[Clinical efficacy of drug-coated balloon vs plain balloon in the treatment of restenosis after stenting of femoropopliteal artery occlusive disease with complex long segment combined with severe calcification].

Objective: To evaluate the clinical efficacy of drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) for the treatment of in-stenting restenosis (ISR) in patients with complex long-segment combined with severely calcified femoropopliteal artery disease. Methods: This study was a single-center retrospective cohort study that included 124 patients with femoropopliteal artery disease in the Department of Vascular Surgery, Gulou Hospital, Nanjing University School of Medicine, from January 2018 to June 2022. The patients were divided into 2 groups according to the surgical procedure used to treat restenosis: the PTA group (n=59) and the DCB group (n=65). All patients had primary restenosis after stenting, and CTA of both lower extremity arteries was performed after admission to determine the length of the lesion and the degree of calcification. The primary safety endpoints were the rate of adverse cardiovascular events at 30 days (MACEs) and all-cause mortality, the primary clinical endpoints were the 2-year phase Ⅰ patency rate and freedom from clinically-driven target lesion revascularization (FCD-TLR), and the secondary clinical endpoints were amputation-free survival (AFS), major amputation, minor amputation, and secondary open surgery rates. The Kaplan-Meyer (K-M) curves was used to analyze the differences between clinical and safety endpoints between the two groups, and univariate and multivariate Cox regression models were used to analyze the risk factors associated with 2-year phase Ⅰ patency rates in patients with femoropopliteal artery disease. Results: A total of 124 patients were included in this study. There were 41 males and 18 females in the PTA group, aged (73.6±9.7) years, with a mean lesion length of (20.2±10.7) cm, and 76.3% (45/59) of the patients with severe calcification; there were 42 males and 23 females in the drug-coated balloon group, aged (74.7±9.5) years, with a mean lesion length of (17.3±9.2) cm, and 77.0% (50/65) of patients with severe calcification. The PTA group had a significantly higher rate of minor amputations at 24 months than the DCB group [37.3% (22/59) vs 18.5% (12/65), P=0.035]. However, there were no significant differences between the PTA and DCB group in the two-year primary patency [15.3% (9/59) vs 16.9% (11/65)], FCD-TLR [22.0% (13/59) vs 24.6% (16/65)], AFS [33.9% (20/59) vs 41.5% (25/65)], major amputation rate [10.2% (6/59) vs 9.2% (6/65)], second open surgery rate [13.6% (8/59) vs 10.8% (7/65)], 30-day MACEs [1.7% (1/59) vs 1.5% (1/65)] and all-cause mortality [6.7% (4/59) vs 7.6% (5/65)](all P>0.05). Multifactorial Cox regression analysis showed that smoking (HR=1.95, 95%CI: 1.22-3.14, P=0.006) and severe calcification (HR=1.46, 95%CI: 1.30-1.72, P=0.001) were risk factors for reduced primary patency. Conclusion: In patients with ISR of femoropopliteal artery disease associated with complex long segments with severe calcification, DCB can significantly reduce the rate of minor amputation in patients at 2 years compared with plain balloons, but there is no significant differences in other clinical and safety end points between the two treatment modalities.