BACKGROUND:Carotid artery stenting (CAS) has become an alternative treatment for patients presenting symptomatic carotid artery stenosis. The improvement in clinical outcomes with CAS has been associated with the development of embolic protection devices. The trial aim is to compare flow reversal versus filter protection during CAS through femoral access. METHODS AND RESULTS: Patients were randomly enrolled in CAS using flow reversal or filter protection. The primary end points were the incidence, number, and size of new ischemic brain lesions after CAS. The secondary end points included major adverse cardiac and cerebrovascular events, transient ischemic attack, and definitive ischemic brain lesions on fluid-attenuated inversion recovery magnetic resonance image at a 3-month follow-up. Ischemic brain lesions were assessed by a 3T magnetic resonance image. Neurological outcomes were evaluated by means of the National Institutes of Health Stroke Scale and the modified Rankin Scale (mRS). Forty consecutive patients were randomly assigned. Compared with flow reversal (n=21), filter protection (n=19) resulted in a significant reduction in the incidence (15.8% versus 47.6%, P=0.03), number (0.73 versus 2.6, P=0.05), and size (0.81 versus 2.23 mm, P=0.05) of new ischemic brain lesions. Two patients, 1 from each group, presented transient ischemic attack at 3-month follow-up. There were no major adverse cardiac and cerebrovascular events in the hospital or at 3-month follow-up. CONCLUSIONS: In this small sample size trial, filter protection was more effective than flow reversal in reducing ischemic brain lesions during CAS through femoral approach. CLINICAL TRIAL REGISTRATION URL: http://portal2.saude.gov.br/sisnep/. Unique identifier: 0538.0.004.000-10.
RCT Entities:
BACKGROUND: Carotid artery stenting (CAS) has become an alternative treatment for patients presenting symptomatic carotid artery stenosis. The improvement in clinical outcomes with CAS has been associated with the development of embolic protection devices. The trial aim is to compare flow reversal versus filter protection during CAS through femoral access. METHODS AND RESULTS:Patients were randomly enrolled in CAS using flow reversal or filter protection. The primary end points were the incidence, number, and size of new ischemic brain lesions after CAS. The secondary end points included major adverse cardiac and cerebrovascular events, transient ischemic attack, and definitive ischemic brain lesions on fluid-attenuated inversion recovery magnetic resonance image at a 3-month follow-up. Ischemic brain lesions were assessed by a 3T magnetic resonance image. Neurological outcomes were evaluated by means of the National Institutes of Health Stroke Scale and the modified Rankin Scale (mRS). Forty consecutive patients were randomly assigned. Compared with flow reversal (n=21), filter protection (n=19) resulted in a significant reduction in the incidence (15.8% versus 47.6%, P=0.03), number (0.73 versus 2.6, P=0.05), and size (0.81 versus 2.23 mm, P=0.05) of new ischemic brain lesions. Two patients, 1 from each group, presented transient ischemic attack at 3-month follow-up. There were no major adverse cardiac and cerebrovascular events in the hospital or at 3-month follow-up. CONCLUSIONS: In this small sample size trial, filter protection was more effective than flow reversal in reducing ischemic brain lesions during CAS through femoral approach. CLINICAL TRIAL REGISTRATION URL: http://portal2.saude.gov.br/sisnep/. Unique identifier: 0538.0.004.000-10.
Authors: Mandy D Müller; Stefanie von Felten; Ale Algra; Jean-Pierre Becquemin; Richard Bulbulia; David Calvet; Hans-Henning Eckstein; Gustav Fraedrich; Alison Halliday; Jeroen Hendrikse; George Howard; John Gregson; Olav Jansen; Martin M Brown; Jean-Louis Mas; Thomas G Brott; Peter A Ringleb; Leo H Bonati Journal: Circ Cardiovasc Interv Date: 2019-08-05 Impact factor: 6.546
Authors: Leo H Bonati; Joanna Dobson; Roland L Featherstone; Jörg Ederle; H Bart van der Worp; Gert J de Borst; Willem P Th M Mali; Jonathan D Beard; Trevor Cleveland; Stefan T Engelter; Philippe A Lyrer; Gary A Ford; Paul J Dorman; Martin M Brown Journal: Lancet Date: 2014-10-14 Impact factor: 79.321
Authors: D Doig; B M Hobson; M Müller; H R Jäger; R L Featherstone; M M Brown; L H Bonati; T Richards Journal: Eur J Vasc Endovasc Surg Date: 2015-10-21 Impact factor: 7.069