The efficacy and safety of angioseal(R) compared to conventional manual compression after transfemoral percutaneous coronary intervention

Kim, Yong Hoon; Gwon, Hyeon Cheol; Kim, Phil Ho; Ahn, Seok Jin; Yu, Cheol Woong; Choi, Jin Ho; Lee, Sang Chul; Kim, June Soo; Kim, Duk Kyung; Jun, Eun Seok; Lee, Sang Hoon; Hong, Kyung Pyo; Park, Jeong Euy; Seo, Jung Don

Abstract

BACKGROUND: Although the number and the quality of percutaneous coronary intervention have been recently increased dramatically, the vascular complication at puncture site is still the major cause of patients' morbidity. We evaluated the safety and efficacy of newly-developed collagen-based arterial closure device, angioseal(R) after transfemoral percuatenous coronary intervention.
METHODS
This study was designed as a prospective single center non-randomized comparative study. A total 200 patients undergoing transfemoral percutaneous coronary intervention were enrolled between April 2002 and May 2003. They were divided into two groups; angioseal(R) group (group A, n=100) and manual compression group (group B, n=100). The baseline clinical and angiographic characteristics were reviewed. The time to sit up, the time to ambulation, the duration of hospital stay, major and minor vascular puncture site complications were monitored. The patients were followed-up for 1 week after the procedure by telephone.
RESULTS
The baseline clinical characteristics, clinical diagnosis, cardiovascular risk factors, types of procedure, doses and numbers of anticoagulants were similar between two groups. The blood pressure and activated clotting time were also similar. The time to sit up (group A: 4.3 0.3 hours, group B: 13.7 0.8 hours, p=0.004) and the time to ambulation (group A: 6.8 0.5 hours, group B: 18.8 2.1 hours, p=0.013) were shorter in group A. No major vascular complications were noted. The incidence of hematoma and bleeding were not significantly different between two groups. The incidence of ecchymosis, however, was significantly lower in group A (group A: 12%, group B: 3%, p=0.001) The duration of hospital stay was similar between two groups. During 7 days of follow-up period, the incidence of hematoma was significantly lower in group A (p=0.004). Although the incidence of ecchymosis was not significantly different between two groups.
CONCLUSION
The angioseal(R) may be associated with earlier ambulation and less patients' morbidity with low incidence of local complication rate compared to manual compression after transfemoral percutaneous coronary intervention.