Scoring Balloon Reduces the Severity of Dissection and Stent Implantation Rate in Superficial Femoral Artery Angioplasty Compared to Plain Balloon.

ABSTRACT

PURPOSE: The knowledge regarding the benefits of the scoring balloon (SB) in comparison to the plain balloon (PB) is limited. This study aims to elucidate the difference in efficacy between SB and PB as pre-balloon in superficial femoral artery angioplasty. METHODS: We retrospectively analyzed angiographic images of 113 lesions in 98 patients treated with endovascular surgery. 37 lesions were prepared by SB and 76 lesions by PB. Lesions without significant residual stenosis nor a flow-limiting dissection were treated by drug-coated balloon and the others by drug-eluting stent. Severity of dissection was evaluated by Kobayashi dissection grade and NHLBI classification. The rate of stent implantation was compared between the 2 groups. Kaplan-Meier analysis estimated freedom from target lesion revascularization (TLR) rate at 12 months. RESULTS: Severe dissections (>1/3 of lumen) occurred less frequently in the SB group (SB 40.5% vs. PB 75.0%, P = 0.001). Overall stent implantation rate was lower in the SB group (SB 27.0% vs. PB 55.3%, P = 0.005). In subgroup analysis for the complex lesions, the SB group had lower rate of severe dissection(>1/3 of lumen) in patients with long lesions(>15 cm) (SB 51.7% vs. PB 76.9%, P = 0.020) and lesions of calcium grade ≥2 (SB 43.8% vs. PB 72.5%, P = 0.009). SB group had lower stent implantation rate in patients with long lesions (SB 34.5% vs. PB 59.6%, P = 0.030), lesions of calcium grade ≥2 (SB 31.3% vs. PB 56.9%, P = 0.023), and total occlusion (SB 30.8% vs. PB 80.0%, P = 0.002). There were no procedure-related complications in either group except 1 case of puncture-site hematoma. There was no significant difference in TLR rate between both groups at 12 months (P = 0.509). CONCLUSION: SB reduces the incidence of severe dissection (>1/3 of lumen) and rate of overall stent implantation in comparison with PB. The use of SB is a safe and effective method of lesion preparation in SFA angioplasty.