VOYAGER PAD looked at the long-term safety of drug-coated devices (DCD) in peripheral artery revascularization. This study enrolled 6,564 patients and 66 percent (n=4,316) underwent index endovascular lower extremity revascularization (LER). Among the patients undergoing endovascular LER, 1,342 were treated with DCD and 2,974 were treated with non-DCD. In the unweighted analysis, lower associated mortality was observed among patients receiving DCD versus non-DCD (2.9 vs. 3.9 per 100 patient years; 3.5-year Kaplan-Meier cumulative incidence of 10.2% vs. 13.8%). The weighted analysis showed drug-coated devices were not associated with an increase (or decrease) in mortality compared with non-drug-coated devices (3.5-year cumulative incidence 12.1% vs. 12.6%, HR 0.95, 95% CI 0.83-1.09, p=0.49). Rivaroxaban was beneficial at reducing major adverse cardiac and limb events, irrespective of drug-coated device use. These takeaways build on important research related to the safety of drug-coated devices. Currently, in response to data suggesting a mortality increase with the use of drug-coated devices, the FDA has placed a warning on the use of these devices.
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