Fast track — ArticlesRadial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial
Introduction
In patients with acute coronary syndromes (ACS; ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation ACS [NSTE-ACS]), major bleeding is as common as recurrent myocardial infarction and occurs in about 5% of patients, depending on the definition used. A substantial proportion of the bleeding occurs at the vascular access site.1, 2, 3, 4 Findings from observational studies suggest that major bleeding is associated with increased risk of death and recurrent ischaemic events.5, 6 Vascular access via the radial artery—a superficial and readily compressible site—might result in less bleeding than access through the femoral artery. Also, observational studies have suggested a lower risk of death and myocardial infarction with radial than with femoral access, but these analyses are limited because of potential confounding factors.7, 8, 9 A meta-analysis of small randomised trials suggested that radial access might reduce major bleeding and was associated with weak evidence of a reduction in the composite of death, myocardial infarction, or stroke but also with weak evidence of an increased rate of percutaneous coronary intervention (PCI) failure.10 The individual trials were small, often single-centred, and underpowered to detect differences in important clinical events.
Accordingly, we did a large, multicentre, randomised trial among patients with ACS who were undergoing coronary angiography with possible intervention, to assess whether radial access was superior to femoral access.
Section snippets
Study design and patients
The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. The design of the RIVAL trial has been previously published.11 The RIVAL trial first enrolled patients within an investigator-initiated randomised substudy of the Clopidogrel and aspirin optimal dose Usage to Reduce Recurrent EveNTS—Seventh Organization to Assess Strategies in Ischemic Syndromes (CURRENT-OASIS 7) trial.12 The CURRENT-OASIS 7 trial was a randomised trial
Results
Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 142 of 597 CURRENT-OASIS 7 sites participated in RIVAL and these sites enrolled 3831 (45%) of 8515 of patients from CURRENT-OASIS 7 into RIVAL. 3190 additional patients were enrolled after CURRENT-OASIS 7 was completed. 3507 of 7021 patients were randomly assigned to radial access and 3514 to femoral access (figure 1). 7005 (99·8%) of 7021 patients underwent diagnostic coronary angiography.
Discussion
In patients with ACS undergoing coronary angiography, radial access did not reduce the primary outcome of death, myocardial infarction, stroke, or non-CABG-related major bleeding compared with femoral access. However, radial access significantly reduced vascular access complications compared with femoral access, with similar PCI success rates, and was more commonly preferred by patients for subsequent procedures. These results are consistent with a meta-analysis of all trials, including RIVAL (
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