TY - JOUR
T1 - Comparison of Radial Artery Compression Techniques in Contemporary Cardiovascular Practice: The RAVE Trial
AU - Ashraf, Muddasir
AU - Allaqaband, Suhail Q.
AU - Kostopoulos, Louis
AU - Haddadian, Babak
AU - Bajwa, Tanvir
AU - Nfor, Tonga
AU - Khitha, Jayant
AU - Ammar, Khawaja Afzal
AU - Khraisat, Ahmad
AU - Richmond, Robert
AU - Walczak, Sara
AU - Dunaj, Wendy
AU - Zlochiver, Viviana
AU - Garg, Kritika
AU - Perez Moreno, Ana Cristina
AU - Tunink, Kirsten
AU - Briggs, Theresa
AU - Meitler, Jane
AU - Bennett, Michelle
AU - Jan, M. Fuad
N1 - Publisher Copyright:
Copyright © 2025 Muddasir Ashraf et al. Journal of Interventional Cardiology published by John Wiley & Sons Ltd.
PY - 2025/2/6
Y1 - 2025/2/6
N2 - Background: The shorter time to hemostasis in patients who undergo transradial cardiac catheterization may reduce the complications, cause less pain, facilitate early discharge, and improve patient satisfaction. Objective: This trial aimed to evaluate if SoftSeal-STF (Chitogen Inc., Plymouth, MN) with manual compression alone or in combination with a radial compression device (RCD) would reduce time to hemostasis compared to patients with RCD only (Vasc Band). Methods: We enrolled 300 patients in four arms, including SoftSeal-STF with manual compression, Vasc Band (standard of care), SoftSeal-STF with TR Band, and SoftSeal-STF with EasyClik. This study was analyzed as an observational study due to modification in the design of a randomized trial. The primary outcome was time to hemostasis; the secondary outcomes were complications before discharge, a 3 day follow-up, and a follow-up office visit (30–45 days postprocedure). Results: The median time to hemostasis (interquartile range [IQR]) was significantly lower in the SoftSeal-STF + TR Band group and the SoftSeal-STF + EasyClik group than in the Vasc Band group (45 [40–69] minutes vs. 120 [120–124] minutes, p < 0.0001; 44 [40–58.5] minutes vs. 120 [120–124] minutes, p < 0.0001, respectively). The median time to hemostasis (IQR) was not different between SoftSeal-STF + TR Band and SoftSeal-STF + EasyClik (45 [40–69] minutes vs. 44 [40–58.5] minutes, p = 0.3). The median time to hemostasis (IQR) was lowest in the SoftSeal-STF + manual compression group (19 [15–30] minutes), but these patients had more postoperative pain and bruising along with logistic issues within the catheterization lab. Conclusion: The SoftSeal-STF + RCD is a safe and time-efficient strategy in patients who undergo transradial cardiac catheterization. (Radial Artery Vascular Complication and Resource Utilization [RAVE]). Trial Registration: ClinicalTrials.gov identifier: NCT03522077.
AB - Background: The shorter time to hemostasis in patients who undergo transradial cardiac catheterization may reduce the complications, cause less pain, facilitate early discharge, and improve patient satisfaction. Objective: This trial aimed to evaluate if SoftSeal-STF (Chitogen Inc., Plymouth, MN) with manual compression alone or in combination with a radial compression device (RCD) would reduce time to hemostasis compared to patients with RCD only (Vasc Band). Methods: We enrolled 300 patients in four arms, including SoftSeal-STF with manual compression, Vasc Band (standard of care), SoftSeal-STF with TR Band, and SoftSeal-STF with EasyClik. This study was analyzed as an observational study due to modification in the design of a randomized trial. The primary outcome was time to hemostasis; the secondary outcomes were complications before discharge, a 3 day follow-up, and a follow-up office visit (30–45 days postprocedure). Results: The median time to hemostasis (interquartile range [IQR]) was significantly lower in the SoftSeal-STF + TR Band group and the SoftSeal-STF + EasyClik group than in the Vasc Band group (45 [40–69] minutes vs. 120 [120–124] minutes, p < 0.0001; 44 [40–58.5] minutes vs. 120 [120–124] minutes, p < 0.0001, respectively). The median time to hemostasis (IQR) was not different between SoftSeal-STF + TR Band and SoftSeal-STF + EasyClik (45 [40–69] minutes vs. 44 [40–58.5] minutes, p = 0.3). The median time to hemostasis (IQR) was lowest in the SoftSeal-STF + manual compression group (19 [15–30] minutes), but these patients had more postoperative pain and bruising along with logistic issues within the catheterization lab. Conclusion: The SoftSeal-STF + RCD is a safe and time-efficient strategy in patients who undergo transradial cardiac catheterization. (Radial Artery Vascular Complication and Resource Utilization [RAVE]). Trial Registration: ClinicalTrials.gov identifier: NCT03522077.
KW - PCI
KW - radial artery
KW - SoftSeal-STF
KW - vascular compression device
UR - https://www.scopus.com/pages/publications/105001683703
UR - https://www.scopus.com/pages/publications/105001683703#tab=citedBy
U2 - 10.1155/joic/1447277
DO - 10.1155/joic/1447277
M3 - Article
AN - SCOPUS:105001683703
SN - 0896-4327
VL - 2025
JO - Journal of Interventional Cardiology
JF - Journal of Interventional Cardiology
IS - 1
M1 - 1447277
ER -