Restricted accessResearch articleFirst published online 2013-12
Treatment of Chronic SFA In-Stent Occlusion With Combined Laser Atherectomy and Drug-Eluting Balloon Angioplasty in Patients With Critical Limb Ischemia: A Single-Center,Prospective,Randomized Study
Purpose: To compare the safety and efficacy of
laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment
with DEB angioplasty alone in patients affected by critical limb ischemia (CLI)
and superficial femoral artery (SFA) chronic stent occlusion in a prospective,
randomized study.
Methods: Among 448 CLI patients treated from
December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8
years) with chronic SFA in-stent occlusion were randomly assigned to treatment
using LD+DEB (n=24) or DEB angioplasty alone (n=24).
Patency at 12 months was the primary outcome measure; secondary outcomes were
target lesion revascularization (TLR) and clinical success at 12 months.
Results: In the LD+DEB group, the patency
rates at 6 and 12 months (91.7% and 66.7%, respectively) were
significantly higher (p=0.01) than in the DEB only patients (58.3%
and 37.5%, respectively). TLR at 12 months was 16.7% in the
LD+DEB group and 50% in the DEB only group (p=0.01). Two
(8%) patients needed major amputations in the LD+DEB group vs. 11
(46%) in the DEB only group at 12 months (p=0.003).
Conclusion: In this small initial experience,
combined treatment with LD and DEB angioplasty is correlated with better
outcomes in CLI patients with occluded SFA stents.
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