Randomized controlled trial of sheaths in diagnostic neuroangiography

PURPOSE: To determine the value of arterial sheaths in diagnostic neuroangi ography in a randomized controlled trial. MATERIALS AND METHODS: A total of 842 patients (411 men, 431 women; mean ag e, 59.4 years; age range, 29.5-94.3 years) undergoing diagnostic neuroangio graphy were randomly assigned to groups in which a sheath was introduced im mediately after puncture of the femoral artery (sheath group) or in which a diagnostic catheter was introduced without a sheath (control group). Two h undred twenty-four (26.7%) of 839 patients were receiving anticoagulants im mediately prior to the procedure. RESULTS: Complications (mostly small hematomas of the groin) occurred in 10 6 (12.6%) of 842 patients, with no difference between groups (53 [12.6%] of 421 patients in both; P > .99). Ease of catheter manipulation was greater in the sheath group than in the control group. Incidence of bleeding at the femoral puncture site during the procedure was less in the sheath group (s even [1.7%] of 421 patients) versus the control group (150 [35.6%] of 421 p atients), with a P value less than .001. Because of bleeding, sheath insert ion was necessary in 165 (39.2%) of 421 patients in the control group. This crossover group also had a higher rate of local complications (28 [17.0%] of 165 patients) than the sheath and control groups. Serious complications, such as stroke (one [0.12%] of 842 patients) and transient ischemic attack s (five [0.60%] of 842 patients), occurred with equal frequency in both the sheath and control groups. CONCLUSION: Use of arterial sheaths lessens the incidence of intraprocedura l bleeding at the femoral puncture site and increases ease of catheter mani pulation without increasing the number of groin complications.