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 de veloped puncture-sealing device consisting of subcutaneous bovine coll agen application designed to facilitate local hemostasis after coronar y angioplasty. Background. The most common local hemostatic procedure after coronary angioplasty consists of heparin discontinuation and del ayed sheath removal followed by mechanical compression at the puncture site. Methods. Between December 1998 and February 1993, 124 patients undergoing coronary angioplasty with either a 6F guiding catheter foll owed by a heparin infusion for >12 h or a 7F or 8F guiding catheter wi th optional heparin infusion were prospectively randomized to either d elayed sheath removal followed by manual compression (n = 62) or sheat h removal immediately after angioplasty combined with bovine collagen application for puncture site closure (n = 62). Half of the collagen p lugs were delivered using measured and half using estimated skin-arter y distance. Clinical and duplex sonographic evaluations of the punctur e site were performed 24 h later. Results. No significant difference i n the incidence of local hematomas was observed. Major complications w ere false aneurysm, venous thrombosis and arterial occlusion. The inci dence of false aneurysm was the same in both groups (4 [7%] of 62). Ve nous thrombosis (2%) and arterial occlusion (2%) were each recorded in one patient, both in the collagen application group. Conclusions. She ath removal and collagen application with this new vascular hemostasis device used directly after coronary angioplasty are not superior to d elayed sheath removal after heparin discontinuation followed by mechan ical compression. Arterial collagen sealing with this device in its cu rrent form is associated with a small but worrisome risk of arterial o cclusion.