One-year Clinical Outcomes and Predictors of Distal Embolization After JETSTREAM™ Atherectomy for Calcified Femoropopliteal Artery Lesions: Results From the JET-FORWARD Study.

Abstract

Purpose: This study aimed to identify predictors of distal embolization following JETSTREAM™ atherectomy for calcified femoropopliteal lesions and evaluate 1-year clinical outcomes in a real-world setting.

Materials and methods: We analyzed data from 109 patients with 121 calcified femoropopliteal lesions who underwent JETSTREAM™ atherectomy therapy between October 2022 and December 2023 as part of the JET-FORWARD study, a retrospective, single-arm, multicenter study. Distal embolization incidence and risk factors were the primary focus, while 1-year primary patency served as efficacy outcome measures. Safety outcomes also included mortality and major target limb amputation.

Results: The mean lesion length was 15.5 ± 9.4 cm, and the technical success rate-defined as residual stenosis less than 30% and absence of grade C or higher dissection post-procedure-was 93.4%. Angiographically significant distal embolization occurred in 35.5% of cases during the index procedure. On multivariate analysis, poor tibial runoff (≤ 1 tibial artery), severe small artery disease, nodular calcification, and debulking lengths > 10 cm were independent predictors of distal embolization. The 1-month mortality and 1-year limb salvage rates were 2.8% and 98.9%, respectively. The 1-year primary patency rate was 88.9%.

Conclusion: Angiographically significant distal embolization occurred in 35.5% of cases with JETSTREAM atherectomy, while 1-year outcomes remained favorable in treating femoropopliteal lesions. This study also identified four predictors of distal embolization. Thus, careful risk factor evaluation and patient selection are essential during atherectomy.