COLLAGEN APPLICATION VERSUS MANUAL COMPRESSION - A PROSPECTIVE RANDOMIZED TRIAL FOR ARTERIAL PUNCTURE SITE CLOSURE AFTER CORONARY ANGIOPLASTY

Objectives. This study evaluated the safety and efficacy of a newly developed puncture-sealing device consisting of subcutaneous bovine collagen application designed to facilitate local hemostasis after coronary angioplasty. Background. The most common local hemostatic procedure after coronary angioplasty consists of heparin discontinuation and delayed sheath removal followed by mechanical compression at the puncture site. Methods. Between December 1991 and February 1993, 124 patients undergoing coronary angioplasty with either a 6F guiding catheter followed by a heparin infusion for >12 h or a 7F or 8F guiding catheter with optional heparin infusion were prospectively randomized to either delayed sheath removal followed by manual compression (n = 62) or sheath removal immediately after angioplasty combined with bovine collagen application for puncture site closure (n = 62). Half of the collagen plugs were delivered using measured and half using estimated skin-artery distance. Clinical and duplex sonographic evaluations of the puncture site were performed 24 h later. Results. No significant difference in the incidence of local hematomas was observed. Major complications were false aneurysm, venous thrombosis and arterial occlusion. The incidence of false aneurysm was the same in both groups (4 [7%] of 62). Venous thrombosis (2%) and arterial occlusion (2%) were each recorded in one patient, both in the collagen application group. Conclusions. Sheath removal and collagen application with this new vascular hemostasis device used directly after coronary angioplasty are not superior to delayed sheath removal after heparin discontinuation followed by mechanical compression. Arterial collagen sealing with this device in its current form is associated with a small but worrisome risk of arterial occlusion.