The Clinical Outcome of Drug-Coated Balloon Following Jetstream and Drug-Coated Balloon for Femoropopliteal Nodular Calcification Lesions: The Results of the Multicenter ORION Study.

BACKGROUND

Nodular calcification (NC) lesions in the femoropopliteal artery (FPA) are associated with poor outcomes after drug-coated balloon (DCB) angioplasty due to inadequate expansion and limited drug uptake. Jetstream atherectomy may enhance vessel preparation and improve DCB efficacy; however, the clinical outcome for FPA NC lesions remains unclear.

AIMS: To compare the efficacy of DCB following Jetstream versus DCB alone for FPA NC lesions in a real-world setting.

METHODS

In this retrospective, multicenter study, we enrolled 2213 consecutive patients (2294 de novo FPA lesions) who underwent EVT between 2018 and 2023. Of these, 94 FPA NC lesions with DCB following Jetstream and 197 FPA NC lesions with DCB alone were analyzed. Propensity score matching was performed to compare clinical outcomes between the two strategies, and 76 pairs were analyzed. The primary outcome was primary patency at 1 year, and target lesion revascularization (TLR) was also evaluated.

RESULTS

At 1 year, DCB following Jetstream achieved significantly higher primary patency and freedom from TLR compared with DCB alone (DCB following Jetstream vs. DCB alone: 87.5% vs. 70.9%, p = 0.017; 95.7% vs. 84.6%, p = 0.047, respectively). Limb salvage and overall survival did not differ significantly between the two groups.

CONCLUSIONS

DCB following Jetstream showed better clinical outcomes compared to DCB alone for FPA NC lesions in a real-world setting.