Purpose: Since the paclitaxel conundrum set forth in 2018 by Katsanos et al, the safety profile of DET has been under scrutiny with concerns of increased mortality, despite higher rates of freedom from target lesion revascularization. As a dedicated limb salvage center treating Rutherford classification (RC) 3-6 patients, we performed a retrospective analysis of our single center data evaluating mortality outcomes in patients after bare metal vs drug eluting stent (DES) placement.
Materials and Methods: Single center retrospective analysis of RC 3-6 patients revascularized with LifeStent® (New Providence, NJ), Supera™ (Abott Vascular, Chicago, IL), Zilver® & Zilver® PTX™ (Cook Medical, Bloomington, IN) stents between January 2013 - May 2019 by 4 physicians (3 Interventional Radiologists, 1 Vascular surgeon) was conducted after IRB approval. Outcome measures include mortality after non-drug coated vs DES placement at 1 & 2 years (primary endpoints) & gender related & stent specific mortality (secondary endpoint). Data analysis was performed using Fisher's exact test. The descriptive analysis of the patients, including cause of death were collected. Patients without followup at the dedicated endpoints were excluded from analysis at each time point, yielding a n =515 at 1 year and n=477 patients at 2 years.
Results: There was no increased mortality signal with the use of paclitaxel DES compared to non-DES with mortality rates at 1 year of 11.0% vs 16.6% (OR: 1.6, CI = 0.98 -2.7) & 16.5% vs 22.4% at 2 years (OR: 1.5, CI = 0.91 - 2.3).
Conclusion: Similar to the outcomes of mortality associated with DES in the setting of patient-level data, our cohort failed to demonstrate an increased mortality signal after exposure to DET. The cohort mirrors real-life clinical compliance rate & although it poses challenges to evolving research efforts such as the study conducted here, it echoes the need for further studies one limb at a time.
References: Dake, M.D., Ansel, G.M., Bosiers, M. et al. Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices. Cardiovasc Intervent Radiol 43, 8–19 (2020). https://doi.org/10.1007/s00270-019-02324-4