Thomas Stiermaier, Matthias Grünewälder, Toni Pätz, Elias Rawish, Alexander Joost, Moritz Meusel, Christoph Marquetand, Thomas Kurz, Tobias Schmidt, Christian Frerker, Georg Fuernau, Ingo Eitel
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Patients with indicated percutaneous coronary intervention (PCI) were excluded from the analysis. The primary endpoints were the incidence of RAO, assessed by vascular ultrasound, and bleeding events.</p><p><strong>Results: </strong>The trial was stopped early for efficacy by the data and safety monitoring board after the second preplanned interim analysis and inclusion of 600 participants. Excluding patients with indicated PCI, the final study population consisted of 439 patients. Distal TRA was associated with more access site crossovers (14.9% vs 8.3%; p=0.032) and a longer total procedure time (25 min vs 20 min; p=0.001) than conventional TRA. The rates of RAO (20.3% vs 21.2%; p=0.810) and bleeding events (4.1% vs 6.9%; p=0.188) were similar after distal and conventional TRA. In contrast, procedural AC reduced the incidence of RAO (7.3% vs 33.9%; p<0.001) without increasing bleeding risk (7.3% vs 3.6%; p=0.087). 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引用次数: 0
摘要
背景：桡动脉远端经桡动脉通路（TRA）和程序性抗凝（AC）是预防桡动脉闭塞（RAO）的两种策略，但证据不足。目的：本研究评估冠状动脉造影（CAG）患者不同的桡动脉通路位置和程序性AC的有效性和安全性。方法：RAPID试验是一项单中心、开放标签、2x2因子研究，随机将患者分为程序性AC和非程序性AC，以及远端TRA和传统TRA，并根据已存在的口服AC进行进一步分层。经皮冠状动脉介入治疗（PCI）的患者被排除在分析之外。主要终点是血管超声评估的RAO发生率和出血事件。结果：在第二次预先计划的中期分析和纳入600名参与者后，数据和安全监测委员会提前停止了试验的有效性。排除有PCI指征的患者，最终研究人群包括439例患者。远端TRA与更多的通路位点交叉相关(14.9% vs 8.3%；P =0.032)，总手术时间更长(25分钟vs 20分钟；p=0.001)。RAO发生率(20.3% vs 21.2%；P =0.810)和出血事件(4.1% vs 6.9%；p=0.188)。相比之下，程序性AC降低了RAO的发生率(7.3% vs 33.9%；结论：虽然远端TRA不能降低RAO的风险，但程序性AC对所有接受经桡动脉CAG的患者都有效，包括那些已经接受过口服AC的患者。ClinicalTrials.gov: NCT04301921 [RAPID-1]和NCT04362020 [RAPID-2])。
Distal access and procedural anticoagulation to prevent radial artery occlusion after coronary angiography - the randomised RAPID trial.
Background: Distal transradial access (TRA) and procedural anticoagulation (AC) are among the strategies to prevent radial artery occlusion (RAO) that have some gaps in evidence.
Aims: This study assessed the efficacy and safety of different radial access sites and procedural AC in patients undergoing coronary angiography (CAG).
Methods: The RAPID trial is a single-centre, open-label, 2x2 factorial study that randomised patients to procedural AC versus no procedural AC and also to distal versus conventional TRA with further stratification according to pre-existing oral AC. Patients with indicated percutaneous coronary intervention (PCI) were excluded from the analysis. The primary endpoints were the incidence of RAO, assessed by vascular ultrasound, and bleeding events.
Results: The trial was stopped early for efficacy by the data and safety monitoring board after the second preplanned interim analysis and inclusion of 600 participants. Excluding patients with indicated PCI, the final study population consisted of 439 patients. Distal TRA was associated with more access site crossovers (14.9% vs 8.3%; p=0.032) and a longer total procedure time (25 min vs 20 min; p=0.001) than conventional TRA. The rates of RAO (20.3% vs 21.2%; p=0.810) and bleeding events (4.1% vs 6.9%; p=0.188) were similar after distal and conventional TRA. In contrast, procedural AC reduced the incidence of RAO (7.3% vs 33.9%; p<0.001) without increasing bleeding risk (7.3% vs 3.6%; p=0.087). These results were consistent in patients on pre-existing oral AC and those with distal TRA.
Conclusions: While distal TRA did not reduce the risk of RAO, procedural AC proved effective in all patients undergoing transradial CAG including those on pre-existing oral AC. (Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography [RAPID] trial; ClinicalTrials.gov: NCT04301921 [RAPID-1] and NCT04362020 [RAPID-2]).
期刊介绍：
EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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