The efficacy and safety of angioseal(R) compared to conventional manual compression after transfemoral percutaneous coronary intervention.
- Author:
Yong Hoon KIM
1
;
Hyeon Cheol GWON
;
Phil Ho KIM
;
Seok Jin AHN
;
Cheol Woong YU
;
Jin Ho CHOI
;
Sang Chul LEE
;
June Soo KIM
;
Duk Kyung KIM
;
Eun Seok JUN
;
Sang Hoon LEE
;
Kyung Pyo HONG
;
Jeong Euy PARK
;
Jung Don SEO
Author Information
1. Division of Cardiology, Cardiac and Vascular Center, Samsung Medical Center, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea. hcgwon@smc.samsung.co.kr
- Publication Type:Comparative Study ; Original Article
- Keywords:
Device;
Hemostasis;
Femoral artery;
Percutaneous transluminal coronary angioplasty
- MeSH:
Angioplasty, Balloon, Coronary;
Anticoagulants;
Blood Pressure;
Diagnosis;
Ecchymosis;
Femoral Artery;
Follow-Up Studies;
Hematoma;
Hemorrhage;
Hemostasis;
Humans;
Incidence;
Length of Stay;
Percutaneous Coronary Intervention*;
Prospective Studies;
Punctures;
Risk Factors;
Telephone;
Walking
- From:Korean Journal of Medicine
2004;66(5):496-503
- CountryRepublic of Korea
- Language:Korean
-
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.
