Clinical outcomes in patients with CLTI after femoropopliteal intervention with a drug-coated balloon or stenting.

Abstract

Background: Endovascular treatment (EVT) for patients with an occlusive lesion of the femoropopliteal artery is performed worldwide due to its effectiveness. However, lesions in chronic limb-threatening ischemia (CLTI) are complex and a major concern in superficial femoral artery (SFA) EVT. Despite this, a detailed study of SFA EVT, and especially selection of the final device as a drug-coated balloon (DCB) or a stent, has not been performed in patients with CLTI.

Objectives: To compare the clinical outcomes of SFA EVT using a DCB or a stent in patients with CLTI.

Methods: A multicenter retrospective observational study was performed at 21 Japanese centers. Comparisons were made between patients undergoing initial SFA EVT with a DCB or stenting after inverse probability of treatment weighting (IPTW) using the propensity score to control for potential confounding (patient demographics, comorbidities, medications, and procedural details). The primary outcome measure was major adverse limb events (MALE). We adopted cause-specific hazard models, using Fine and Gray's proportional hazards model in which death was treated as a competing risk. Secondary outcome measures were also evaluated: 1) technical success, 2) slow flow, 3) death within 30 days, 4) major adverse events within 30 days, 5) restenosis, 6) target lesion revascularization (TLR), 7) acute occlusion, 8) wound healing, 9) major amputation, and 10) all-cause mortality.

Results: The study included 900 CLTI cases that underwent EVT with a DCB (n=458) or stenting (n=442) and had a median follow-up period of 17.5 (interquartile range, 6.2-31.9) months. The DCB group had a lower risk of MALE than the stent group, with a hazard ratio of .68 (95% confidence interval (CI), .52-.89; P=.005). Subsequent analysis for the secondary outcome measures demonstrated that the DCB group had a higher prevalence of postprocedural slow flow and a lower incidence rate of acute occlusion (both P < .005 after Bonferroni correction).

Conclusions: DCB angioplasty had a lower risk of MALE than stenting. These results suggest that a DCB might be more beneficial in initial SFA intervention in patients with CLTI.