Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization

INTRODUCTION AND BACKGROUND

Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand has currently positioned itself as a viable and safe approach for procedures in interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that this approach method mainly reduces the occlusion rate of the proximal radial artery, among other advantages; however, we still do not have scientific evidence on the various hemostasis methods for this approach. Practice varies between centers and countries and hemostasis methods vary from an elastic compression bandage to the use of devices manufactured specifically for this approach such as the PreludeSYNC DISTAL or modification of devices manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we intend to analyze the efficacy and safety of two hemostasis methods in patients who require an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no clinical trial that compares these methods face to-face in relation to their efficacy and safety. Retrospective studies indicate that both methods are effective in reducing radial artery occlusion and are safe in reducing the bleeding/hematoma rate.

THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR band) in patients undergoing percutaneous coronary intervention.

STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and comparative.

SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will undergo distal radial percutaneous coronary intervention/angiography.