Background: Despite enhanced immediate technical success, neointimal hyperplasia, stent fracture, and restenosis remain the Achilles heel of endovascular interventions. Aim: To emphasize results of bare metal stenting versus drug eluting balloon in superficial femoral artery occlusive lesions in critical limb ischemia as regard risk factors, tomography of stenotic lesion, associated co-morbidities, patency, success rates, total lesion revascularization and complications .Methods: This prospective randomized controlled study was conducted on 60 patients (81 limbs) complaining of lower limb symptomatic femoro-popliteal atherosclerotic lesions with Age over 40 years; Patients were randomly allocated by using a computer generated random number table into two groups according to the intervention method performed; Group (A); 30 patients (42 limbs) were submitted for treatment with paclitaxel Drug Coated Balloons (DCB) and Group (B); 30 patients (39 limbs) submitted for treatment with Bare Metal Stents (BMS). Follow-up period was for 12-monthes. Results: The Bare Metal Stents (BMS) had lower patency and limb salvage rates compared to patients who received Paclitaxel Drug Coated Balloons (DCB).The primary patency rates were 97.4%, 89.5%, 81.6%at 1, 6, 12 months respectively in group (A) Vs 97.4%, 78.9%, 77.8% at 1, 6, 12 months respectively in group (B), there was no 30 days mortality in both groups except 2 patient mortality in group (A) due to cardiac problems and the patients didn't need any re-intervention procedures in the 1st month except one limb (2.6%) in group (A); but Clinically TLR rates were 10.5%, 18.4% at 6, 12 months respectively in group (A) Vs 15.9%, 22.2% at 6, 12 months respectively in group (B). there was one major amputation (2.6%) in group (B) due to spreading infection despite presence of pedal pulse. Conclusion: Paclitaxel Drug Coated Balloons (DCB) seems to have a promising very important role in prevention of restenosis and recurrence of peripheral arterial occlusive disease. however; the stents still playing important bailout role in the treatment of peripheral arterial occlusive disease. |
