Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease
PURPOSE: Understanding the real-world safety of paclitaxel (PTX) coated devices for treating lower extremity peripheral artery disease remains a high clinical priority of the Food and Drug Administration. MATERIALS AND METHODS: Data from FAIR Health, the largest commercial claims data warehouse in the US, was used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. Secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching used to minimize confounding, and Kaplan-Meier methods were used to estimate survival. RESULTS: A total of 10,832 procedures were included in the analysis, including 4962 involving PTX devices and 5870 involving non-PTX devices. PTX-devices were associated with a reduced hazard of death following treatment at 2 and 4 years (Hazard Ratio (HR) 0.74 (0.69-0.79) P<0.05; HR 0.89 (0.77-1.02) Log-Rank P=0.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR 0.82 (0.76-0.87) P=0.02, HR 0.77 (0.67-0.89), Log-Rank P=0.01 respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years. CONCLUSIONS: In the real-world commercial claims database, no short or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.