Clinical Outcomes of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon Alone in the Treatment of Femoropopliteal Artery Disease.

ABSTRACT

BACKGROUND AND OBJECTIVES: Atherectomy as a pretreatment has the potential to improve the outcomes of drug-coated balloon (DCB) treatment by reducing and modifying atherosclerotic plaques. The present study investigated the outcomes of atherectomy plus DCB (A+DCB) compared with DCB alone for the treatment of femoropopliteal artery disease. METHODS: A total of 311 patients (348 limbs) underwent endovascular therapy using DCB for native femoropopliteal artery lesions at two endovascular centers. Of these, 82 limbs were treated with A+DCB and 266 limbs with DCB alone. After propensity score matching based on clinical and lesion characteristics, a total of 82 pairs was compared for immediate and mid-term outcomes. RESULTS: For the matched study groups, the lesion length was 172.7±111.2 mm, and severe calcification was observed in 43.3%. The technical success rate was higher in the A+DCB group than in the DCB group (80.5% vs. 62.2%, p=0.015). However, the A+DCB group showed more procedure-related minor complications (37.0% vs. 13.4%, p=0.047). At 2-year follow-up, primary clinical patency (73.8% vs. 82.6%, p=0.158) and the target lesion revascularization (TLR)-free survival (84.3% vs. 88.2%, p=0.261) did not differ between the two groups. In Cox proportional hazard analysis, atherectomy showed no significant impact on the outcome of DCB treatments. CONCLUSIONS: The pretreatment with atherectomy improved technical success of DCB treatment; however, it was associated with increased minor complications. In this study, A+DCB showed no clinical benefit in terms of TLR-free survival or clinical patency compared with DCB treatment alone.