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Published on: September 20, 2020
A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary
Sudhir Rathore1, Rodney H Stables, Maheshwar Pauriah
1Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool L14 3PE, UK. sudhirrathore@hotmail.com
Insights
The TR band offers better patient comfort than the Radistop device after transradial coronary procedures. However, Radistop achieves hemostasis faster, with both devices proving safe and effective for managing bleeding.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Transradial access is a safe and effective approach for coronary interventions.
- Various hemostatic devices exist to manage bleeding after transradial procedures.
Purpose of the Study:
- To compare patient tolerance, local vascular complications, and hemostasis time between TR band and Radistop devices.
- To evaluate the safety and efficacy of two hemostatic compression devices post-transradial coronary procedures.
Main Methods:
- A randomized trial involving 790 patients undergoing transradial coronary procedures.
- Patients were assigned to either TR band or Radistop for hemostasis.
- Outcomes included patient-reported discomfort, vascular complications, and time to hemostasis.
Main Results:
- TR band showed significantly higher patient comfort (77% vs. 61% reporting no discomfort).
- Radistop group experienced more pain, with three patients switching to TR band due to severe discomfort.
- No significant differences in oozing, ecchymosis, or hematoma formation were observed between groups.
- Radial artery occlusion occurred in 9.2% at discharge, persisting in 6.8% at follow-up.
- TR band required a significantly longer time to achieve hemostasis (5.32 vs. 4.83 hours).
- Higher radial artery occlusion rates were linked to smaller wrist circumference, radial artery spasm, and lack of heparin administration.
Conclusions:
- Both TR band and Radistop are safe and effective hemostatic devices after transradial procedures.
- TR band provides superior patient comfort compared to Radistop.
- Radistop achieves hemostasis more quickly than TR band.
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. © 2010 Wiley-Liss, Inc.
