Why Radial Access Should be the Default for Women undergoing PCI?
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Transcript of Why Radial Access Should be the Default for Women undergoing PCI?
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Why Radial Access Should be
the Default for Women
undergoing PCI?
Sanjit Jolly MD, FRCP
Interventional Cardiologist, Hamilton Health
Sciences, McMaster University,
Hamilton, Canada
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R I V A L
Female gender and access site
complications
Ahmed B, et. al. Circulation 2009
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R I V A L
Radial approach in womenData from 593,000 procedures in NCDR CathPCI
N=201,652 Women
Femoral approach as the reference
Rao SV, et. al. JACC Intv 2008
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Rates of Radial Approach in Women Over TimeN=2.2 million procedures in CathPCI 2007-2011
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% R
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Females Males
Feldman D, et. al. AHA 2012
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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 Study 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.
Blinded Adjudication of Outcomes
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R I V A L
Definitions
Major Bleeding (CURRENT/OASIS 7)
• Fatal
• > 2 units of Blood transfusion
• Hypotension requiring inotropes
• Leading to hemoglobin drop of ≥ 5 g/dl
• Requiring surgical intervention
• ICH or Intraocular bleeding leading to significant vision loss
MajorVascular 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
Operator Volume
Procedure Characteristics
Radial (n=3507)
Femoral (n=3514)
HR (95% CI)P
value
Operator 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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R I V A L
Primary and Secondary Outcomes
Radial(n=3507)
%
Femoral (n=3514)
%HR 95% CI P
Primary Outcome
Death, MI, Stroke, Non-CABG Major Bleed
3.7 4.0 0.92 0.72-1.17 0.50
Secondary Outcomes
Death, MI, Stroke 3.2 3.2 0.98 0.77-1.28 0.90
Non-CABG Major Bleeding
0.7 0.9 0.73 0.43-1.23 0.23
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R I V A L
Other Outcomes
Radial(n=3507)
%
Femoral(n=3514)
%HR 95% CI P
Major Vascular Access Site Complications
1.4 3.7 0.37 0.27-0.52 <0.0001
Other Definitions of Major Bleeding
TIMI Non-CABG Major Bleeding
0.5 0.5 1.00 0.53-1.89 1.00
ACUITY Non-CABG Major Bleeding*
1.9 4.5 0.43 0.32-0.57 <0.0001
* Post Hoc analysis
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R I V A L
Site of Non-CABG Major Bleeds
(RIVAL definition)
*Sites of Non Access site Bleed: Gastrointestinal (most common
site), ICH, Pericardial Tamponade and Other
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R I V A L
Other Outcomes
Radial(n=3507)
Femoral (n=3514)
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
• Symptomatic radial occlusion requiring medical attention 0.2% in radial group
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R I V A L
Non CABG major bleeding by actual access site used to complete
procedure (not intent to treat)*
*Post Hoc analysis
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Death, MI, Stroke or non-CABG major Bleed
Subgroups: Primary OutcomeR I V A L
0.251.00 4.00
Radial better Femoral better
Hazard Ratio (95% CI)
<75≥75
FemaleMale
<2525-35>35
≤70
70-142.5>142.5
Lowest TertileMiddle TertileHighest Tertile
NSTE-ACSSTEMI
Age
Gender
BMI
Radial PCI Volume by Operator
Radial PCI Volume by Centre
Diagnosis at presentation
Overall
0.786
0.356
0.637
0.536
0.021
0.025
Interactionp-value
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0.25 1.00 4.00 16.00
Radial better Femoral better
High MediumLow
High MediumLow
High MediumLow
HighMediumLow
High
MediumLow
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* Volume 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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R I V A L
Major Vascular
Complications in RIVAL
3.2%
0.8%
6.1%
2.8%
Female Male
Radial Femoral
P=0.004P<0.001
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R I V A L
Specific Challenges in Women
for TRA
Smaller radial diameter/ Higher rates
of Spasm
Greater Expertise needed
Need proficiency with 5 Fr PCI
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R I V A L
Implications
Operators should learn and practice
radial access
Women at higher risk of bleeding and
so should not be denied TRA
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Radial Access Now Class IIa
indication in ACC guidelines
I IIa IIb III
2011 ACCF/AHA/SCAI Guideline for PCI. JACC. 2011; 58:e44-122.
• Level of Evidence of A
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Study of Access site For Enhancing PCI for Women (SAFE-
PCI for Women)*
Female patient undergoing urgent or elective PCI
Best background medical therapy
Bivalirudin, Clopidogrel, Prasugrel
2b3a at investigator’s discretion
Radial Femoral
N=1800 pts, 65 sites
Sites from NCRI
Patent hemostasis required
Vascular closure devices allowed
Primary Efficacy Endpoint: BARC Types 2, 3, or 5 bleeding or Vascular
Complications requiring surgical intervention
Primary Feasibility Endpoint: Procedural failure
Secondary endpoints: Procedure duration, total radiation dose, total contrast
volume
*Planned in collaboration with ACC, CSRC, FDA Office of Women’s Health