Protected carotid stenting in high-risk patients: results of the SpideRX arm of the carotid revascularization with ev3 arterial technology evolution trial

Journal of Interventional Cardiology
Robert D SafianCREATE SpideRX Trial Investigators

Abstract

A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted during the 3-month period from March to May 2005. Carotid artery stenting (CAS) was performed with the SpideRX™ Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration. The primary end-point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end-point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05). CAS with distal embolic protection using the SpideRX™ Embolic Protection System is a reasonable alternative for revascularization of some high-risk patients with severe carotid stenosis.

References

Aug 15, 1991·The New England Journal of Medicine·UNKNOWN North American Symptomatic Carotid Endarterectomy Trial CollaboratorsM Eliasziw
May 12, 2004·Lancet·A HallidayUNKNOWN MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group
Sep 3, 2004·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Robert D SafianFrank J Criado
Oct 8, 2004·The New England Journal of Medicine·Jay S YadavUNKNOWN Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators
Jun 20, 2006·Journal of the American College of Cardiology·Robert D SafianUNKNOWN CREATE Pivotal Trial Investigators
Oct 20, 2006·The New England Journal of Medicine·Jean-Louis MasUNKNOWN EVA-3S Investigators
Nov 30, 2007·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·William A GrayUNKNOWN CAPTURE Trial Collaborators
Apr 12, 2008·The New England Journal of Medicine·Hitinder S GurmUNKNOWN SAPPHIRE Investigators
Apr 17, 2008·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·L Nelson HopkinsDonald S Baim

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Citations

Nov 26, 2010·Current Cardiology Reports·Vincent V Truong, Alex Abou-Chebl
Oct 28, 2015·Journal of Vascular Surgery·Christopher J KwolekRichard P Cambria
Oct 22, 2013·Cardiovascular Revascularization Medicine : Including Molecular Interventions·Punnaiah C MarellaRichard R Heuser
Jul 13, 2013·Journal of Interventional Cardiology·Mohammed Salim Al-DamlujiCarlos Mena
May 31, 2012·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Dimitrios NikasBernhard Reimers
Aug 16, 2014·Journal of the American College of Cardiology·Christopher J White
Jun 19, 2016·Postgraduate Medical Journal·Michael G NannaCarlos Mena

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