Are distal protection devices 'protective' during carotid angioplasty and stenting?

Background and Purpose- To evaluate the periprocedural outcome after carotid artery stenting with embolic brain protection (EBP+) versus without embolic brain protection (EBP-). Methods- We retrospectively reviewed data from a prospective nonrandomized database of 357 patients who underwent carotid artery stenting in the neuroradiology division of our institution from 1999 to 2009. One hundred five patients underwent angioplasty and stenting without distal protection, whereas 252 were treated with distal protection. Patients were analyzed according to their EBP status (+ or -) for the primary end points of perioperative stroke, death, or myocardial infarction. Results- Unprotected stenting was mostly performed in the early years of this study and this is reflected in significant baseline differences between the two groups. In our earlier experience, carotid artery stenting was used in patients with more significant comorbidities. Diabetes mellitus (P=0.04), previous coronary artery disease (P=0.02) and myocardial infarction (P=0.04), and symptomatic lesion (P=0.01) were significantly more common in the EBP- cohort. Despite these baseline differences, there were no significant differences in the primary end points (2% in the EBP+ group and 4.8% in the EBP-, P=0.15). The incidence of ipsilateral stroke in the EBP- and in the EBP+ group was 3.8% versus 0.8%, respectively (P=0.6). There were 2 perioperative deaths (1 in each group) and 4 myocardial infarctions (3 in the EBP+ arm and 1 in the EBP- arm, all non-Q infarcts; P=nonsignificant). Conclusions- In accordance with recent literature, this series cast doubts as to the real effectiveness of distal embolic protection devices in reducing periprocedural complications.