An international randomized trial of trans-radial versus trans-femoral PCI access site approach in patients with unstable angina or myocardial infarction managed with an invasive strategy
To evaluate two strategies for arterial access, femoral vs. radial, during heart catheterization for acute coronary syndromes. The RIVAL study is designed to establish whether the overall benefits versus risks of a radial artery approach justify its routine use in patients undergoing percutaneous coronary intervention. It is anticipated that the radial approach will reduce the frequency of bleeding events in patients managed with an invasive strategy.
Randomized, controlled, parallel group design.
Composite of death, MI, stroke or major bleeding at 30 days. Secondary Points: (1) Major bleeding at 48 hrs & 30 days after the procedure (2) Major vascular access site complications at 48 hrs & 30 days after the procedure (3) Composite of death, MI or stroke & each component taken separately at 48 hrs & 30 days; All primary and secondary endpoints are adjudicated