The study sought to evaluate the benefit of the reduction in intensity and duration of the hemostasis obtained with the transradial (TR) Band compression device on the radial artery occlusion (RAO) rate. RAO is the most frequent complication of TR access for cardiac catheterization and limits future use of this safe route. Its occurrence must be minimized. Between 2009 and 2016, 3,616 TR accesses were randomized to TR Band hemostasis during 3 consecutive protocols: CRASOC I (Compression of Radial ArterieS without Occlusion): 13 versus 10 cc of air into the TR Band and for 4 hours of continuous compression; CRASOC II: 10 cc of air for 3 hours versus 2 hours of compression; and CRASOC III: 10 cc of air for 2 hours versus 1.5 hours of compression and virtual 4F introducer as default sheath (both arms). Radial artery patency was assessed by plethysmography at 24 hours, using Doppler for doubtful or negative plethysmography. The primary end point, 24 hours of RAO, was markedly reduced when hemostasis was soft (10 cc of air) and short (1.5 hours) and resulted in a 2.3% rate of RAO versus 9.4% for 13 cc, 4 hours. Hemostasis was obtained in 89% of patients with only 10 cc of air and in 97% of patients with less than the recommended 13 cc. About 8% of patients required more than the 1.5 hours of hemostasis time. In conclusion, short and soft hemostasis with the TR Band device leads to a low RAO rate.
2017 May 10. pii: S0002-9149(17)30772-5.