One-Year Outcomes and Additive Risk of Restenosis After Rotational Atherectomy Plus Drug-Coated Balloon Angioplasty for Calcified Femoropopliteal Lesions in a Japanese Population.

Purpose

To evaluate 1-year clinical outcomes and identify predictors of restenosis after rotational atherectomy and drug-coated balloon (DCB) angioplasty for calcified femoropopliteal lesions.

Materials And Methods

This retrospective, multicenter, single-arm study included 241 patients (178 men [73.9%] and 63 women [26.1%]) treated with JETSTREAM atherectomy and DCB angioplasty at eight Japanese centers. Mean lesion length was 16.5 cm, 28.6% were chronic total occlusions, and 91.3% had PACSS grade 3/4 calcification. Primary patency was freedom from restenosis (duplex ultrasonography-derived peak systolic velocity ratio >2.4 or occlusion) and clinically driven target lesion revascularization (CD-TLR). At 1 year, 220 patients (91.3%) completed follow-up.

Results

One-year primary patency and freedom from CD-TLR were 85.5% and 91.3%, respectively. Exploratory multivariable analysis identified hemodialysis (HR 2.70, 95% CI 1.27-5.77, P = 0.01), chronic total occlusion (HR 2.85, 95% CI 1.39-5.83, P < 0.01), prior endovascular therapy (HR 5.08, 95% CI 2.48-10.4, P < 0.01), and popliteal artery involvement (HR 3.62, 95% CI 1.76-7.46, P < 0.01) as independently associated with patency loss. Patency declined from 94.1% with ≤1 factor to 38.1% with ≥3 factors. Neither severe nor nodular calcifications were associated with patency loss. Among restenotic lesions, 54.8% were occlusive, and shorter than baseline lesions. Angiographic distal embolization occurred in 37.8% and remained unresolved in 3.3%.

Conclusion

One-year primary patency was 85.5%. Exploratory analyses suggested an additive association between clinical and anatomical factors and loss of patency. These findings require confirmation given the single-arm design and limited number of patency-loss events.