Vessel Patency After Femoropopliteal Drug-Coated Balloon Therapy in Patients on Hemodialysis.

BACKGROUND

Drug-coated balloons (DCBs) are widely used as a core treatment for femoropopliteal lesions, but no largescale prospective studies have evaluated DCB in hemodialysis (HD) patients.

OBJECTIVES

The authors sought to clarify restenosis risk and associated factors after DCB therapy for symptomatic femoropopliteal artery disease in patients on HD.

METHODS

We analyzed the database of a multicenter prospective study that registered patients undergoing DCB treatment (either Lutonix or IN.PACT Admiral) from March 2018 to December 2019. Of the 3,165 registered lesions, 991 lesions were in patients on HD. The primary outcome was freedom from restenosis.

RESULTS

The HD group was younger (72 ± 9 years vs 76 ± 9 years) and had a higher frequency of diabetes (76.5% [557/728 patients]) vs 60.8% [1,081/1,779 patients]). The prevalence of chronic limb-threatening ischemia was 52.2% (444/850 patients) vs 22.1% (437/1,977 patients). Lutonix was used in 30.6% (688/991 lesions) vs 21.3% (462/2,174 lesions), and IN.PACT Admiral was used in 69.4% (303/991 lesions) vs 78.7% (1,712/2,174 lesions). After propensity-score matching, the 1- and 3-year rates of freedom from restenosis in the HD and non-HD groups were 82.2% (95% CI: 79.0%-85.3%) vs 85.8% (83.0%-88.7%) at 1 year and 61.9% (57.7%-66.1%) vs 66.3% (62.2%-70.4%) at 3 years, respectively. In the HD group, restenosis occurred in 363 lesions during a median follow-up of 16.2 months (Q1-Q3: 7.2-35.5 months). Factors independently associated with restenosis risk in the HD group were no below-the-knee runoff, history of endovascular therapy, popliteal lesion, severe calcification, use of Lutonix, and severe dissection.

CONCLUSIONS

DCB endovascular therapy is a reasonable treatment for femoropopliteal lesions in patients on HD.