Prospective Randomized Trial of Carotid Endarterectomy Contralateral to Carotid Artery Occlusion

Completed

Phase N/A Results

Results

The incidence of perioperative cerebrovascular accidents (CVAs) was 4.4% for PC, 0.8% for PTFE-PC, and 0% for vein patch closure (PC vs vein patch, p = 0.0165; PC vs all patching [vein and PTFE], p = 0.007). The perioperative CVA and reversible ischemic neurologic deficit (RIND) combined rates for all patching were superior to PC (1.5% vs 5.2%; p = 0.04). These combined rates were also superior for vein patch closure when compared with PC (0.8% vs 5.2%; p = 0.037). After 1 month of follow-up, 11.9% of the PC arteries were narrowed 50% or more in contrast to 2.3% for PTFE-PC, 3.1% for SVP, and 10.3% for JVP. Group A had a higher incidence of contralateral transient ischemic attacks (TIAs) (12.2% versus 0.9%; P<0.0001), contralateral strokes (2% versus 0%; P=0.025), and combined contralateral TIAs/strokes (14.3% versus 0.9%; P<0.0001). The rates for perioperative and all strokes (operative and late) were 2% and 4.1% (2% ipsilateral and 2% contralateral strokes) for group A and 2.9% and 3.4% (all ipsilateral) for group B (P=0.60 and 0.85, respectively). The rates for perioperative and all TIAs were 0% and 14.3% for group A versus 2.6% and 6.3% for group B (P=0.918 and P=0.08, respectively). The rates for perioperative and all neurological events (TIA and stroke) were 2% and 18.4% for group A and 5.4% and 9.7% for group B (P=0.27 and 0.113, respectively). The cumulative stroke-free survival rates at 5 years were 84% for group A and 77% for group B (P>0.1). The perioperative and late deaths were similar for both groups (group A, 8%; group B, 14%). The overall stroke or death rates for symptomatic patients in groups A and B were also similar.