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Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study.

Abstract：

PURPOSE:Outcome with selective or systematic stenting with the Palmaz vascular stent was compared in patients with limb-threatening ischemia or persistent disabling claudication despite medical therapy, with less than 7 cm stenosis or occlusion of the superficial femoral artery. METHODS:This was a multicenter prospective randomized trial with centralized allocation of treatment and independent review of vascular events. The primary end point was presence of more than 50% stenosis at 1-year angiographic follow-up. Secondary end points were survival; occurrence of vascular events in the treated leg; and number of failed procedures, defined as more than 50% stenosis or death at 1 year. RESULTS:Two hundred twenty-seven patients were enrolled in the study, 112 in the selective stent group, and 115 in the systematic stent group. Seventeen patients (15%) in the selective stent group received a stent after suboptimal results of percutaneous transluminal angioplasty. Angiograms for 140 patients were available at 1-year follow-up and demonstrated no statistical difference between the two groups; more than 50% stenosis of the dilated site was noted in 21 of 65 patients (32,3%) in the selective stent group and 26 of 75 patients (34.7%) in the systematic stent group (P =.85, Fisher exact test). Survival in the percutaneous transluminal angioplasty and stent groups was, respectively, 92% and 96% at 1 year, 89% and 93% at 2 years, and 82% and 80% at 4 years (P =.40, log-rank test). Survival free of new vascular events in the treated limb was 77% and 65% at 1 year, 70% and 53% at 2 years, and 57% and 44% at 4 years (P =.017, log-rank test). Number of failed procedures at 1 year was 29 of 86 (33%) and 30 of 89 (34%) (P = 0.9). CONCLUSION:Systematic stenting of short stenosis or occlusion of the superficial femoral artery is not justified. Palmaz vascular stent placement should be reserved for use in patients with suboptimal results of balloon angioplasty.

journal_name

J Vasc Surg

journal_title

Journal of vascular surgery

authors

Becquemin JP,Favre JP,Marzelle J,Nemoz C,Corsin C,Leizorovicz A

doi

10.1067/mva.2003.155

subject

Has Abstract

pub_date

2003-03-01 00:00:00

pages

487-94

issue

eissn

0741-5214

issn

1097-6809

pii

S0741521402752968

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study.