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)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 Steering committee
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R I V A L
DisclosuresDisclosures
Funded by: Funded by: Sanofi-Aventis and Bristol-Myers Squibb Sanofi-Aventis and Bristol-Myers Squibb (RIVAL sub-study of CURRENT/OASIS 7) (RIVAL sub-study of CURRENT/OASIS 7) Population Health Research InstitutePopulation Health Research Institute CANadian Network and Centre for Trials CANadian Network and Centre for Trials INternationally (CANNeCTIN, an initiative of INternationally (CANNeCTIN, an initiative of Canadian Institutes of Health Research) Canadian Institutes of Health Research)
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R I V A L
Bleeding is associated with Bleeding is associated with Death and Ischemic EventsDeath and Ischemic Events
Eikelboom JW et al. Circulation 2006;114(8):774-82.
HR 5.37 (3.97-7.26)
HR 4.44 (3.16-6.24)
HR 6.46 (3.54-11.79)
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R I V A L
Prior Meta-analysis of 23 RCTs of Radial vs. Femoral (N=7030)
Radial better Femoral better1.0
PCI Procedure Failure
Death
Death, MI or stroke
Major bleeding
1.31 (0.87-1.96)
0.74 (0.42-1.30)
0.71 (0.49-1.01)
0.27 (0.16-0.45)
Jolly SS, et al. Am Heart J 2009;157:132-40.
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R I V A L
RIVAL Study Objective
- To determine if Radial vs. Femoral access for coronary - To determine if Radial vs. Femoral access for coronary angiography/PCI can reduce the composite of death, MI, angiography/PCI can reduce the composite of death, MI, stroke or non-CABG major bleeding in ACS patientsstroke or non-CABG major bleeding in ACS patients
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R I V A L
NSTE-ACS and STEMI(n=7021)
Radial Access(n=3507)
Femoral Access(n=3514)
Primary Outcome: Death, MI, stroke or non-CABG-related Major Bleeding at 30 days
Randomization
RIVAL StudyRIVAL Study Design Design
Key Inclusion: •Intact dual circulation of hand required•Interventionalist experienced with both (minimum 50 radial procedures in last year)
Jolly SS et al. Am Heart J. 2011;161:254-60.
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R I V A L
Study Outcome DefinitionsStudy Outcome DefinitionsMajor Bleeding (CURRENT/OASIS 7)
• Fatal• > 2 units of Blood transfusion• Hypotension requiring inotropes• Requiring surgical intervention • ICH or Intraocular bleeding leading to significant vision loss
Major Vascular Access Site Complications
• Large hematoma• Pseudoaneurysm requiring closure• AV fistula• Other vascular surgery related to the access site
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R I V A L
Final RecruitmentFinal Recruitment
RIVAL Stand-AloneAfter CURRENT
N= 3190
RIVALTotal
N=7,021
RIVAL sub-study during OASIS 7/CURRENT
N= 3831 +
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.
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R I V A L
International StudyInternational Study
Middle East/Israel 239
Australia and New Zealand 64
North America 1614
South America 423
Asia 1117
Europe 3564
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R I V A L
Baseline CharacteristicsBaseline Characteristics
Radial Radial (n =3507)(n =3507)
Femoral Femoral (n =3514)(n =3514)
Mean Age (years) 62 62
Male (%) 74.1 72.9
Diabetes (%) 22.3 20.5
Diagnosis at presentation
UA (%) 44.3 45.7
NSTEMI (%) 28.5 25.8
STEMI (%) 27.2 28.5
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R I V A L
Therapies - Initial HospitalizationTherapies - Initial HospitalizationRadialRadial(n=3507)(n=3507)
%%
FemoralFemoral (n=3514) (n=3514)
%%
ASA 99.2 99.3
Clopidogrel 96.0 95.6
LMWH 51.5 51.8
UFH 33.3 31.6
Fondaparinux 10.9 10.8
Bivalirudin 2.2 3.1
GP IIb IIIa inhibitors 25.3 24.0
PCI 65.9 66.8
CABG 8.8 8.3
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R I V A L
Operator VolumeOperator VolumeProcedure CharacteristicsProcedure Characteristics
Radial Radial (n=3507) (n=3507)
Femoral Femoral (n=3514)(n=3514) HR (95% CI)HR (95% CI) PP
valuevalueOperator Annual Volume
PCI/year (median, IQR)
300 (190, 400)
300 (190,400)
Percent Radial PCI(median, IQR)
40 (25,70)
40 (25, 70)
PCI Success 95.4 95.2 1.01 (0.95-1.07) 0.83
• Vascular closure devices used in 26% of Femoral group
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Primary and Secondary OutcomesPrimary and Secondary Outcomes
RadialRadial(n=3507)(n=3507)
%%
Femoral Femoral (n=3514)(n=3514)
%%HRHR 95% CI95% CI PP
Primary OutcomeDeath, MI, Stroke, Death, MI, Stroke, Non-CABG Major Non-CABG Major BleedBleed
3.7 4.0 0.92 0.72-1.17 0.50
Secondary OutcomesDeath, MI, Stroke 3.2 3.2 0.98 0.77-1.28 0.90Non-CABG Major Bleeding 0.7 0.9 0.73 0.43-1.23 0.23
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Other OutcomesOther Outcomes
RadialRadial(n=3507)(n=3507)
%%
FemoralFemoral (n=3514)(n=3514)
%%HRHR 95% CI95% CI PP
Major Vascular Access Site Complications
1.4 3.7 0.37 0.27-0.52 <0.0001
TIMI Non-CABG Major Bleeding 0.5 0.5 1.00 0.53-1.89 1.00ACUITY Non-CABG Major Bleeding* 1.9 4.5 0.43 0.32-0.57 <0.000
1
* Post Hoc analysis
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Other OutcomesOther Outcomes
RadialRadial(n=3507)(n=3507)
%%
Femoral Femoral (n=3514)(n=3514)
%%HRHR 95% CI95% CI PP
Death 1.3 1.5 0.86 0.58-1.29 0.47MI 1.7 1.9 0.92 0.65-1.31 0.65Stroke 0.6 0.4 1.43 0.72-2.83 0.30Stent Thrombosis 0.7 1.2 0.63 0.34-1.17 0.14
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R I V A L
Other Outcomes Other Outcomes
RadialRadial(n=3507)(n=3507)
Femoral Femoral (n=3514)(n=3514) P P
Access site Cross-over (%) 7.6 2.0 <0.0001
PCI Procedure duration (min) 35 34 0.62
Fluoroscopy time (min) 9.3 8.0 <0.0001
Persistent pain at access site >2 weeks (%) 2.6 3.1 0.22
Patient prefers assigned access site for next procedure (%)
90 49 <0.0001
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R I V A L
Access Site Major BleedsAccess Site Major Bleeds
*All access site major bleeds actually occurred at femoral arterial site (in radial group due to cross-over or IABP)
HR 0.50 (95% CI 0.19-1.33)
*
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<75 ≥75
FemaleMale
<2525-35>35
≤7070-142.5>142.5
Lowest TertileMiddle TertileHighest Tertile
NSTE-ACSSTEMI
Age
Gender
BMI
Radial PCI Volume/year by Operator
Radial PCI Volume by Centre
Clinical Diagnosis
Overall
0.25 1.00 4.00Radial better Femoral better
Hazard Ratio(95% CI)
0.79
0.36
0.83
0.54
0.021
0.025
Interactionp-value
Death, MI, Stroke or non-CABG major Bleed Subgroups: Primary OutcomeSubgroups: Primary Outcome
R I V A L
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0.25 1.00 4.00 16.00Radial better Femoral better
High MediumLow
High MediumLow
High MediumLow
HighMediumLow
HighMediumLow
0.021
0.013
0.538
0.019
0.003
Interactionp-valueHR (95% CI)
Primary Outcome
Death, MI or stroke
Non CABG Major Bleed
Major Vascular Complications
Access site Cross-over
Results stratified by High*, Medium* and Low*Results stratified by High*, Medium* and Low*Volume radial CentresVolume radial Centres
R I V A L
No significant interaction by Femoral PCI center volume
Tertiles of Radial PCI Centre Volume/yr
*High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)
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NSTE/ACSSTEMI
NSTE/ACSSTEMI
NSTE/ACSSTEMI
NSTE/ACSSTEMI
NSTE/ACSSTEMI
50631958
50631958
50631958
50631958
50631958
3.55.2
2.74.6
0.83.2
1.00.9
3.83.5
3.83.1
3.42.7
1.21.3
0.60.8
1.41.3
0.25 1.00 4.00Radial better Femoral better
Hazard Ratio(95% CI)
0.025
0.011
0.001
0.56
0.89
Interactionp-value2N Radial Femoral
% %
Primary Outcome
Death, MI or stroke
Death
Non CABG Major Bleed
Major Vascular Complications
Outcomes stratified by STEMI vs. NSTEACSOutcomes stratified by STEMI vs. NSTEACSR I V A L
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0.25 1.00 4.00Radial better Femoral better
Odds Ratio(95% CI)
Pre-RIVALRIVALCombined
Pre-RIVALRIVALCombined
Pre-RIVALRIVALCombined
Pre-RIVAL*RIVAL **Combined
0.2 0.7 0.5
0.61.41.0
2.33.22.8
2.8 1.3 2.3
1.2 0.9 1.0
2.5 3.73.1
3.3 3.23.3
4.12.73.5
0.40
0.41
0.72
0.67
Heterogeneityp-value
Radial(%) Femoral(%)
Non-CABG Major Bleeds
Major Vascular Access Complication
Death,MI or Stroke
Death, MI or Stroke (Radial Experts)
Updated Meta-analysis of RCTs Updated Meta-analysis of RCTs
0.002
<0.0001
0.17
0.005
P-value
*Radial Expert Centres defined as centres default approach radial or known expert radial centre ** High volume radial centres (highest tertile)
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R I V A L
ConclusionConclusion No significant difference between radial and femoral access No significant difference between radial and femoral access
in primary outcome of death, MI, stroke or non-CABG major in primary outcome of death, MI, stroke or non-CABG major bleedingbleeding
With radial access compared to femoral, rates of primary With radial access compared to femoral, rates of primary outcome appeared to be lower in high volume radial centres outcome appeared to be lower in high volume radial centres and STEMIand STEMI
Radial had fewer major vascular complications but similar Radial had fewer major vascular complications but similar PCI success PCI success
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ImplicationsImplications
Both radial and femoral approaches are safe and Both radial and femoral approaches are safe and effectiveeffective
Increasing experience may improve outcomes with Increasing experience may improve outcomes with radial accessradial access
Clinicians and patients may choose radial because Clinicians and patients may choose radial because of its similar efficacy and reduced vascular of its similar efficacy and reduced vascular complications complications
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Available Online at Available Online at www.lancet.comwww.lancet.com
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R I V A L
AcknowledgementsAcknowledgementsRIVAL Investigators from 158 sites in 32 countriesRIVAL Investigators from 158 sites in 32 countries
Steering Committee
S.S. Jolly (PI) S.R. Mehta (PI)
S. Yusuf (Chair) C.D. Joyner (Adjudication Chair)
S. Chrolavicius M. Keltai
A. Avezum F. Lanas
A. Budaj B. Lewis
J. Cairns K. Niemela
R. Diaz S.V. Rao
V. Dzavik P. G. Steg
M.G. Franzosi V. ValentinC. B. Granger P. Widimsky
D. Xavier
DMCP. Sleight (Chair)) D. R. Holmes Jr.
J.L. Anderson D.E. Johnstone
D. DeMets
J. Hirsh
Project Office Study Team
S. Chrolavicius (Project Manager)
B. Jedrzejowski (Research Coordinator)
M. Lawrence (Events Adjudication Coordinator)
R. Manojlovic, L. Mastrangelo, E. Pasadyn, C. Agrippa, M. McClelland, (former ) C. Cramp, C. Horsman, A. Robinson, L. Blake, W. Chen, S. Diodato, A. Lehmann, T. Sovereign, L.Wasala
Statisticians and Biometrics
R. Afzal (IDMC-Associated)
P. Gao
L. Xu
X. Yang
E. Dai