Vessel Patency After Femoropopliteal Drug-Coated Balloon Therapy in Patients on Hemodialysis.
In the multicenter prospective POPCORN registry, drug-coated balloon therapy for symptomatic femoropopliteal artery disease achieved acceptable vessel patency in hemodialysis patients — 82.2% freedom from restenosis at 1 year and 61.9% at 3 years after propensity matching, modestly lower than non-dialysis patients — supporting DCB as a reasonable treatment in this high-risk group.
Background
Drug-coated balloons (DCBs) are widely used as a core treatment for femoropopliteal lesions, but no large-scale prospective studies had evaluated DCB therapy specifically in patients on hemodialysis. The authors sought to clarify restenosis risk and its associated factors after DCB therapy for symptomatic femoropopliteal artery disease in this population.
Study design
The investigators analyzed a multicenter prospective study database of patients treated with DCB (Lutonix or IN.PACT Admiral) between March 2018 and December 2019. Of 3,165 registered lesions, 991 were in patients on hemodialysis. The primary outcome was freedom from restenosis. Compared with the non-dialysis group, hemodialysis patients were younger (72 vs 76 years), more often diabetic (76.5% vs 60.8%), and far more likely to have chronic limb-threatening ischemia (52.2% vs 22.1%).
Key findings
After propensity-score matching, freedom from restenosis in hemodialysis versus non-dialysis patients was 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. Among hemodialysis patients, restenosis occurred in 363 lesions over a median follow-up of 16.2 months. Factors independently associated with restenosis in the hemodialysis group were absent below-the-knee runoff, prior endovascular therapy, popliteal lesion location, severe calcification, use of the Lutonix balloon, and severe dissection.
Clinical implications
The authors conclude that DCB endovascular therapy is a reasonable treatment for femoropopliteal lesions in patients on hemodialysis, with patency rates only modestly below those of non-dialysis patients. The identified restenosis risk factors — runoff status, lesion location, calcification, device choice, and dissection severity — can inform lesion selection and procedural strategy in this high-risk population.
Category
Research
Source
JACC Cardiovasc Interv
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