Review of the RIVAL Trial

Transradial has lower vascular complication, bleeding rates than transfemoral access
By: 
Adhir Shroff, M.D., MPH

 

May 18, 2011
Figure 1: Access site and bleeding outcomes from the RIVAL trial.

The results of the highly anticipated RIVAL (RadIal Vs. femorAL access for coronary intervention)[1,2] trial were presented April 4 at the American College of Cardiology’s 2011 Scientific Session in New Orleans. The basis of the trial was to investigate the efficacy and safety of the transradial approach as compared to the femoral approach in patients being treated with an invasive strategy for an acute coronary syndroThe results of the highly anticipated RIVAL (RadIal Vs. femorAL access for coronary intervention)[1,2] trial were presented April 4 at the American College of Cardiology’s 2011 Scientific Session in New Orleans.  The basis of the trial was to investigate the efficacy and safety of the transradial approach as compared to the femoral approach in patients being treated with an invasive strategy for an acute coronary syndrome.

Presenting the results was Sanjit Jolly, M.D., M.Sc., assistant professor of medicine at McMaster University in Hamilton, Ontario, Canada, who explained the radial approach affords a decrease in bleeding and vascular complications.  Several reports have linked bleeding events following coronary intervention to an increased risk of death. Prior to this study, there have been only retrospective studies or pooled analyses that have suggested the radial approach as superior to femoral artery access.

Patients with an acute coronary syndrome were randomized to either the transradial or transfemoral approach. Anticoagulation strategy was left to the discretion of the operator. More than 7,000 patients were included in this multicenter study. The primary endpoints included the occurrence of death, myocardial infarction, stroke or non-coronary artery bypass graft related major bleeding within 30 days.

The key findings of the study included:
• Primary outcome was equivalent between radial and femoral groups (3.7 vs. 4 percent, p=0.50)
• Less vascular access site complications with radial compared to femoral access (p<0.0001) (Figure 1)
• Access site crossover was higher in the radial group (7.6 vs. 2 percent, p<0.0001)
• All access site major bleeds in the radial group occurred in those patients who crossed over to the femoral group
• High-volume radial centers had a benefit for the primary outcome compared with femoral access group (p=0.021)
• Patients with ST-elevated myocardial infarction (STEMI) benefited from transradial access for the composite endpoint of death, heart attack and stroke (p=0.011) and death alone (p=0.001) (Figure 2)

In summary, the authors concluded there was no difference in rates of composite death, myocardial infarction, stroke or major bleeding between access strategies, but radial access decreased major vascular complications. Expertise with the transradial technique and procedure volume may be linked to the effectiveness of this approach.

References:
1.    Jolly SS, Niemelä K, Xavier D, et al. “Design and rationale of the RadIal Vs. femorAL access for coronary intervention (RIVAL) trial: A randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes.” American Heart Journal 2011, 161:254-60.

2.    Jolly SS, Yusuf S, Cairns J, Kari Niemelä DX, Petr Widimsky, Andrzej Budaj, Matti Niemelä, Vicent Valentin, Basil S Lewis,, Alvaro Avezum PGS, Sunil V Rao, Peggy Gao, Rizwan Afzal, Campbell D Joyner, Susan Chrolavicius, Shamir R Mehta, for the group. “Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.” Lancet 2011.

3.    Jolly SS. “A randomized comparison of RadIal Vs. femorAL access for coronary intervention in ACS (RIVAL).” American College of Cardiology Scientific Sessions, New Orleans, 2011.

  • Figure 2: Outcomes of patients with STEMI versus non-STEMI from the RIVAL trial.