Purpose
To assess superiority of paclitaxel drug-coated balloons (DCB) in prevention of
neointimal hyperplasia and restenosis after treatment of symptomatic superficial
femoral artery (SFA) occlusive lesions.
Background
Endovascular treatment (ET) has become the first choice for SFA atherosclerotic
lesions. Despite enhanced immediate technical success, neointimal hyperplasia
and restenosis remain the Achilles heel of ET.
Patients and methods
This prospective randomized controlled two-arm blind interventional study was
conducted on 134 patients with symptomatic SFA atherosclerotic lesions. Patients
were randomly allocated by using simple random allocation method, where 134
cards were used for allotment of cases into two groups (67 patients were assigned
to group A, in which patients were subjected to treatment with paclitaxel DCB and
other 67 were assigned to group B, where patients were subjected to treatment with
plain old balloon angioplasty). Follow-up was for 2 years.
Results
Primary patency and limb salvage after 1 and 6 months were statistically
insignificant in both groups (P=0.21 and 0.19 and 0.049 and 0.051,
respectively), but after 12 and 24 months, primary patency and limb salvage
were statistically highly significant in group A (P=0.0018 and 0.0011 and 0.0019
and 0.0023, respectively).
Conclusion
ET with DCB has equal risks but higher antirestenotic efficacy than plain old balloon
angioplasty in femoropopliteal artery disease. The use of DCB increases patency
and limb salvage. Stenting still has a rising role in bail-out in the treatment of SFA
occlusive disease and is associated with better acute angiographic results.
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