Muddasir Ashraf, Suhail Q. Allaqaband, Louis Kostopoulos, Babak Haddadian, Tanvir Bajwa, Tonga Nfor, Jayant Khitha, Khawaja Afzal Ammar, Ahmad Khraisat, Robert Richmond, Sara Walczak, Wendy Dunaj, Viviana Zlochiver, Kritika Garg, Ana Cristina Perez Moreno, Kirsten Tunink, Theresa Briggs, Jane Meitler, Michelle Bennett, M. Fuad Jan
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Fuad Jan","doi":"10.1155/joic/1447277","DOIUrl":null,"url":null,"abstract":"<div>\n <p><b>Background:</b> 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.</p>\n <p><b>Objective:</b> 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).</p>\n <p><b>Methods:</b> 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. 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(Radial Artery Vascular Complication and Resource Utilization [RAVE]).</p>\n <p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT03522077</p>\n </div>","PeriodicalId":16329,"journal":{"name":"Journal of interventional cardiology","volume":"2025 1","pages":""},"PeriodicalIF":1.6000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/joic/1447277","citationCount":"0","resultStr":"{\"title\":\"Comparison of Radial Artery Compression Techniques in Contemporary Cardiovascular Practice: The RAVE Trial\",\"authors\":\"Muddasir Ashraf, Suhail Q. Allaqaband, Louis Kostopoulos, Babak Haddadian, Tanvir Bajwa, Tonga Nfor, Jayant Khitha, Khawaja Afzal Ammar, Ahmad Khraisat, Robert Richmond, Sara Walczak, Wendy Dunaj, Viviana Zlochiver, Kritika Garg, Ana Cristina Perez Moreno, Kirsten Tunink, Theresa Briggs, Jane Meitler, Michelle Bennett, M. 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引用次数: 0
摘要
背景：经桡动脉心导管术患者较短的止血时间可减少并发症，减轻疼痛，促进早期出院，提高患者满意度。目的：本试验旨在评估SoftSeal-STF （Chitogen Inc., Plymouth， MN）与仅使用RCD （Vasc Band）的患者相比，单独使用手动压迫或联合使用径向压迫装置（RCD）是否会缩短止血时间。方法：我们招募了300名患者，分为4组，包括SoftSeal-STF手动加压、Vasc Band（标准护理）、SoftSeal-STF with TR Band和SoftSeal-STF with easyclick。由于修改了随机试验的设计，本研究被分析为一项观察性研究。主要观察指标为止血时间；次要结果为出院前并发症、3天随访和随访办公室访问（术后30-45天）。结果：SoftSeal-STF + TR Band组和SoftSeal-STF + easyclick组的中位止血时间（四分位数间距[IQR]）明显低于Vasc Band组(45 [40-69]min vs. 120 [120 - 124] min, p <；0.0001;[40-58.5]分钟vs[120 - 124]分钟，p <；分别为0.0001)。SoftSeal-STF + TR Band与SoftSeal-STF + easyclick两组的中位止血时间（45 [40-69]min vs. 44 [40-58.5] min, p = 0.3）无显著差异。SoftSeal-STF +手动按压组的中位止血时间（IQR）最低（19[15-30]分钟），但这些患者术后疼痛和瘀伤较多，并伴有导管实验室的后勤问题。结论：SoftSeal-STF + RCD对于经桡动脉心导管置入术患者是一种安全、省时的策略。（桡动脉血管并发症和资源利用[RAVE]）。试验注册：ClinicalTrials.gov标识符：NCT03522077
Comparison of Radial Artery Compression Techniques in Contemporary Cardiovascular Practice: The RAVE Trial
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]).
期刊介绍：
Journal of Interventional Cardiology is a peer-reviewed, Open Access journal that provides a forum for cardiologists determined to stay current in the diagnosis, investigation, and management of patients with cardiovascular disease and its associated complications. The journal publishes original research articles, review articles, and clinical studies focusing on new procedures and techniques in all major subject areas in the field, including:
Acute coronary syndrome
Coronary disease
Congenital heart diseases
Myocardial infarction
Peripheral arterial disease
Valvular heart disease
Cardiac hemodynamics and physiology
Haemostasis and thrombosis
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