Clinical trials for stenting: CAVATAS, SAPPHIRE

CAVATAS carotid and vertebral artery transluminal angioplasty study-- large prospective randomized trial oo CEA v. carotid angioplasty. Criteria-- symptommtic stenosis > 70 %. Surgical candidates were randomized to angioplasty or stent. Nonsurgical candidates were randomized to angioplasty v. best medical treatment. In first group, 504 patients were randomized and the differences were nonexistent. In both the surgical and angioplasty group, the rate of any stroke lasting more than a week or death in first 30 days was 10 % The rate of disabling stroke or death in first 30 days was 6 % for each. The rate of restenosis was twice as great in the endovascular cohort v. the surgical group, 18 v. 9 %.

SAPHIRE-- stenting and angioplasty with protection in patients at high risk for endarterectomy-- compared stenting with protection v. CEA in surgically high risk patients with comorbidities. Enrolled 747 patients with > 50 % symptomatic stenosis or > 80 % asymptomatic stenosis. Stenting with a dis: tal protection device was not inferior and narrowly missed superiority. The risk of stroke, death oo MI was 39 % lower with stenting at 30 days. The risk of ipsilateral stroke was 7.9 % lower at one year. Critiques: 1) a high number, 55 % were excluded due to "surgical risk." 2) 20 % had restenosis after prior CEA 3) Inclusion of MIi as an endpoint obscures cerebrovascular data.

Ongoing trials:
EVA 3S Endarterectomy v. angioplasty in severe carotid stenosis
ARCHeR-2 (Acculink)
ICSS= CAVATAS 2 compares stent v. CEA in high risk group
SPACE -Stent protected percutaneous angioplasty of the carotid v endarterectomy 1900 patients, German study
CREST