Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial.

BACKGROUND

Radial artery occlusion (RAO) occurs after transradial access (TRA), limiting future ipsilateral access. Pragmatic RAO-lowering strategies need to be developed.

METHODS

Patients undergoing transradial cardiac catheterization were randomized to receive postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression (group 2). Hemostatic compression was performed for 120 minutes. Patients in group 2 received ipsilateral ulnar artery compression for the first 60 minutes of radial hemostasis. The primary endpoint of the study was achievement of patent hemostasis, defined as radial artery patency at 15 minutes after onset of hemostatic compression. Radial artery patency was measured at 15 minutes, 60 minutes, 90 minutes, and 120 minutes after onset of compression and 1 hour after removal of the compression bands.

RESULTS

A total of 253 patients were randomized (127 in group 1 and 126 in group 2). Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001). RAO at 1 hour post band removal was significantly lower in group 2 vs group 1 (1.6% vs 10.2%, respectively; P<.001). Rebound bleeding occurred less frequently in group 2 vs group 1 (1.6% vs 7.9%, respectively; P=.03).

CONCLUSION

Ipsilateral ulnar compression performed for the initial 1 hour during the radial hemostatic process after TRA using a dedicated double-balloon device is associated with higher rates of patent hemostasis and lower incidence of RAO compared with a single-balloon band.