BACKGROUND: Paclitaxel-eluting technologies improve the clinical outcome of femoropopliteal (FP) occlusive disease. Several studies reported efficacy of the high-dose (nominal paclitaxel density of 3.5 μg/mm2) drug-coated balloon (DCB) for complex FP lesions. However, previous studies of DCB have shown a high rate of bailout stents, and few studies have compared the high-dose DCB with successful lesion pre-dilation without bailout stent and drug-eluting stent (DES) in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare the clinical outcome of high-dose DCB with successful lesion preparation and DES in CTO of the SFA. METHODS: This was a single-center, retrospective study. From June 2018 to November 2020, we compared 41 patients (43 lesions) treated with high-dose DCB and 36 patients (37 lesions) treated with DES. The study period was defined as the period after DCB and DES became available simultaneously at our hospital, when all surviving patients had at least 1 year of follow-up. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from: (1) clinically driven target lesion revascularization (CD-TLR), and (2) re-occlusion. RESULTS: Baseline clinical data were comparable between the two groups. Reference vessel diameter was smaller in the DCB group. The mean lesion and occlusion lengths were about the same in both groups. The subintimal angioplasty and bailout stent rate was 0% in the DCB group. The Kaplan-Meier estimate for 12-month primary patency was 92.0% in the DCB group and 87.2% in the DES group (p = 0.47). Freedom from CD-TLR also did not differ significantly between the two groups. The 12-month freedom from re-occlusion rate tended to be higher in the DCB group than in the DES group. CONCLUSIONS: High-dose DCB with successful lesion preparation showed 12-month clinical outcomes comparable with DES for CTO of the SFA, even without bailout stents.
BACKGROUND: Paclitaxel-eluting technologies improve the clinical outcome of femoropopliteal (FP) occlusive disease. Several studies reported efficacy of the high-dose (nominal paclitaxel density of 3.5 μg/mm2) drug-coated balloon (DCB) for complex FP lesions. However, previous studies of DCB have shown a high rate of bailout stents, and few studies have compared the high-dose DCB with successful lesion pre-dilation without bailout stent and drug-eluting stent (DES) in chronic total occlusion (CTO) of the superficial femoral artery (SFA). This study aimed to compare the clinical outcome of high-dose DCB with successful lesion preparation and DES in CTO of the SFA. METHODS: This was a single-center, retrospective study. From June 2018 to November 2020, we compared 41 patients (43 lesions) treated with high-dose DCB and 36 patients (37 lesions) treated with DES. The study period was defined as the period after DCB and DES became available simultaneously at our hospital, when all surviving patients had at least 1 year of follow-up. The primary endpoint was 12-month primary patency. The secondary endpoints were 12-month freedom from: (1) clinically driven target lesion revascularization (CD-TLR), and (2) re-occlusion. RESULTS: Baseline clinical data were comparable between the two groups. Reference vessel diameter was smaller in the DCB group. The mean lesion and occlusion lengths were about the same in both groups. The subintimal angioplasty and bailout stent rate was 0% in the DCB group. The Kaplan-Meier estimate for 12-month primary patency was 92.0% in the DCB group and 87.2% in the DES group (p = 0.47). Freedom from CD-TLR also did not differ significantly between the two groups. The 12-month freedom from re-occlusion rate tended to be higher in the DCB group than in the DES group. CONCLUSIONS: High-dose DCB with successful lesion preparation showed 12-month clinical outcomes comparable with DES for CTO of the SFA, even without bailout stents.