RIVAL study: RadIal Vs. femoral access for coronary intervention in patients with acute coronary syndromes study. Sanjit Jolly MD, MSc FRCPC
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1 RIVAL study: RadIal Vs. femoral access for coronary intervention in patients with acute coronary syndromes study Sanjit Jolly MD, MSc FRCPC
2 Rationale Prior small trials and meta-analyses have demonstrated that radial vs. femoral access reduces vascular access site complications Radial access remains underutilized with 6-12% procedures worldwide
3 Strong Independent Association with Bleeding and Death, MI and Stroke HR 5.37 ( ) HR 4.44 ( ) Analysis OASIS Registry, OASIS 2, CURE (N=34,126) HR 6.46 ( ) Eikelboom JW et al. Circulation 2006;114(8):
4 New Paradigms 1) Major bleeding is as important as MI, in terms of predicting subsequent mortality 2) Major Bleeding events may lead to death and Recurrent MI Ndrepepa G, et al. JACC. 2008;51(7): Eikelboom JW et al. Circulation 2006;114(8):
5 Updated Meta-analysis of Radial vs. Femoral RCTs Study name Radial Peto Femoral odds ratio ACCESS 0 / / Achenbach 0 / / Bodi 3 / / BRAFE 0 / 50 1 / FARMI 3 / 57 3 / Gorge 1 / / Mann / 68 2 / OCTOPLUS 1 / / OUTCLAS 0 / / RADIAL AMI 1 / 25 4 / RADIAMI 3 / 50 7 / TEMPURA 0 / 77 2 / Vazquez-Rodriguez 1 / / / / Heterogeneity Q=22.03, df=16, p=0.14 Major Bleeding Peto odds ratio and 95% CI OR 0.27 (95% CI 0.16, 0.45) p<0.001 Heterogeneity p=0.93, i 2 =0% Favours Radial Favours Femoral Jolly SS, et al. Am Heart J. 2009;157:
6 Updated Meta-analysis of Radial vs. Femoral RCTs Study name Peto Radial Femoral odds ratio ACCESS 11 / / Achenbach 0 / / Bodi 7 / / BRAFE 2 / 50 2 / Cooper 0 / / FARMI 6 / 57 6 / OCTOPLUS 7 / / OUTCLAS** 7 / / RADIAL AMI 0 / 25 1 / RADIAMI 1 / 50 2 / TEMPURA* 4 / 77 6 / Vazquez-Rodriguez 11 / / / / Heterogeneity Q=22.03, df=16, p=0.14 Death, MI or Stroke OR 0.71 (95% CI 0.49, 1.01) p=0.058 Peto odds ratio and 95% CI Heterogeneity p=0.59, i 2 =0% Favours Radial Favours Femoral Trend for a reduction in death, MI or stroke with radial Jolly SS, et al. Am Heart J. 2009;157:
7 Hypothesis Radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach This reduction in bleeding complications will translate into lower rates of death and ischemic complications
8 Study Objective To determine if radial compared to femoral access in patients with NSTEACS and STEMI can reduce the rate of death, MI, Stroke or major bleeding at 30 days
9 Non STEACS and STEMI (n=7000) Randomization Intent to treat Analysis Radial Access (n=3500) Femoral Access (n=3500) 30 day follow-up 30 day follow-up Primary Outcome: Death, MI, stroke or major bleeding at 30 days
10 Recruitment as of April 26, 2010 Started as a sub-study of the CURRENT trial in June 2006 Extended to a stand alone trial in March 2008 Study Arm CURRENT Substudy (Randomizing June 2006 June 2009) RIVAL Stand-alone (Randomizing March 2008 to present) CURRENT Substudy Extension (Randomizing December 2009 to present) Number of Patients Randomized Overall RIVAL Trial as of April 26,
11 Recruitment as of April 26, 2010
12 Top 12 Recruiting Countries as of April 26, 2010
13 Country Top 12 Recruiting Countries CURRENT Substudy as of April 26, 2010 RIVAL Stand-alone CURRENT Substudy Extension Overall RIVAL Program Canada Finland India Bulgaria Poland Spain China Israel Brazil Chile Czech Republic United States
14 Projected vs. Actual Recruitment as of April 26, 2010 Cumulative No. of Sites Cumulative Recruitment
15 Weekly Recruitment as of April 26, 2010
16 CIHR Funding Application Update Applied for CIHR funding in Sept 2009 with a number of co-applicants from the CANNECTIN network Not approved- feedback, will the trial change practice (KT) Re-applied for CIHR funding in March 2010 after performing a national survey to assess impact of our trial
17 Study Completion Based on current recruitment, RIVAL trial will be complete enrolment in November 2010 Plans to present at ACC in March 2011
18 Special Recognition for the Efforts of: RIVAL & CURRENT National Coordinators CANNECTIN collaborators RIVAL & CURRENT study team
19 RIVAL Project Office Study Team Principal Investigators: Dr. Sanjit Jolly MD, MSc, FRCPC Steering Committee Chairs: Dr. Salim Yusuf, MBBS, PhD, FRCPC Dr. Shamir Mehta MD, MSc, FRCPC, FACC Dr. John Cairns, MD, FRCPC Project Manager: Susan Chrolavicius Research Coordinators: Caley Cramp Adjudication Coordinator: Mitzi Lawrence, RN BScN Barbara Jedrzejowski
Methods Search strategy for identification of studies
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