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A randomized comparison of RadIal Vs. femorAL access for coronary intervention in ACS (RIVAL)

A randomized comparison of RadIal Vs. femorAL access for coronary intervention in ACS (RIVAL).

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A randomized comparison of RadIal Vs. femorAL access for coronary intervention in ACS (RIVAL)

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  1. A randomized comparison of RadIal Vs. femorAL access for coronary intervention in ACS (RIVAL) SS Jolly, S Yusuf, J Cairns, K Niemela, D Xavier, P Widimsky, A Budaj, M Niemela, V Valentin, BS Lewis, A Avezum, PG Steg, SV Rao, P Gao, R Afzal, CD Joyner, S Chrolavicius, SR Mehta on behalf of the RIVAL investigators

  2. Disclosures Funded by: • Sanofi-Aventis and Bristol-Myers Squibb (RIVAL sub-study of CURRENT/OASIS 7) • Population Health Research Institute • CANadian Network and Centre for Trials INternationally (CANNeCTIN, an initiative of Canadian Institutes of Health Research)

  3. Bleeding is associated with Death and Ischemic Events HR 5.37 (3.97-7.26) N=34,146 OASIS Registry, OASIS 2, CURE trials HR 4.44 (3.16-6.24) HR 6.46 (3.54-11.79) Eikelboom JW et al. Circulation 2006;114(8):774-82.

  4. Prior Meta-analysis of 23 RCTs of Radial vs. Femoral (N=7030) Major bleeding 0.27 (0.16-0.45) Death 0.74 (0.42-1.30) Death, MI or stroke 0.71 (0.49-1.01) PCI Procedure Failure 1.31 (0.87-1.96) 1.0 Radial better Femoral better Jolly SS, et al. Am Heart J 2009;157:132-40.

  5. RIVAL Study Objective - To determine if Radial vs. Femoral access for coronary angiography/PCI can reduce the composite of death, MI, stroke or non-CABG major bleeding in ACS patients

  6. RIVAL Study Design NSTE-ACS and STEMI (n=7021) • Key Inclusion: • Intact dual circulation of hand required • Interventionalist experienced with both (minimum 50 radial procedures in last year) Randomization Radial Access (n=3507) Femoral Access (n=3514) Blinded Adjudication of Outcomes Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days Jolly SS et al. Am Heart J. 2011;161:254-60.

  7. Definitions

  8. Final Recruitment RIVAL sub-study during OASIS 7/CURRENT N= 3831 RIVAL Stand-Alone After CURRENT N= 3190 + RIVAL Total N=7,021 Follow-up complete in 99.9% CURRENT-OASIS 7. N Engl J Med. 2010;363:930-42. Mehta SR, et al. Lancet. 2010; 376:1233-43.

  9. International Study North America 1614 Europe 3564 Asia 1117 Middle East/Israel 239 South America 423 Australia and New Zealand 64

  10. Baseline Characteristics

  11. Therapies - Initial Hospitalization

  12. Operator VolumeProcedure Characteristics • Vascular closure devices used in 26% of Femoral group

  13. Primary and Secondary Outcomes

  14. Other Outcomes * Post Hoc analysis

  15. Other Outcomes

  16. Other Outcomes • Symptomatic radial occlusion requiring medical attention 0.2% in radial group

  17. Site of Non-CABG Major Bleeds (RIVAL definition) *Sites of Non Access site Bleed: Gastrointestinal (most common site), ICH, Pericardial Tamponade and Other

  18. R I V A L Subgroups: Primary Outcome Death, MI, Stroke or non-CABG major Bleed Overall p-value Interaction Age <75 ≥75 0.786 Gender Female 0.356 Male BMI <25 25-35 0.637 >35 Radial PCI Volume by Operator ≤70 70-142.5 >142.5 0.536 Radial PCI Volume by Centre Lowest Tertile Middle Tertile Highest Tertile 0.021 Diagnosis at presentation NSTE-ACS 0.025 STEMI 0.25 1.00 4.00 Radial better Femoral better Hazard Ratio (95% CI)

  19. R I V A L Results stratified by High*, Medium* and Low* Volume Radial Centres *High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60) Tertiles of Radial PCI Centre Volume/yr p-value HR (95% CI) Interaction Primary Outcome High 0.021 Medium Low Death, MI or stroke 0.013 High Medium Low Non CABG Major Bleed High Medium 0.538 Low Major Vascular Complications 0.019 High Medium Low Access site Cross-over 0.003 High Medium Low No significant interaction by Femoral PCI center volume 0.25 1.00 4.00 16.00 Radial better Femoral better Hazard Ratio(95% CI)

  20. R I V A L Outcomes stratified by STEMI vs. NSTEACS % % 2N Radial Femoral Interaction p-value Primary Outcome NSTE/ACS 5063 3.8 3.5 0.025 STEMI 1958 3.1 5.2 Death, MI or stroke NSTE/ACS 5063 3.4 2.7 0.011 STEMI 1958 2.7 4.6 Death NSTE/ACS 5063 1.2 0.8 0.001 STEMI 1958 1.3 3.2 Non CABG Major Bleed NSTE/ACS 5063 0.6 1.0 0.56 STEMI 1958 0.8 0.9 Major Vascular Complications NSTE/ACS 5063 1.4 3.8 0.89 STEMI 1958 1.3 3.5 0.25 1.00 4.00 Radial better Femoral better Hazard Ratio(95% CI)

  21. Conclusion • No significant difference between radial and femoral access in primary outcome of death, MI, stroke or non-CABG major bleeding • Rates of primary outcome appeared to be lower with radial compared to femoral access in high volume radial centres and STEMI • Radial had fewer major vascular complications with similar PCI success

  22. Implications • Both radial and femoral approaches are safe and effective • Increasing experience may improve outcomes with radial access • Clinicians and patients may choose radial because of its similar efficacy and reduced vascular complications

  23. Available Online at www.lancet.com

  24. Acknowledgements RIVAL Investigators from 158 sites in 32 countries

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