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Mortality After Use of Paclitaxel-Based Devices in Peripheral Arteries
Study Questions:
Is there an increase in mortality after use of paclitaxel-based drug-eluting devices (DED) in peripheral arteries?
Methods:
The investigators conducted a cohort study using the anonymized insurance claims of approximately 9.2 million patients in the German BARMER Health Insurance. Data from these patients on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved since their introduction on the market in 2007 until present. All patients with first endovascular revascularization (EVR) between 2007 and 2015 were indexed and followed until December 31, 2017. Each subsequently applied DES, DCB, bare-metal stent, and uncoated balloon was included in further analyses. Multivariable Cox regression analysis considered potential nonlinear time-dependent hazard ratios (HRs) of DES and DCB over 11 years.
Results:
A total of 64,771 patients were identified, who underwent 107,112 EVR procedures using 23,137 DED. Multivariable Cox regression analysis showed paclitaxel-based DES not to be associated with increased long-term mortality for over 11 years past application (all p > 0.057). DCB was associated with decreased long-term mortality for the first year past application (HR, 0.92; p < 0.001), and indifferent correlation in the years thereafter (all p > 0.202).
Conclusions:
The authors concluded that real-world analysis showed no evidence for increased mortality associated with paclitaxel-based DED for over 11 years.
Perspective:
This health claims-based cohort study reports that the use of paclitaxel-based DED was not associated with exceeding death rates compared to non-DED. Limitations of the study include use of secondary health care data with potential selection bias, lack of data on individual paclitaxel load, and methodological simplification using time-dependent Cox regression analysis cumulated devices of each type within annual time intervals. The August 7, 2019 Food and Drug Administration (FDA) recommendations provide excellent guidance for clinicians and state that physicians should discuss the risks and benefits of all available peripheral artery disease treatment options with patients, and for many patients, alternative treatment options to paclitaxel-coated devices provide a more favorable benefit-risk profile based on currently available information. Paclitaxel-eluting stents or balloons should continue to be used where benefits outweigh the risks. Given contradictory data, additional prospective studies are indicated to assess potential mortality risk with paclitaxel-eluting devices.
Keywords: Cardiology Interventions, Drug-Eluting Stents, Endovascular Procedures, Myocardial Revascularization, Paclitaxel, Peripheral Arterial Disease, Risk Assessment, Secondary Prevention, Stents, Vascular Diseases
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