Flow Reversal Versus Filter Protection

Abstract

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.

Operator’s Experience Is the Most Efficient Embolic Protection Device for Carotid Artery Stenting

“…At the end of our discussion, we have to conclude that de Castro-Afonso et al 6 presented interesting data and reminded us that it is still not clear at all which kind of EPD can provide the best cerebral protection. Looking at their data, operator's experience seems still to be the best protective factor for the brain of a patient undergoing CAS.…”

“…Montorsi et al 7 and Bijuklic et al 8 adopted the endovascular clamping system in their studies for proximal protection, contrarily de Castro-Afonso et al used the flowreversal system. 6 If this difference can justify the disconcerting difference in the results is hard to tell, we could speculate that the endovascular clamping system is smaller and more flexible than the flow reversal one. Consequently it should be less traumatic when it is removed from the carotid artery at the end of the procedure when neuroprotection is not in place any more.…”

“…In this issue of Circulation: Cardiovascular Interventions, de Castro-Afonso et al 6 reported the results of a single center trial in which the authors evaluated the relative efficacy of proximal (n=21) and distal EPD (n=19) for CAS. They reported a significant reduction in the incidence ( A subcohort analysis from a randomized trial (n=53) that compared proximal versus distal EPD for the treatment of lipid-rich carotid stenosis showed robust reduction in the occurrence of new DW-MRI brain lesions when proximal protection was used (42.8% [9/21] rate in the distal EPD group and 14.3% [2/14] in the proximal EPD).…”

“…In this study by de Castro-Afonso et al, 6 the investigator adopted a stainless steel stent with a closed cell design, similarly the same stent was used by Montorsi et al 7 in their study. Concerning the specific EPD, it is true that all the studies compared distal with proximal EPDs, but there are some differences among them.…”

“…11,12 Both the European studies are coming from catheterization laboratories with robust experience in carotid stenting performed with both proximal and distal EPDs. de Castro-Afonso et al 6 stated that they do have a good experience in distal protected CAS (450 CAS procedures in 10 years). This means ≈50 procedures per year, a number that is in accordance with current guidelines and should provide outcomes similar to those of high volume centers with well-experienced operators.…”