Carotid artery stenosis

Qureshi and colleagues report the results of a prospective longitudinal pilot registry to test the short-term (30-day) and intermediate-term (1-year) safety and efficacy of a novel coiled sheet stent used for extracranial carotid artery (CA) angioplasty and stent placement. The major advantage of this new stent, compared with current stent designs, apparently lies in its improved flexibility and maneuverability. Treatment was attempted in 45 patients who had high-grade internal CA stenosis (� 70% according to North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) with or without symptoms; the patient cohort had multiple medical comorbidities that are usually associated with CA stenosis. The primary outcome was a technically successful stent placement that produced less than 30% stenosis on angiograms with no incidence of mortality or ipsilateral stroke within 30 days. Most patients (35 of 45) were observed for 1 year for ipsilateral stroke and recurrent stenosis (� 70%) by using Doppler ultrasonography. Effective delivery of the stent was achieved in 44 of 45 patients. It is not clear why the one patient in whom the authors were unable to pass a guidewire for stent delivery was not included as an example of primary outcome treatment failure in the intent-to-treat analysis. Inclusion of this patient would change the primary outcome measure from 93 to 91%. Among the 44 patients who underwent stent placement, within 30 days there were two ipsilateral strokes (4.5%), two transient ischemic attacks (4.5%), and two deaths (4.5%), one of which occurred in a patient who suffered a stroke. These stroke rates are comparable to those previously reported by Roubin, et al., 7 in a prospective longitudinal registry of CA angioplasty and stent placement, in which the 30-day stroke and death rate was 7.4%. The rates are also comparable to those of a larger retrospective analysis, 8 in which the 30-day stroke and death rate was reported to be 5.1%. In the current study, although primary outcome was restricted to ipsilateral stroke, an additional vertebrobasilar stroke occurred within 30 days. Thus, the total 30day incidence of cerebral ischemia in patients who received the stent was 11.3% (strokes 6.8%, transient ischemic attacks 4.5%). Distal protection devices were not used in the current study. Presumably, their use would lower the incidence of cerebral ischemia, although direct proof of this is lacking.