The Limb Salvage PAteNcy Rate After Directional Atherectomy Combined With Drug-Coated Balloon Angioplasty in Lower Extremities: PANDA Trial

Abstract

Background:

Peripheral artery disease (PAD) is a critical vascular condition characterized by arterial occlusions, primarily in the lower extremities, leading to significant morbidity. The aim of this study is to investigate the clinical outcomes after directional atherectomy combined with drug-coated balloon angioplasty in lower extremity arterial disease.

Methods:

The PANDA study is a prospective, single-arm trial that evaluated the effectiveness of the TurboHawk Plaque Excision System (THPRS) combined with drug-coated balloon (DCB) angioplasty in 96 patients with femoral-popliteal lesions. The study aimed to assess the patency rates and clinical outcomes over a follow-up period of at least 12 months.

Results:

The overall 1-year patency rate was 88.2%±3.7% and 2-year patency rate was 74.8%±5.5%. The overall 1-year free from target lesion revascularization (TLR) rate was 90.8%±3.3% and 2-year free from TLR rate was 82.5%±4.7%. The 1-year patency rate for calcified versus noncalcified lesions was 87.6%±5.2% versus 89.0%±5.2%, and the 2-year patency rate was 68.3%±8.2% versus 82.4%±6.6% (p=0.085). The 1-year free from TLR rate for calcified versus noncalcified lesions was 87.6%±5.2% versus 94.3%±3.9%, and the 2-year free from TLR rate was 77.9%±7.0% versus 87.3%±6.0% (p=0.249). The 1-year patency rate for long versus short lesions was 86.5%±5.1% versus 90.5%±5.2%, and the 2-year patency rate was 67.1%±7.7% versus 85.2%±7.1% (p=0.094). The 1-year free from TLR rate for long versus short lesions was 93.3%±3.8% versus 87.6%±5.8%, and the 2-year free from TLR rate was 78.0%±7.1% versus 87.6%±5.8% (p=0.434).

Conclusion:

The application of THPRS demonstrates good safety and efficacy, and may offer a viable option advantages in long and calcified lesions.

Clinical Impact

The PANDA Trial demonstrates that directional atherectomy (TurboHawk) combined with drug-coated balloon (DCB) angioplasty achieves high 1- and 2-year patency rates (88.2% and 74.8%, respectively) in femoropopliteal lesions, with low bailout stenting (3.7%) and TLR rates (17.1%). This approach may offer distinct advantages for long (>25 cm) and calcified lesions, where traditional DCB angioplasty alone faces mechanical limitations. For clinicians, this supports atherectomy as an adjunct to DCB in complex PAD, potentially reducing restenosis and stent dependency. The innovation lies in plaque debulking before DCB, optimizing drug delivery and vessel compliance. These findings advocate for broader adoption of combined atherectomy-DCB strategies in challenging lower extremity revascularizations.

Keywords

peripheral artery disease TurboHawk plaque excision system femoral-popliteal lesions calcified lesions long lesions

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