With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons.

This is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest.

In total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017).

Patients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States.