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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
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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
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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
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Journal Article
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
2013
Overview
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.
Publisher
SAGE Publications,Allen Press Inc
Subject
/ Angioplasty, Balloon - adverse effects
/ Angioplasty, Balloon - instrumentation
/ Angioplasty, Balloon - mortality
/ Atherectomy - adverse effects
/ Atherectomy - instrumentation
/ Coated Materials, Biocompatible
/ Female
/ Femoral Artery - diagnostic imaging
/ Femoral Artery - physiopathology
/ Humans
/ Ischemia
/ Lasers
/ Male
/ Patients
/ Peripheral Arterial Disease - diagnosis
/ Peripheral Arterial Disease - mortality
/ Peripheral Arterial Disease - physiopathology
/ Peripheral Arterial Disease - therapy
/ Rome
/ Stents
/ Studies
