Objective: Novel hemostasis strategies, including PreludeSYNC DISTAL, Merit Medical Systems, Inc. South Jordan, UT, USA (PSD) radial compression device for distal radial artery (DRA) access, have been described for radial access protocols. This study aimed to compare the safety profile of PSD and Terumo radial (TR) Band®.
Methods: This prospective interventional study was conducted on patients who underwent coronary interventions via either the DRA or forearm radial artery (FRA). Patients with an arterial diameter of <2 mm, requiring dialysis, with unstable acute coronary syndrome, failed radial cannulation, and sheath insertion were excluded. PSD and TR Band® were used for hemostasis after DRA and FRA access, respectively. The time to hemostasis and complications, including minor/major hematoma, radial artery occlusion (RAO), and neurological symptoms (after 20 days) were recorded. The mean and standard deviation were calculated for age and hemostasis duration. Frequency and percentages were calculated for categorical variables. Independent t-test and Chi-squared test were performed to determine the significance of the differences between the two groups. A p-value of <0.05 was significant.
Results: Of 139 participants, TR Band® and PSD were used in 76 and 63 patients, respectively. The mean age of the participants was 58.70±10.00 years, and the majority of the patients were men (67.60%). The hemostasis time of both devices was similar (p>0.490). Compared with PSD, TR Band® had more complications (52.63% vs. 23.81%; p=0.020), particularly RAO [odds ratio (OR), 3.17; p=0.018] and neurological problems (OR, 5.33; p=0.005).
Conclusions: Although, PSD seems safer in patients with coronary interventions, the device should further be explored in crossover trials for the two access types to determine the overall safety profile.