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 VIPTM with Perclose Proglide(TM) 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(TM) or Angio-Seal VIPTM. Ambulation was allowed 3 hr after Perclose Proglide(TM) or Angio-Seal VIPTM and 6 hr after compression. Results: There were 10 failures to deploy Perclose Proglide(TM) and none for Angio-Seal(TM) (p < 0.01). Time to hemostasis was significantly shorter with Angio-Seal VIPTM compared with Perclose Proglide(TM) (5.3 vs. 46.8 min, P < 0.01). Time to ambulation was shorter with Angio-Seal VIPTM than with Perclose ProglideTM (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 VIPTM and Perclose Proglide(TM)). Delay in ambulation was higher with Perclose Proglide(TM) than with Angio-Seal VIPTM (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(TM) (1.5 vs. 2.0, P < 0.01), but not with Perclose Proglide(TM). Conclusion: The Angio-Seal VIPTM device has a high rate of deployment success, which is significantly better than that of Perclose Proglide(TM). Angio-seal VIPTM allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide(TM) and is associated with greater patient satisfaction compared with compression. (c) 2008 Wiley-Liss, Inc.