Three-year outcomes of a prospective, multicenter study of rotational atherectomy with antirestenotic therapy for infrainguinal arterial disease.

Purpose: Atherosclerotic plaques in peripheral arterial disease (PAD) include fatty, mixed, and calcified types. Plaque burden is significantly associated with restenosis, reintervention, and amputation-free survival. Rotational and aspirational atherectomy (RAA) may effectively remove such plaques. This study aimed to evaluate long-term outcomes of RAA for infrainguinal PAD. Methods: Patients with infrainguinal lesions underwent revascularization using the Jetstream Atherectomy System (Boston Scientific). This 60-month extension assessed primary patency rate (PPR) and clinically driven target lesion revascularization (CD-TLR). Kaplan-Meier curves were used for survival analysis; P < 0.05 was considered statistically significant. Results: A total of 150 patients (mean age, 70.9 years; male, 86.0%; 65.4% with diabetes) were enrolled. The mean lesion length was 15.8 cm, with 74.0% occlusions and 47.3% severe calcification. Lesions were sclerotic (72.4%), thrombosclerotic (13.4%), thrombotic (9.4%), or in-stent (4.7%). A drug-coated balloon (DCB) was used in 85.5% of cases. PPR at 1, 3, and 5 years was 84.1%, 68.1%, and 58.5%, respectively. CD-TLR rates were 93.0%, 81.5%, and 67.4%, respectively. The benefit of DCB was sustained through 3 years but attenuated thereafter, highlighting the need for extended follow-up in infrainguinal interventions. Conclusion: RAA demonstrated durable 5-year patency and safety outcomes. Device type, DCB use, lesion morphology, and calcium grade did not significantly influence long-term results. Lesion complexity remains the primary predictor of clinical outcome. Despite the complexity of infrainguinal lesions, the use of RAA demonstrated sustained patency through 3 years, with lesion complexity (particularly TASC classification) emerging as the most critical predictor of long-term success.