A MULTICENTER RANDOMIZED TRIAL COMPARING A PERCUTANEOUS COLLAGEN HEMOSTASIS DEVICE WITH CONVENTIONAL MANUAL COMPRESSION AFTER DIAGNOSTIC ANGIOGRAPHY AND ANGIOPLASTY

Objectives. A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheteriza tion and angioplasty. Background. peripheral vascular complications af ter diagnostic catheterization or more complex interventional procedur es, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. Methods. A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. Results. After d iagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compress ion (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angiop lasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving he parin], 33.6 +/- 24.2 min [n = 134 control patients not receiving hepa rin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheteriz ation in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/ - 17.8 h, p < 0.05). It was also less in patients who underwent angiop lasty when the device was used after discontinuation of anticoagulatio n (23.0 +/- 11.1 h, withoutheparin), as compared with control compress ion techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was e ven shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the devi ce was placed immediately after angioplasty while they were still full y anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after d iagnostic catheterization and a low incidence of major complications i n patients who underwent angioplasty (0.7% in control patients, 1.4% w ith the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in contro l patients, p = 0.14). Conclusions. A new vascular hemostasis device c an significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing compl ications, length of hospital stay and cost remains to he determined.