A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial.
OBJECTIVE
This prospective randomized trial compared the Angio-Seal VIP with Perclose Proglide and to manual compression with respect to time to hemostasis and ambulation, patient satisfaction, and vascular complications following percutaneous coronary intervention (PCI).


BACKGROUND
The use of arterial closure devices for the reduction of vascular complications following PCI remains controversial. There have been no head to head trials comparing these most commonly used arterial closure devices following PCI.


METHODS
Two hundred patients undergoing PCI were randomized to manual compression, Perclose Proglide or Angio-Seal VIP. Ambulation was allowed 3 hr after Perclose Proglide or Angio-Seal VIP and 6 hr after compression.


RESULTS
There were 10 failures to deploy Perclose Proglide and none for Angio-Sealt (P < 0.01). Time to hemostasis was significantly shorter with Angio-Seal VIP compared with Perclose Proglide (5.3 vs. 46.8 min, P < 0.01). Time to ambulation was shorter with Angio-Seal VIP than with Perclose Proglide (261 vs. 334 min, P < 0.05) and the time to ambulation, as expected, was longest with compression (943 min, P < 0.01 vs. Angio-Seal VIP and Perclose Proglide). Delay in ambulation was higher with Perclose Proglide than with Angio-Seal VIP (18 vs. 9, P < 0.01). There was no significant difference in major vascular complications between groups. Compared with compression, patient discomfort was significantly improved with Angio-Seal (1.5 vs. 2.0, P < 0.01), but not with Perclose Proglide.


CONCLUSIONS
The Angio-Seal VIPtrade mark device has a high rate of deployment success, which is significantly better than that of Perclose Proglide. Angio-Seal VIP allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide and is associated with greater patient satisfaction compared with compression.
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002406:Catheterization, Peripheral; D004434:Early Ambulation; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D006488:Hemostasis, Surgical / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011312:Pressure; D011446:Prospective Studies; D011677:Punctures; D013537:Sutures; D013997:Time Factors