Background: Critical Limb Ischemia (CLI) often causes disabling symptoms of pain and can lead to loss of the affected limb. It is also associated with increased risk of myocardial infarction, stroke and death from cardiovascular disease.
Objective: To compare between drug coated balloons (DCB) and standard percutaneous transluminal angioplasty (PTA) for management of femoral artery disease in critical lower limb ischemia and its preliminary results.
Patients and methods: A prospective single blinded randomized study conducted on 40 patients with femoro-popliteal arterial occlusive disease between May 2017 and May 2019 at the Department of Vascular Surgery in Al-Azhar University and Military Armed Forces Hospitals.
Results: No major adverse events were reported in either arm apart from the minimal occurrence of puncture site haematoma (1 case in either arm which resolves spontaneously necessitating no surgical intervention), allergic reactions (1 case in the PTA group) and transient increase in renal function (2 cases in PTA group and 1 case in DCB group).
During the 12-month follow-up period, 1 patient in the drug coated balloon group died because of multiple organ failure due to severe sepsis, another patient in the uncoated balloon group died due to heart failure. One case in the DCB group ended with above knee amputation compared with two cases in the PTA group.The 12-month primary patency rate was 85% in the DCB arm versus 55% in the PTA arm (P<0.001). The DCB-treated patients demonstrated lower rates of clinically driven target lesion revascularization versus PTA-treated patients through 12 months (5% versus 25%; P<0.001). A significantly higher primary sustained clinical improvement (85%) was observed in the DCB arm in comparison with the PTA arm (60%) (P<0.001).
Conclusion: The DCB demonstrated impressive patency rates with low repeat revascularization rates in comparison with other conventional balloons.