Background: Bare metal stent (BMS) scaffolding of superficial femoral artery occlusive lesions has been associated with high rates of late clinical failure. Maintaining the patency of recanalized arterial segments was the main issue behind the concept of leave nothing behind to be evolved and balloon angioplasty becomes preferred option for endovascular therapy. Drug eluting balloons (DEBs) have shown to be effective alternative to BMS for patients with de novo complex superficial femoral occlusive disease. Purpose: To compare the outcome of DEB versus BMS in treating complex chronic total occlusion (CTO) of superficial femoral and proximal popliteal artery in patients with disabling claudication and critical limb ischemia regarding technical success, primary patency, clinically driven target lesion revascularization (cd-TLR), and limb salvage rate. Patients and methods: 90 patients (110 limbs) were complaining of disabling and critical limb ischemia due to complex femoro-popliteal occlusive lesions were were rand randomly allocatedomly allocatedomly allocatedomly allocatedomly allocatedomly allocated omly allocatedomly allocatedomly allocated omly allocated into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the into two groups according to the interventioninterventioninterventionintervention intervention interventioninterventioninterventionintervention method method method method method method performed.performed. performed. performed. performed. Group (A); 48 patients (57 limbs) were submitted for treatment with paclitaxel DEB and Group (B); 42 patients (53 limbs) submitted for treatment with BMS. Follow FollowFollowFollowFollow-up period was forup period was forup period was for up period was forup period was forup period was for up period was for up period was for 1, 6 and6 and 12 .
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Results: BMS seems to have lower patency and higher cd-TLR rates compared to patients who received Paclitaxel DCBs but not statistically significant. The primary patency rates were 100%, 96%, 86.2%at 1, 6, 12 months respectively in DEB group, Vs 100%, 89.8%, 77.6% at 1, 6, 12 months respectively in BMS group. TLR rates were 2%, 7.8% at 6, 12 months respectively in DEB group Vs 6.1%, 14.2% at 6, 12 months respectively in BMS group. Conclusions: Percutaneous therapy for TASC C and D femoro-popliteal lesion using DEB or BMS are both safe and effective with one-year high patency rate. Paclitaxel DEBs seem to have a promising important role in prevention of restenosis and recurrence of peripheral arterial occlusive disease. However, stents are still playing important bailout role in the treatment of residual stenosis and dissection. Further Further FurtherFurther follow-up is essential to obtain and document long-term outcome of percutaneous therapy for complex and long SFA lesions. |
