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.
Method(s): 90 patients (110 limbs) were complaining of disabling and critical limb ischemia
due to complex femoro-popliteal occlusive lesions were randomly allocated into two
groups according to the intervention method 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-up period was for 1, 6 and 12.
Result(s): 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. Conclusion(s): 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 follow-up is essential
to obtain and document long-term outcome of percutaneous therapy for complex and long
SFA lesions.
