BACKGROUND: The transradial route for coronary intervention has proven to be safe, effective, and widely applicable in different clinical situations. Several compressive hemostatic devices have been introduced that have shown to be safe and are effective in achieving hemostasis. METHODS:Seven hundred ninety patients were randomly assigned to receive either TR band or Radistop hemostatic compression devices after transradial coronary procedure. The outcome measures were patient tolerance of the device, local vascular complications, and the time taken to achieve hemostasis. RESULTS:The mean age was 62.88 years, and 74.2% of the patients were men. Patient age, height, weight, wrist circumference, body mass index, male sex, hypertension, diabetes, hypercholesterolemia, and smoking incidences were similar in both groups. There were significantly more patients reporting no discomfort in the TR band group compared to the Radistop group (77% vs. 61%; P = 0.0001). Patients in the Radistop group reported significantly more pain across all categories of severity and three patients in the Radistop group were crossed over to TR band because of severe discomfort. Oozing and ecchymosis were seen in about 16% of the patients. Local small hematoma and large hematoma were seen in 5.4% and 2.2% patients respectively, and similar in both groups. Radial artery occlusion at the time of discharge was seen in 9.2% of the patients though only 6.8% showed persistent occlusion at the time of follow-up. The time taken to achieve hemostasis was significantly longer in the TR Band group (5.32 ± 2.29 vs. 4.83 ± 2.23 hr; P = 0.004). There was significantly higher incidence of radial artery occlusion in patients with smaller wrist circumference, the patients who experienced radial artery spasm during the procedure, and patients with no heparin administration during the procedure. CONCLUSIONS: We have shown in a randomized comparison of Radistop and TR band that both devices are safe and effective as hemostatic compression devices following transradial procedures. However, more patients felt discomfort with the Radistop device and the time taken to achieve hemostasis was longer with TR band.
RCT Entities:
BACKGROUND: The transradial route for coronary intervention has proven to be safe, effective, and widely applicable in different clinical situations. Several compressive hemostatic devices have been introduced that have shown to be safe and are effective in achieving hemostasis. METHODS: Seven hundred ninety patients were randomly assigned to receive either TR band or Radistop hemostatic compression devices after transradial coronary procedure. The outcome measures were patient tolerance of the device, local vascular complications, and the time taken to achieve hemostasis. RESULTS: The mean age was 62.88 years, and 74.2% of the patients were men. Patient age, height, weight, wrist circumference, body mass index, male sex, hypertension, diabetes, hypercholesterolemia, and smoking incidences were similar in both groups. There were significantly more patients reporting no discomfort in the TR band group compared to the Radistop group (77% vs. 61%; P = 0.0001). Patients in the Radistop group reported significantly more pain across all categories of severity and three patients in the Radistop group were crossed over to TR band because of severe discomfort. Oozing and ecchymosis were seen in about 16% of the patients. Local small hematoma and large hematoma were seen in 5.4% and 2.2% patients respectively, and similar in both groups. Radial artery occlusion at the time of discharge was seen in 9.2% of the patients though only 6.8% showed persistent occlusion at the time of follow-up. The time taken to achieve hemostasis was significantly longer in the TR Band group (5.32 ± 2.29 vs. 4.83 ± 2.23 hr; P = 0.004). There was significantly higher incidence of radial artery occlusion in patients with smaller wrist circumference, the patients who experienced radial artery spasm during the procedure, and patients with no heparin administration during the procedure. CONCLUSIONS: We have shown in a randomized comparison of Radistop and TR band that both devices are safe and effective as hemostatic compression devices following transradial procedures. However, more patients felt discomfort with the Radistop device and the time taken to achieve hemostasis was longer with TR band.
Authors: Pedro Beraldo de Andrade; Luiz Alberto Piva E Mattos; Marden André Tebet; Fábio Salerno Rinaldi; Vinícius Cardozo Esteves; Ederlon Ferreira Nogueira; João Ítalo Dias França; Mônica Vieira Athanazio de Andrade; Robson Alves Barbosa; André Labrunie; Alexandre Antônio Cunha Abizaid; Amanda Guerra de Moraes Rego Sousa Journal: Trials Date: 2013-12-18 Impact factor: 2.279
Authors: Muhammad Rashid; Chun Shing Kwok; Samir Pancholy; Sanjay Chugh; Sasko A Kedev; Ivo Bernat; Karim Ratib; Adrian Large; Doug Fraser; James Nolan; Mamas A Mamas Journal: J Am Heart Assoc Date: 2016-01-25 Impact factor: 5.501
Authors: Louis-Xavier Barrette; Ansar Z Vance; Susan Shamimi-Noori; Gregory P Nadolski; Shilpa Reddy; Kathleen M Kratz; Jonas W Redmond; Timothy W I Clark Journal: Cardiovasc Intervent Radiol Date: 2020-02-10 Impact factor: 2.740