ABSTRACT
BACKGROUND: We planned a three arm randomized study to evaluate the safety and efficacy of a new blood stopper, Ankaferd blood stopper (ABS) along with short-time compression, compared to either short-time compression with conventional sterile gauzes (CSG) or with a TR band after transradial (TRA) procedures. METHODS: The Ankaferd blood stopper as a new strategy to avoid early complications. After transradial procedures (ABS transradial) trial is designed in a prospective, randomized, placebo-controlled fashion and registered with http://clinicaltrials.gov (NCT02982733). Six hundred and thirty patients were randomized into three arms in a 1:1:1 fashion corresponding to three different strategies of patent hemostasis techniques after diagnostic or interventional catheterization. RESULTS: One (0.49%) patient in the CSG group and one patient (0.48%) in the TR Band group developed RAO at the end of the hemostasis, compared with 0 (0%) in the ABS group. At 30 days follow-up none of the groups had any patients with RAO. As a secondary end-points the difference was not statistically significant regarding hematoma among the three groups (P = 0.70). Bleeding during deflation of the TR Band or removal of the elastic bandage occurred in 55 patients (26.96%) in the CSG group and in 56 (27.31%) patients in the TR Band group compared to 19 patients (9.40%) in the ABS group (P < 0.001). CONCLUSION: Ankaferd blood stopper is a promising device for use in patent hemostasis, with no evidence on RAO at short-term or long term and with reduced risk of re-bleeding at the end of hemostasis.
Subject(s)
Endotamponade/methods , Hemostatic Techniques , Intraoperative Complications/therapy , Percutaneous Coronary Intervention , Plant Extracts/therapeutic use , Radial Artery , Blood Loss, Surgical , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/methods , Female , Humans , Intraoperative Complications/etiology , Male , Middle Aged , Outcome Assessment, Health Care , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Phytotherapy/methods , Radial Artery/injuries , Radial Artery/surgeryABSTRACT
OBJECTIVE: To evaluate the effect and clinical value of auricular point sticking for the diagnosis and treatment of vasospasm and vagus reflex during radial artery puncture, including radial artery spasm (RAS) and coronary artery spasm (CAS). METHODS: A total of 480 patients were randomized into an observation group (224 cases) and a control group (256 cases). Percutaneous coronary intervention and usual care in perioperative period were used in the control group. Auricular point sticking was began to apply 12 h before percutaneous coronary intervention in the observation group at Jiaogan (AH6a), Shenmen (TF4), Pizhixia (AT4), Neifenmi (CO18), Xin (CO15), Shen (CO10), Shenshangxian (TG2p), 1 min a time every point, once every 2 h, 12 h before and after operation. The incidences of vasospasm and vagus reflex during piercing process were compared, and the usage ratios of vasoactive agent were recorded, including glyceryl trinitrate, dopamine and atropine injections. RESULTS: The incidence of angiospasm was 4.9% (11/224) in the observation group, which was lower than 13.3% (34/256) in the control group (P<0.01). The incidence of vagal reflex of the observation group was 7.1% (16/224), which was lower than 19.5% (50/256) of the control group (P<0.01). The usage ratios of glyceryl trinitrate, atropine and dopamine injections were 3.6% (8/224), 7.1% (16/224), 6.3% (14/224) respectively in the observation group, which were lower than 14.8% (38/256), 15.6% (40/256), 15.2% (39/256) in the control group (all P<0.01). . CONCLUSION: Auricular point sticking achieves effect for the diagnosis and treatment of vasospasm and vagus reflex during radial artery puncture.