Prospective, Multicenter Study of Rotational Atherectomy with Antirestenotic Therapy for Infrainguinal Arterial
Hyung-Kee Kim1, Jaehoon Lee2, Woo-Sung Yun1
1Department of Surgery, Kyungpook National University Chilgok Hospital, Kyungpook National University School of Medicine, Daegu, South Korea.
Insights
Rotational aspiration atherectomy effectively treats complex infrainguinal atherosclerotic disease, showing high patency rates. The Jetstream system is safe and optimal for TASC A/B and thrombosclerotic lesions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Atherosclerosis Research
Background:
- Infrainguinal atherosclerotic disease often presents with steno-occlusive lesions containing thrombi.
- Conventional treatments like ballooning or stenting are limited and pose risks of distal embolization.
- Rotational aspiration atherectomy offers a potential solution for these challenging lesions.
Purpose of the Study:
- To evaluate the clinical outcomes of using the Jetstream™ Atherectomy System for infrainguinal atherosclerotic disease.
- To assess the safety and effectiveness of this atherectomy system in complex lesion treatment.
- To identify patient and lesion characteristics associated with optimal outcomes.
Main Methods:
- A prospective study involving 150 patients with infrainguinal lesions treated with the Jetstream™ Atherectomy System.
- Primary endpoint: freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months.
- Outcomes analyzed based on lesion type, TransAtlantic Inter-Society Consensus (TASC) classification, use of drug-coated balloons (DCBs), and lesion characteristics.
Main Results:
- The 12-month primary patency rate was 81.6%, and CD-TLR was 90.1%.
- Outcomes were significantly better for sclerotic/thrombosclerotic lesions compared to thrombotic lesions (P=0.001).
- Higher patency was observed in TASC A/B lesions and with adjunctive DCB use or stent placement.
Conclusions:
- The Jetstream atherectomy device is safe and effective for treating complex infrainguinal lesions.
- Optimal performance was noted in TASC A/B lesions and those with sclerotic or thrombosclerotic characteristics.
- This approach offers a viable treatment option, minimizing risks associated with conventional methods.
Background:
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 (DCBs), 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 <0.05 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 = 0.001). The 12-month PPR was significant better in TransAtlantic Inter-Society Consensus (TASC) A and B groups than TASC C and D groups (P = 0.02). The 12-month PPR is significantly better after using a DCB or stent placement than after using a simple balloon (P = 0.01). 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.
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