Author + information
- Received April 25, 2012
- Revision received June 25, 2012
- Accepted July 24, 2012
- Published online December 18, 2012.
- Shamir R. Mehta, MD, MSc⁎,⁎ (, )
- Sanjit S. Jolly, MD, MSc⁎,
- John Cairns, MD†,
- Kari Niemela, MD, PhD‡,
- Sunil V. Rao, MD§,
- Asim N. Cheema, MD, PhD∥,
- Philippe Gabriel Steg, MD¶,
- Warren J. Cantor, MD#,
- Vladimír Džavík, MD⁎⁎,
- Andrzej Budaj, MD, PhD††,
- Michael Rokoss, MD⁎,
- Vicent Valentin, MD‡‡,
- Peggy Gao, MSc⁎,
- Salim Yusuf, MBBS, DPhil⁎,
- RIVAL Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Shamir R. Mehta, Hamilton Health Sciences, General Division, David Braley Cardiac, Vascular and Stroke Institute, Room C3-119, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada
Objectives The purpose of this study was to determine the consistency of the effects of radial artery access in patients with ST-segment elevation myocardial infarction (STEMI) and in those with non–ST-segment elevation acute coronary syndrome (NSTEACS).
Background The safety associated with radial access may translate into mortality benefit in higher-risk patients, such as those with STEMI.
Methods We compared efficacy and bleeding outcomes in patients randomized to radial versus femoral access in RIVAL (RadIal Vs femorAL access for coronary intervention trial) (N = 7,021) separately in those with STEMI (n = 1,958) and NSTEACS (n = 5,063). Interaction tests between access site and acute coronary syndrome type were performed.
Results Baseline characteristics were well matched between radial and femoral groups. There were significant interactions for the primary outcome of death/myocardial infarction/stroke/non–coronary artery bypass graft–related major bleeding (p = 0.025), the secondary outcome of death/myocardial infarction/stroke (p = 0.011) and mortality (p = 0.001). In STEMI patients, radial access reduced the primary outcome compared with femoral access (3.1% vs. 5.2%; hazard ratio [HR]: 0.60; p = 0.026). For NSTEACS, the rates were 3.8% and 3.5%, respectively (p = 0.49). In STEMI patients, death/myocardial infarction/stroke were also reduced with radial access (2.7% vs. 4.6%; HR 0.59; p = 0.031), as was all-cause mortality (1.3% vs. 3.2%; HR: 0.39; p = 0.006), with no difference in NSTEACS patients. Operator radial experience was greater in STEMI versus NSTEACS patients (400 vs. 326 cases/year, p < 0.0001). In primary PCI, mortality was reduced with radial access (1.4% vs. 3.1%; HR: 0.46; p = 0.041).
Conclusions In patients with STEMI, radial artery access reduced the primary outcome and mortality. No such benefit was observed in patients with NSTEACS. The radial approach may be preferred in STEMI patients when the operator has considerable radial experience. (A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [RIVAL]; NCT01014273)
- percutaneous coronary intervention
- radial artery
- ST-segment elevation myocardial infarction
- vascular access
RIVAL was funded by a grant from the Canadian Network and Centre for Trials Internationally(CANNECTIN), an initiative of the Canadian Institutes of Health Research. RIVAL began as an investigator-initiated substudy of the CURRENT OASIS 7 trial, which was funded by a grant to the Population Health Research Institute (PHRI) from Sanofi and Bristol-Myers Squibb. Dr. Mehta has received an institutional research grant (to PHRI) from Sanofi-Aventis and Bristol-Myers Squibb; and consulting fees/honoraria (modest) from Abbott Vascular, Sanofi-Aventis, Eli Lilly, and AstraZeneca. Dr. Jolly has received an institutional research grant (to PHRI) from Sanofi-Aventis and Bristol-Myers Squibb and Medtronic; and consulting fees (modest) from Sanofi-Aventis, GlaxoSmithKline, Boehringer Ingelheim, and AstraZeneca. Dr. Cairns has recently chaired or has been a member of the Data and Safety Monitoring Boards of the following industry-sponsored trials: PALLAS (Sanofi-Aventis), ACTIVE trials (Sanofi-Aventis), AVERROES (BMS); he provides advice to Boehringer Ingelheim Canada and is a steering committee member of the TOTAL trial, which receives funding from Medtronic, Canada. Dr. Budaj has received consulting fees (modest) from Sanofi-Aventis, Eli Lilly, Novartis, AstraZeneca, and Merck; and grants from Sanofi Aventis, Boehringer Ingelheim, GlaxoSmithKline, Bristol-Myers Squibb, and AstraZeneca. Dr. Rao has received consultancy (modest) for Terumo Medical, Medicines Company, Eli Lilly, and Zoll. Dr. Steg has received institutional research grants from Servier; consulting to or honoraria (modest) from Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo-Lilly, GlaxoSmithKline, Merck, Otsuka, Roche, Sanofi-Aventis, Servier, and The Medicines Company; and has stock options in Aterovax. Dr. Džavík is a consultant to Abbott Vascular, Cordis, and Johnson & Johnson. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 25, 2012.
- Revision received June 25, 2012.
- Accepted July 24, 2012.
- American College of Cardiology Foundation