Randomized controlled trial of topical hemostasis pad use for achieving vascular hemostasis following percutaneous coronary intervention.

OBJECTIVES: We conducted a randomized trial to determine the efficacy of two topical hemostasis pads in promoting vascular hemostasis following PCI, and to assess the appropriate level of anticoagulation for sheath removal.

BACKGROUND: Pads coated with procoagulant materials are widely marketed and used to augment vascular hemostasis following PCI, yet clinical effectiveness and safety data are lacking.

METHODS: 184 patients who underwent PCI using the femoral approach were randomized to one of four methods of sheath removal: (1) at ACT < 250 using the Chito-Seal pad; (2) at ACT < 250 using the Clo-Sur PAD; (3) at ACT < 250 using manual compression alone; (4) at ACT < 170 using manual compression alone.

RESULTS: Time to hemostasis was significantly shorter in the hemostasis pad groups compared to the conventional compression groups (16.2 +/- 4.9, 16.0 +/- 5.3, 19.3 +/- 7.8, and 18.3 +/- 5.7 min, respectively, P = 0.027), however overall bed rest times following intervention were not reduced by use of either hemostasis pad. The incidence of major or minor bleeding complications did not differ among groups. Irrespective of hemostasis pad use, removal of sheaths at higher ACT levels allowed shorter time to ambulation following PCI without an increase in bleeding events.

CONCLUSIONS: The hemostasis pads tested shortened time to hemostasis compared to standard manual compression, although the absolute reduction in time to hemostasis was relatively small and did not translate into a reduction in overall bed rest time. Independent of hemostasis pad use, removal of arterial sheaths at higher than conventional activated clotting times was safe and resulted in significant reductions in time to ambulation.