with 5-year follow-up data (863 patients). Each RCT showed higher mortality in patients treated with paclitaxel-coated devices than those treated with uncoated devices (20.1% versus 13.4% for crude risk of death at 5 years). It was noted that there was marked heterogeneity across the trials, and accurate mortality risk estimation was potentially low-powered, as a result of the small amount of longer-term data. Because the 28 original trials were not specifically designed for data pooling and meta-analysis, the value and reliability of the conclusions becomes uncertain. There was also no specific cause for the increased mortality identified in the study conclusions. It was also noted that paclitaxel has been used as an intravenous chemotherapy agent for many years, using vastly higher doses than those in the drug-eluting intravascular devices, without any specific unexpected drug-related mortality reported.
Possible solutions & future directions
Because there is significant and proven benefit from paclitaxel-coated balloons and stents with regard to patency and restenosis reduction, it was determined that these devices should continue to be used. Discussion of risks and benefits in individual patients is paramount, and should continue to guide treatment options for femoro-popliteal atherosclerosis. It was noted that the FDA has issued correspondence on two occasions, January 17 2019 and March 15 2019, and provides specific guidelines for device vigilance and disclosure.