A Retrospective Comparative Study of Twelve-Month Clinical Outcomes for Drug-Coating Balloon Angioplasty and Stent Implantation in Treating Patients with Popliteal Obstructive Lesions.

ABSTRACT

PURPOSE: Despite increased interest in treating superficial femoral and popliteal arteries with endovascular technology, there is little data regarding comparative results of different treatment modalities in the popliteal artery. It was hypothesized that to improve clinical outcomes in this segment, drug-coating balloon (DCB) angioplasty would not be inferior to stent implantation. METHODS: The records of consecutive Chinese patients with popliteal lesions who were treated with DCB or stenting between June 2016 and February 2017 were retrospectively reviewed. The preoperative demographic, lesion characteristics and postoperative outcomes were compared and statistically analyzed. All patients were divided into different subgroups according to the degree of calcium or degree of ischemia. RESULTS: One hundred two consecutive patients with popliteal lesions were treated with DCB or stenting and 95 (93.1%) completed a follow-up. Critical limb ischemia was present in 70.5% and occlusions were present in 61.1% of patients. DCB angioplasty was performed on 43 patients and angioplasty with primary stenting was performed on 52 patients. There was no difference in twelve-month primary patency (79.1% vs 82.7%; P = 0.687), secondary patency (95.3% vs 94.2%; P = 0.808) and amputation-free survival (93.0% vs 94.2%; P = 0.825) between the DCB group and stent groups. In patients with severe calcium, the twelve-month primary patency (61.1% vs. 79.2%; P = 0.239) and amputation-free survival (83.3% vs 87.5%; P = 0.739) did not differ between the DCB and stent groups. CONCLUSIONS: This study demonstrates that DCB treatment in Chinese patients with popliteal atherosclerotic occlusive lesions can be associated with similar twelve-month patency and amputation-free survival compared to stenting, even in patients with severe calcification. LEVEL OF EVIDENCE Level 3a, Non-randomized follow-up study.