Elsevier

The Lancet

Volume 377, Issue 9775, 23–29 April 2011, Pages 1409-1420
The Lancet

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Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial

https://doi.org/10.1016/S0140-6736(11)60404-2Get rights and content

Summary

Background

Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention.

Methods

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<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13–0·71; p=0·006).

Interpretation

Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach.

Funding

Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research.

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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