AIMS: AngioSeal and StarClose are vascular closure devices (VCDs) that can be used following cardiac catheterisation via the femoral artery to achieve haemostasis. Both devices have been demonstrated to be superior to conventional manual pressure, which reduce time to haemostasis and time to patient ambulation. We sought to compare these devices in a prospective, randomised trial. METHODS:Patients undergoing elective coronary angiography were randomised to receive either AngioSeal VIP or StarClose VCD with immediate postprocedure mobilisation. Bruising was recorded at 30 min, 60 min and at 1 week postprocedure. Patient satisfaction surveys were taken at 1 h and 1 week postprocedure. Complications for both groups were compared. RESULTS:Four hundred and one patients were included. Arteriotomy closure was achieved in 144 of 208 (69.2%) patients randomised to AngioSeal and 134 of 193 (69.3%) patients randomised to StarClose (p = ns). There was no significant bruising in either group at either 30 or 60 min postprocedure. However, at 1 week, there was significantly more bruising in the AngioSeal group than the StarClose group (63.1 vs. 38.5cm2, p = 0.02). Patient satisfaction and pain perception with the procedure at closure were not significantly different between the groups. Deployment success and instant mobilisation rates were significantly lower for junior, as compared with senior, operators. CONCLUSION: Achievement of haemostasis is similar with both AngioSeal and StarClose. The StarClose vascular closure device results in significantly less bruising at 1 week postprocedure as compared with AngioSeal, with no significant differences in complication rates. Patients' pain perception and satisfaction are similar with both VCDs.
RCT Entities:
AIMS: AngioSeal and StarClose are vascular closure devices (VCDs) that can be used following cardiac catheterisation via the femoral artery to achieve haemostasis. Both devices have been demonstrated to be superior to conventional manual pressure, which reduce time to haemostasis and time to patient ambulation. We sought to compare these devices in a prospective, randomised trial. METHODS:Patients undergoing elective coronary angiography were randomised to receive either AngioSeal VIP or StarClose VCD with immediate postprocedure mobilisation. Bruising was recorded at 30 min, 60 min and at 1 week postprocedure. Patient satisfaction surveys were taken at 1 h and 1 week postprocedure. Complications for both groups were compared. RESULTS: Four hundred and one patients were included. Arteriotomy closure was achieved in 144 of 208 (69.2%) patients randomised to AngioSeal and 134 of 193 (69.3%) patients randomised to StarClose (p = ns). There was no significant bruising in either group at either 30 or 60 min postprocedure. However, at 1 week, there was significantly more bruising in the AngioSeal group than the StarClose group (63.1 vs. 38.5cm2, p = 0.02). Patient satisfaction and pain perception with the procedure at closure were not significantly different between the groups. Deployment success and instant mobilisation rates were significantly lower for junior, as compared with senior, operators. CONCLUSION: Achievement of haemostasis is similar with both AngioSeal and StarClose. The StarClose vascular closure device results in significantly less bruising at 1 week postprocedure as compared with AngioSeal, with no significant differences in complication rates. Patients' pain perception and satisfaction are similar with both VCDs.
Authors: Venkatesan D Vidi; Michael E Matheny; Usha S Govindarajulu; Sharon-Lise T Normand; Susan L Robbins; Vikram V Agarwal; Sripal Bangalore; Frederic S Resnic Journal: JACC Cardiovasc Interv Date: 2012-08 Impact factor: 11.195