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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 l.jpg

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


Disclosures l.jpg
Disclosures coronary intervention in ACS (RIVAL)

Funded by:

  • Sanofi-Aventis and Bristol-Myers Squibb (through CURRENT)

  • Population Health Research Institute

  • Canadian Network and Centre for Trials Internationally (CANNeCTIN, an initiative of Canadian Institutes of Health Research)


Bleeding is associated with death and ischemic events l.jpg
Bleeding is associated with Death and Ischemic Events coronary intervention in ACS (RIVAL)

HR 5.37 (3.97-7.26)

HR 4.44 (3.16-6.24)

HR 6.46 (3.54-11.79)

Eikelboom JW et al. Circulation 2006;114(8):774-82.


Prior meta analysis of 23 rcts of radial vs femoral n 7030 l.jpg
Prior Meta-analysis coronary intervention in ACS (RIVAL)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)

Transradial better

1.0

Transfemoral better

Jolly SS, et al. Am Heart J 2009;157:132-40.


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RIVAL Study Objective coronary intervention in ACS (RIVAL)

- 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


Rival study design l.jpg
RIVAL Study coronary intervention in ACS (RIVAL) 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)

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.


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Study Outcome Definitions coronary intervention in ACS (RIVAL)


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Final Recruitment coronary intervention in ACS (RIVAL)

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.


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Participating Countries coronary intervention in ACS (RIVAL)

North America 1614

Europe 3564

Asia 1117

Middle East/Israel 239

South America 423

Australia and New Zealand 64


Baseline characteristics l.jpg
Baseline Characteristics coronary intervention in ACS (RIVAL)


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Therapies - Initial Hospitalization coronary intervention in ACS (RIVAL)


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Operator Volume coronary intervention in ACS (RIVAL)Procedure Characteristics

  • Vascular closure devices used in 26% of Femoral group


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Primary and Secondary Outcomes coronary intervention in ACS (RIVAL)


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Other Outcomes coronary intervention in ACS (RIVAL)

* Post Hoc analysis


Other outcomes15 l.jpg
Other Outcomes coronary intervention in ACS (RIVAL)

* Post Hoc analysis


Other outcomes16 l.jpg
Other Outcomes coronary intervention in ACS (RIVAL)


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Access Site Major Bleeds coronary intervention in ACS (RIVAL)

HR 0.50 (95% CI 0.19-1.33)

*

*All access site major bleeds actually occurred at femoral arterial site (in radial group due to cross-over or IABP)


Slide18 l.jpg

R I V A L coronary intervention in ACS (RIVAL)

Subgroups: Primary Outcome

Death, MI, Stroke or non-CABG major Bleed

Overall

p-value

Interaction

Age

<75

≥75

0.79

Gender

Female

Male

0.36

BMI

<25

25-35

>35

0.83

Radial PCI Volume/year by Operator

≤70

70-142.5

>142.5

0.54

Radial PCI Volume by Centre

Lowest Tertile

Middle Tertile

0.021

Highest Tertile

Clinical Diagnosis

NSTE-ACS

0.025

STEMI

Radial better Femoral better

0.25

1.00

4.00

Hazard Ratio(95% CI)


Slide19 l.jpg

R I V A L coronary intervention in ACS (RIVAL)

Results stratified by High*, Medium* and Low*

Volume radial Centres

*High (>146 radial PCI/year/ median operator at centre),

Medium (61-146), Low (≤60)

p-value

Tertiles of Radial PCI Centre Volume/yr

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)


Slide20 l.jpg

R I V A L coronary intervention in ACS (RIVAL)

Outcomes stratified by STEMI vs. NSTEACS

% %

Interaction

2N

Radial Femoral

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)


Slide21 l.jpg

Updated Meta-analysis of RCTs coronary intervention in ACS (RIVAL)

Heterogeneity

Radial(%) Femoral(%)

p-value

P-value

Non-CABG Major Bleeds

Pre-RIVAL

0.2

1.2

RIVAL

0.7

0.9

0.40

0.002

Combined

0.5

1.0

Major Vascular Access Complication

Pre-RIVAL

0.6

2.5

RIVAL

1.4

3.7

0.41

<0.0001

Combined

1.0

3.1

Death,MI or Stroke

Pre-RIVAL

2.3

3.3

RIVAL

3.2

3.2

0.72

0.17

Combined

2.8

3.3

Death, MI or Stroke (Radial Experts)

Pre-RIVAL (Radial Expert

Centre trials)*

2.8

4.1

RIVAL(highest radial

PCI centre tertile)

1.3

2.7

0.67

0.005

Combined

2.3

3.5

0.25

1.00

4.00

*Radial Expert Centres defined as centres default approach radial or known expert radial centre

Radial better Femoral better

Hazard Ratio(95% CI)


Conclusion l.jpg
Conclusion coronary intervention in ACS (RIVAL)

  • No significant difference in primary outcome of death, MI, stroke or non-CABG major bleeding

  • Rates of Primary outcome appeared to be lower in Radial group in high volume radial centres and STEMI

  • Radial had fewer major vascular complications but similar PCI success


Implications l.jpg
Implications coronary intervention in ACS (RIVAL)

  • Both radial and femoral approaches are safe and effective

  • The reduction in vascular complications may be a reason to use radial

  • With increasing experience the radial approach may be associated with better outcomes


Acknowledgements l.jpg
Acknowledgements coronary intervention in ACS (RIVAL)

RIVAL Program Investigators from 158 sites in 32 countries