Analysis of the impact of nodular calcification on clinical outcome after drug-coated balloon angioplasty for femoropopliteal lesions

Purpose: This study aimed to reveal the impact of nodular calcification (NC) on restenosis risk in patients undergoing femoropopliteal drug-coated balloon (DCB) angioplasty for symptomatic atherosclerotic peripheral artery disease. Methods: We retrospectively analyzed 568 patients who underwent endovascular therapy with DCB for de novo femoropopliteal lesions under intravascular ultrasound guidance between November 2017 and February 2021 at seven cardiovascular centers in Japan. Patients with lesions without calcification were excluded from the study. The patients were classified into two groups based on the presence or absence of NC: the NC [+] group (n=200) and the NC [-] group (n = 368). The main outcome was the primary patency at 3 years. Cox proportional hazards analysis was used to determine whether NC was an independent predictor of clinical outcomes. Results: The 3-year primary patency rates were significantly lower in the NC [+] group than in the NC [-] group (53.8% vs. 65.8%, p=0.001). After multivariate analysis, the presence of NC was independently associated with restenosis risk; the adjusted hazard ratio was 1.61 (95% confidence interval 1.15 to 2.26, p=0.006). Conclusion: The NC is an independent predictor of restenosis in patients undergoing DCB angioplasty for femoropopliteal lesions. Patients with NC had a significantly lower primary patency, highlighting their negative impact on clinical outcomes. Further research is required to establish evidence-based strategies for managing calcified femoropopliteal lesions.