Long-term Evidence of Directional Atherectomy and DCB: 3-Year Clinical Experience from Australia

On Monday, June 6, during a session that focused on novel approaches and insights for treatment of complex femoropopliteal disease, Dr. Vikram Puttaswamy, from Sydney Vascular Surgery in Australia, spoke to attendees about the results of a 3-year study on directional atherectomy and drug-coated balloons. “I have been performing vascular surgical procedures for 20 years in a teaching hospital setting in Sydney,” he began. “By 2016, I was using paclitaxel-based treatments as they had a clear advantage over their alternatives.” However, many of his patients were having regular reinterventions and critical limb ischemia (CLI) patients were requiring major amputations on a regular basis. At that time, atherectomy was just coming into use in Australia, and Dr. Puttaswamy wondered which system to use and how best to use it.

The Definitive LE trial showed that directional atherectomy using the Hawk system was useful in treating not only superficial femoropopliteal disease but infrapopliteal vessels as well. The Definitive AR trial showed that the combination of direct atherectomy with paclitaxel-based angioplasty was potentially very effective. “It made sense that I could use this combination treatment with my patient group,” he said, and in late 2016 he established a single-arm, prospective registry of patients with infralingual arterial disease requiring intervention with the TurboHawk or HawkOne atherectomy devices (Medtronic).

The patients were followed up postoperatively at 1, 3, and 6 months, then further regular intervals with clinical review and duplex ultrasound. Angiograms were assessed for reinterventions, and independent assessors performed the assessment of clinical records, imaging, and statistical analysis. Both 6 F and 7 F systems were used, and a SpiderFX embolic protection device (Medtronic) was used in all cases. A total of 289 patients were treated with directional atherectomy from October 2016 to June 2021, with 747 procedures performed on 877 separate lesions in native arteries and 102 in-stent SFA and popliteal arteries. Technical success was achieved in most patients. Primary patency in the SFA/popliteal lesion group was 92.5% at 6 months, 86.8% at 1 year, 74.7% at 2 years, and 71.4% at 3 years. Freedom from TLR in this group was 87.2% at 1 year, 72.1% at 2 years, and 63.8% at 3 years. Primary patency of SFA/popliteal in-stent lesions was 86.2% at 1 year, 70.5% at 2 years, and 63.2% at 3 years. Primary patency of the entire tibial cohort was 67% at 1 year, 53.2% at 2 years, and 44.4% at 3 years. Freedom from TLR in this group was 80.5% in 1 year, 71.5% in 2 years, and 64.1% in 3 years.

In the entire cohort, there were target vessel complications in only 2.39% and bail-out stenting in only 0.57%. Most important, there were no amputations. “Combination treatment of paclitaxel-based DCB with HawkOne directional atherectomy has a definite role in treating all supramalleolar infrainguinal arteries,” Dr. Puttaswamy concluded. “If performed effectively and in conjunction with a robust surveillance program, it can lead to very low major amputation rates in CLI patients.”