Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial
Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial
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DOI：
10.1016/s0140-6736(11)60404-2
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发表时间：
2011-04-23
期刊：
影响因子：
168.9
通讯作者：
Mehta, Shamir R.
中科院分区：
文献类型：
--
作者：
Jolly, Sanjit S.;Yusuf, Salim;Mehta, Shamir R.
背景小型试验表明，桡动脉血管并发症和出血相比上级股动脉入路的患者急性血管造影术与可能的干预。经皮冠状动脉介入治疗（PCI）的入路减少了股动脉入路。我们的目的是评估桡动脉入路是否是接受冠状动脉介入治疗的冠状动脉综合征（ACS）。方法桡动脉与股动脉入路进行冠状动脉介入治疗（RIVAL）试验是一项随机、平行组、多中心试验。ACS患者通过24小时计算机中央自动语音响应系统随机分配（1：1）至桡动脉或股动脉入路。主要结局是30天时死亡、心肌梗死、卒中或非冠状动脉旁路移植术（非CABG）相关大出血的复合终点。关键次要结局为死亡、心肌梗死或卒中;以及30天时的非CABG相关大出血。设盲的中心委员会裁定主要结局、主要结局的组成部分和支架内血栓形成。所有其他结局均由研究者报告。患者和研究者对治疗分配不设盲。本试验注册于ClinicalTrials.gov，NCT 01014273。结果2006年6月6日至2010年11月3日，7021例患者入组，来自32个国家的158家医院。3507例患者被随机分配至桡动脉入路，3514例患者被随机分配至股动脉入路。桡动脉入路组3507例患者中有128例（3.7%）发生主要结局，股动脉入路组3514例患者中有139例（4.0%）发生主要结局（风险比[HR] 0.92，95% CI 0.72-1.17; p=0.50）。在6个预先设定的亚组中，在最高三分位容积桡动脉中心（HR 0.49，95% CI 0.28-0.87; p=0.015）和ST段抬高型心肌梗死患者（0.60，0.38-0.94; p=0.026）中，主要结局与桡动脉入路获益之间存在显著的相互作用。桡动脉组3507例患者中有112例（3.2%）在30天时发生死亡、心肌梗死或卒中，而股动脉组3514例患者中有114例（3.2%）在30天时发生死亡、心肌梗死或卒中（HR 0.98，95%CI 0.76-1.28; p= 0.90）。桡动脉组3507例患者中有24例（0.7%）患者在30天时发生非CABG相关大出血，而股动脉组3514例患者中有33例（0.9%）患者在30天时发生非CABG相关大出血（HR 0.73，95% CI 0.43-1.23; p=0. 23）。30天时，桡动脉组3507例患者中有42例出现大血肿，而股动脉组3514例患者中有106例出现大血肿（HR 0.40，95%CI 0-28-0.57; p
Background Small trials have suggested that radial vascular complications and bleeding compared with superior to femoral access in patients with acute angiography with possible intervention. access for percutaneous coronary intervention (PCI) reduces femoral access. We aimed to assess whether radial access was coronary syndromes (ACS) who were undergoing coronaryMethods The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT01014273.Findings Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3.7%) of 3507 patients in the radial access group compared with 139 (4.0%) of 3514 in the femoral access group (hazard ratio [HR] 0.92, 95% CI 0.72-1.17; p=0.50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0.49, 95% CI 0.28-0.87; p=0.015) and in patients with ST-segment elevation myocardial infarction (0.60, 0.38-0.94; p=0.026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3.2%) of 3507 patients in the radial group compared with 114 (3.2%) of 3514 in the femoral group (HR 0.98, 95% CI 0.76-1.28; p=0 90). The rate of non-CABG-related major bleeding at 30 days was 24 (0.7%) of 3507 patients in the radial group compared with 33 (0.9%) of 3514 patients in the femoral group (HR 0.73, 95% CI 0.43-1.23; p=0. 23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0.40, 95% CI 0-28-0.57; p