Abstract Background Endovascular therapy (EVT) with a paclitaxel-based strategy, including drug-coated balloons (DCBs) and drug-eluting stents (DESs), is widely applied to treat femoropopliteal (FP) lesions. However, it is unclear whether a paclitaxel-based strategy is the most effective revascularization strategy for patients with chronic limb-threatening ischaemia (CLTI) associated with FP lesions. Purpose The aim of the current study was to investigate the clinical impact of EVT with paclitaxel-based strategy on amputation-free survival (AFS) for FP lesions in CLTI. Methods This multicentre, retrospective study included 1,470 CLTI patients that underwent EVT with plain old balloon angioplasty (POBA), bare metal stents (BMSs), DCBs, or DESs for FP lesions between April 2010 and March 2023. We divided into two groups: the paclitaxel-based strategy group (group P: DCBs and DESs) and the non-paclitaxel-based strategy group (group NP: POBA and BMSs). The primary endpoint was one-year AFS rate assessed by Kaplan-Meier analysis with propensity score matching. Results The group P and NP included 509 and 961 patients, respectively. The propensity score matching extracted 201 pairs. Kaplan-Meier analysis revealed significantly higher one-year AFS rate in group P compared to group NP before matching, whereas, the difference was disappeared after matching (80.0% vs. 78.8%, Log-rank p = 0.662) (Figure). Conclusion A paclitaxel-based strategy did not significantly improve the AFS rate in patients with CLTI associated with FP lesions.
Nohara et al. (Sat,) studied this question.