RIVAL: Radial access PCI linked to reduced access-site complications
MedWire News: Both femoral and radial approaches to percutaneous coronary intervention (PCI) are effective, but use of radial access is associated with a significantly lower rate of vascular access site complications than conventional femoral access, according to results of the RIVAL trial.
The trial compared 30-day event rates in 7021 myocardial infarction (MI) patients from 158 centers in 32 countries randomly assigned by a central computer to undergo PCI with radial or femoral access.
The primary composite endpoint of death, MI, stroke, or non-coronary artery bypass graft (CABG) major bleeding at 30 days occurred in 3.7% of patients in the radial access group and 4.0% of those in the femoral access group - a nonsignificant difference .
A stratified analysis showed that the benefits associated with radial access were greatest in high-volume treatment centers, which also had the lowest overall vascular complication rates.
"Clinicians and patients may choose radial access because of its similar efficacy and reduced vascular complications," said lead investigator Sanjit Jolly (McMaster University, Hamilton, Ontario, Canada), speaking at the American College of Cardiology Annual Scientific Sessions in New Orleans, Louisiana, USA.
Major bleeding is a common complication of PCI, occurring in about 5% of patients, approximately the same incidence as recurrent MI, explain the RIVAL (RadIal Vs femorAL access for coronary intervention) investigators. Major bleeding is also associated with increased risk for death, MI, and stroke, said Jolly.
The RIVAL trial was an investigator-initiated substudy of the CURRENT-OASIS 7 trial, which compared clopidogrel doses in patients with acute coronary syndromes (ACS). The goal of RIVAL was to see whether radial access for coronary angiography and PCI could reduce the composite of death, MI, stroke, or non-CABG major bleeding in patients with ACS.
The authors defined major bleeding according to the CURRENT-OASIS 7 criteria of fatality, the need for 2 or more units of blood, hypotension requiring inotropic agents, required surgical intervention, or intracranial hemorrhage/intraocular bleeding leading to significant vision-loss.
Major vascular access site complications were defined as large hematoma, pseudoaneurysm requiring closures, arterio-venous fistula, or other vascular surgery related to the access site.
There was no significant difference between groups in the primary outcome, nor were there differences in pre-specified secondary endpoints of the composite of death, MI, and stroke (3.2% in each group; p=0.90) or non-CABG major bleeding considered alone (0.7% for radial access vs 0.9% for femoral; p=0.23). There were also no differences in the individual categories of death, MI, stroke, or stent thrombosis.
Radial access , however, was associated with a lower incidence of major vascular access site complications than femoral access, at 1.4% versus 3.7% (hazard ratio [HR]=0.37; p<0.0001), and in a post-hoc analysis, with a lower incidence of non-CABG major bleeding as defined in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategy) trial, at 1.9% versus 4.5% (HR= 0.43; p<0.0001).
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By Neil Osterweil