Prospective, multicenter study of rotational atherectomy with antirestenotic therapy for infrainguinal arterial disease.

OBJECTIVES: Thrombi are common in steno-occlusive lesions of infrainguinal atherosclerotic diseases. Despite the easy passage of guidewires through these lesions, conventional ballooning or stenting cannot effectively treat them, and patients are at risk of distal embolization. This study aimed to investigate the clinical outcomes of using a rotational aspiration atherectomy system to treat infrainguinal atherosclerotic disease.

METHODS: Patients underwent revascularization of target lesions using the Jetstream™ Atherectomy System. The primary endpoint was the freedom from clinically driven target lesion revascularization (CD-TLR) 12-month after the procedure. Outcomes were evaluated according to the clinical severity, lesion type, use of drug-coated balloons (DCB), and lesion length, characteristics, and sites. Survival analysis for CD-TLR over time was plotted. All statistical analyses were performed using SPSS version 22 (IBM; Armonk, NY, USA). p-values < .05 were considered statistically significant.

RESULTS: In total, 150 patients (91.2% male; mean age, 69.8 years; 66.2% with diabetes) with de novo or restenotic infrainguinal lesions were enrolled. The mean lesion length was 17.2 cm, 75.0% were occlusive, and 38.2% had severe calcification. The lesion types were sclerotic (64.7%), thrombosclerotic (20.6%), thrombotic (8.8%), and in-stent (5.9%). Adjunctive DCB was used in 86.8% of patients. The 12-month primary patency rate (PPR) and CD-TLR rates were 81.6% and 90.1%, respectively. The 12-month CD-TLR rate was significantly better in the sclerotic and thrombosclerotic groups than in the thrombotic group (100% and 100% vs. 66.7%; p = .001). The 12-month PPR was significant better in TASC A and B groups than TASC C and D groups (p=.02). The 12-month PPR is significantly better after using a drug-coated balloon or stent placement than after using a simple balloon (p = .01). There were no major adverse events, including procedure-related death, myocardial infarction, or major amputation.

CONCLUSIONS: The results of this study demonstrated the safety and effectiveness of the Jetstream™ atherectomy device for complex infrainguinal lesions. This system functions optimally with TASC A/B lesions and sclerotic or thrombosclerotic lesions.