Midterm outcome of directional atherectomy versus plain balloon angioplasty with adjunctive stenting for femoropopliteal artery lesions: A single-center experience

OBJECTIVE: To examine the difference in safety and effectiveness of directional atherectomy (DA) and plain balloon angioplasty with adjunctive stenting (BA-STENT) in the treatment of de novo femoropopliteal artery occlusive lesions. MATERIALS AND METHODS: This prospective, randomized trial of DA versus BA-STENT in femoropopliteal arteries was carried out in a single medical center. Demographic data, procedural characteristics, and follow-up information were recorded. The technical, procedural, and clinical outcomes were reported. The primary endpoint was the primary stenosis-free patency rate at 12 and 18 months after the intervention. The secondary endpoints included the rates of technical success, freedom from clinically driven target lesion revascularization (TLR), limb amputation, and all-cause mortality. RESULTS: A total of 188 patients were included in this study. The DA group consisted of 89 (47.3%) patients, and the BA-STENT group consisted of 99 (52.7%) patients. There were 134 males and 54 females with an average age of 68 years, all of which had lesions of Rutherford Grade 2 and above. There was no statistically significant difference in age, gender, smoking, or comorbidities between two groups. The technical success rates were 98.9% in the DA group and 100% in the BA-STENT group (P = 0.47). There was no statistically significant difference in primary stenosis-free patency (90.0% vs. 90.6% at 6 months, 76.7% vs. 77.8% at 12 months, and 72.3% vs. 68.9% at 18 months after the intervention) or freedom from TLR (96.3% vs. 95.8% at 6 months, 88.3% vs. 91.6% at 12 months, and 86.1% vs. 85.4% at 18 months after the procedure) between the DA and the BA-STENT groups. There was no statistically significant difference in terms of distal embolization, thrombosis, and mortality between two groups. No patient underwent major amputation. CONCLUSION: For the treatment of de novo Trans-Atlantic Inter-Society Consensus (TASC) II A-C femoropopliteal artery lesions, DA demonstrated comparable results with the plain balloon angioplasty with adjunctive stenting.