[Efficacy of hemostatic puncture closing device for hemostasis and early ambulation after coronary angiography and angioplasty: results of a multicenter trial].

To assess the efficacy and safety of a hemostatic puncture closing device for reducing patient immobilization after cardiac catheterization from a percutaneous femoral artery approach, we conducted a prospective, randomized trial at 4 participating centers. A total of 240 patients (183 men, 57 women, mean age 61 +/- 10 yr; 157 patients underwent diagnostic angiography, 83 patients underwent coronary angioplasty) were randomized to either the device group (n = 120) or the manual compression group (n = 120). There were no statistical differences in age, gender, weight or sheath size between the 2 groups. A 7, 8F sheath was used in 53 patients of the device group and in 43 patients of the manual compression group. One hundred and two patients (85%) in the device group and 96 patients (80%) in the manual compression group received heparin. Protamine was used in one patient of the device group and 23 patients of the manual compression group. Activated clotting time just prior to sheath removal was 206 +/- 64 sec in the device group and 170 +/- 47 sec in the manual compression group (p < 0.01). Successful placement of the device was achieved in 118 of 120 patients (98%). Time to hemostasis was significantly shorter in the device group (0.8 +/- 3.2 vs 12.2 +/- 5.3 min, p < 0.01). Time to ambulation could be reduced in the device group (5.3 +/- 3.7 vs 10.9 +/- 5.1 hr, p < 0.01). The following complication rates occurred in the device group as compared with the manual compression group: hematoma, 16% vs 10%; bleeding, 8% vs 3%; pseudoaneurysm, 0% vs 1%, respectively. None of these differences was statistically significant. These results indicate that early ambulation using a hemostatic puncture closing device is feasible without significantly increasing the risk of peripheral vascular complications.

RCT Entities:   Population Interventions Outcomes