Prospective, randomized study of external jugular vein patch versus XXXX patch during carotid endarterectomy: perioperative and long-term results.

@entity1 @entity64 @entity281 @entity439 @entity736 @entity850
OBJECTIVES: The purpose of this study was to evaluate the relative risks and advantages of using external jugular vein (EJV) patch, compared with @entity736 ( @entity736 ) patch, during carotid endarterectomy. The primary end point was the relevant neurologic complication rate (RNCR; fatal or disabling @entity64 ) at any time during follow-up. Secondary end points included @entity64 -free survival, 30-day and long-term mortality, recurrent @entity850 rate (> or =50%), occlusion, @entity281 , @entity439 formation, and other local complications. METHODS: The study, a prospective randomized clinical trial carried out at a single center, was divided into two 3-year phases: December 1996 to March 1999, when @entity1 were enrolled, and March 1999 to March 2002, which was the follow-up period. Inclusion criteria included an external jugular vein suitable for patching, defined as vein diameter 3 mm or larger and absence of collateral vessels noted on preoperative color duplex ultrasound scans. @entity1 were prospectively randomized 1:1 to receive either the EJV (n = 80; group A) or synthetic (n = 80; group B) patch. RESULTS: Carotid endarterectomy and patching was performed by one surgeon. At 30 months the RNCR-free rate, analyzed with the Kaplan-Meier method, was 98.7% for group A (1 ipsilateral @entity64 ) and 94.6% for group B (4 ipsilateral disabling @entity64 ), and remained stable to 60 months. No statistical difference was observed with the log-rank test. @entity64 -free survival rate was 100% for group A and 98.7% for group B at 1 year, 98.7% for group A and 93.6% for group B (1 ipsilateral @entity64 ) at 30 months, and was unchanged at 60 months. Life table analysis demonstrated freedom from significant recurrent @entity850 (> or =50%) of 97.5% for both groups at 6 months, 93.6% for group A and 92.2% for group B at 30 months, and 90.2% for group A and 86.7% for group B at 60 months. No statistical difference was observed with the log-rank test. In no @entity1 was recurrent @entity850 greater than 70%. No @entity439 formation was noted during follow-up. CONCLUSIONS: We can conclude, with the power limitation of the study, that carotid endarterectomy can be safely performed with either the EJV or @entity736 patch. Advantages of the EJV for carotid angioplasty include no cost for material, low risk for graft infection, and preservation of the saphenous vein.
