Abstract
BACKGROUND: Drug-delivering devices have shown efficacy in clinical trials and are widely used for femoropopliteal artery disease. However, the optimal strategy for complex lesions, such as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, remains debated in real-world practice. This propensity score-matched study aimed to compare the mid-term outcomes between a double-drug strategy [drug-coated balloon (DCB) combined with systemic drug-eluting stents (DES)] and a DCB bailout strategy (DCB with bailout bare-metal stents) in patients with TASC C and D femoropopliteal lesions. METHODS: This retrospective single-center study included TASC C and D femoropopliteal patients treated with DCB from October 2016 to July 2024. Propensity score matching (PSM) was performed in a 1:3 ratio, with one patient in the double-drug strategy group for every three in the DCB bailout group. The primary endpoint was 24-month primary patency. Secondary endpoints included freedom from clinically-driven target lesion revascularization (CD-TLR), mortality, complications, symptom improvement, and risk factors for restenosis. RESULTS: After PSM, 32 pairs of patients were analyzed. Baseline characteristics were well-balanced [standardized mean difference (SMD) <0.2 for all covariates]. Primary patency rates at 24 months were comparable (double-drug vs. DCB bailout: 64.5% vs. 76.4%, P=0.76). Freedom from CD-TLR showed no significant difference at 24 months (double-drug vs. DCB bailout: 95.8% vs. 79.1%, P=0.20). The double drug group demonstrated superior Rutherford category improvement (P=0.042). Mortality and complication rates were similar between groups. Dyslipidemia was identified as an independent predictor of loss of primary patency [hazard ratio (HR) =3.03, P=0.024]. CONCLUSIONS: The double-drug strategy and DCB bailout strategy yielded comparable 24-month patency and freedom from target lesion revascularization (TLR) in TASC C and D lesions.