Improving the Outcomes of Complex Lesions of the Femoropopliteal Artery Using Atherectomy and Drug Coated Balloon.

The femoropopliteal arterial segment is the most common site of disease in patients with peripheral arterial disease and corresponds to the superficial femoral-popliteal (FP) artery in the lower extremities.1)2) Endovascular therapy of the superficial femoral artery is challenging due to the unique dynamic motion of the vessel with daily function, including compression, elongation, flexion, and torsion.3) There are numerous interventional strategies for endovascular repair in the FP lesion, including plain old balloon angioplasty, drug-coated balloons, bare metal and drug eluting stents, covered stents, and atherectomy. With many current options for endovascular treatment, and disparate studies investigating individual devices, it can be difficult to determine if there is a clear standard of care, and variation is quite high.4)

The combination of directional atherectomy and drug coated balloon (DCB) angioplasty is an attractive strategy for FP revascularization because it addresses both major challenges to sustained patency in FP interventions: (1) mechanical forces caused by residual plaque burden or dissections and (2) biologic restenosis due to development of intimal hyperplasia.

The combination of these two modalities has been studied in the DEFINITIVE AR randomized controlled trial for evaluating the directional atherectomy in conjunction with DCB angioplasty.5) This study showed no statistically significant difference in primary patency between combination therapy with atherectomy plus DCB versus DCB alone at 12 months. In the REALITY trial,6) which is a single-arm, core-lab adjudicated study evaluating the combination of the directional atherectomy and DCB angioplasty for long, severely calcified lesions of the FP circulation has been studied. Interim results for the 102 patients in the trial demonstrate a mean lesion length of 17.9 cm and a Peripheral Arterial Calcium Scoring Scale score of 3 to 4 in 76.4% of patients. Interim analysis suggests a bailout stent rate of 4.9%, which is extremely low considering such complex lesions. The COMPLIANCE 360 trial7) investigated orbital atherectomy vs percutaneous transluminal angioplasty and did not report a significant difference in primary patency.

Stavroulakis et al.8) reported that preparation of the atherosclerotic common femoral artery lesion with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from the target lesion revascularization compared to DCB angioplasty alone at 12 months. They showed that both modalities had promising outcomes in a primarily surgically treated vascular territory.

The field of endovascular FP revascularization has clearly made great strides over the past 2 decades; however, major limitations of the current data remain.9) The first is primarily because of the lack of head to head comparisons. The second major limitation of the current evidence is a lack of consensus over consistent clinical definitions of outcome measures, and a general lack of patient-centric measures used in FP intervention studies.

However, from Cha et al.’s study,10) we can find the real outcomes of actual treatments for the FP arterial segments using atherectomy and DCB available in Korea and confirm the insight.