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Research

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RIVAL

Official Title

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

Status

Completed

Overview

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.

Study Design

Randomized, controlled, parallel group design.

Primary Endpoint

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

Number of Patients

7021

Number of Sites

59

Number of Countries

18

Study Period

2008–2010

Principal Investigator

Sanjit Jolly

Program Manager

Susan Chrolavicius

Research Coordinator

Barbara Jedrzejowski

Collaborators

CANNECTIN

Key Publications

  • Sanjit S Jolly, Salim Yusuf, John Cairns, Kari Niemelä, Denis Xavier, Petr Widimsky, Andrzej Budaj, Matti Niemelä, Vicent Valentin, Basil S Lewis, Alvaro Avezum, Philippe Gabriel Steg, Sunil V Rao, Peggy Gao, Rizwan Afzal, Campbell D Joyner, Susan Chrolavicius, Shamir R Mehta; Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. The Lancet published Online 04 April, 2011 DOI:10.1016/S0140-6736(11)60404-2