OFF-LABEL USE OF DRUG COATED BALLOONS AND STENTS IN PATIENTS WITH FEMOROPOPLITEAL AND ADVANCED CHRONIC KIDNEY DISEASE. INSIGHTS FROM THE VASCULAR QUALITY INITIATIVE

Abstract

Background Safety and efficacy for the use of drug-coated balloons (DCB) and drug-eluting stents (DES) in femoropopliteal artery disease have been demonstrated, but patients with advanced chronic kidney disease (CKD stage 4-5) were excluded from key trials leading to their approval. We examined off-label DCB/DES use in patients with advanced CKD and variability of use across operators. Methods We reviewed all femoropopliteal artery endovascular interventions between 2016 and 2019 from the Vascular Study Group of New England database. We compared DCB/DES use for treated lesions in patients with CKD stage 4-5 vs. those with CKD stage 3 or non-CKD. Variability in DCB/DES vs. plain balloon angioplasty or bare metal stent use across providers was quantified by the median odds ratio (MOR), adjusting for lesion and patient-level factors. Results Of the 31,851 procedures in the dataset, 7,087 femoropopliteal arteries treated by 142 operators were included. CKD stage 4-5 as a comorbidity was present in 940 (13.2%) treated lesions. DCB/DES use in patients with CKD stage 4-5, CKD stage 3 and non-CKD was 38.4%, 44.1%, and 45.1%, respectively (p<0.001). Significant operator variability was observed for off-label DCB/DES use in patients with advanced CKD (adjusted MOR: 2.60, 95% CI: 1.33-3.74) (Figure 1). Conclusion Off-label use of DCB/DES in patients with advanced CKD is common and variable across operators, underscoring the need for safety and efficacy studies targeted towards this vulnerable population. [Formula presented]