1. Why Radial Access Should be the Default for Women undergoing PCI?
Sanjit Jolly MD, FRCP
Interventional Cardiologist, Hamilton Health Sciences, McMaster University,
Hamilton, Canada

2. Sanjit S. Jolly, MD
Grant Support or Honoraria: Medtronic, Bristol Myers Squibb, Sanofi-Aventis, GlaxoSmithKline

3. Female gender and access site complications
Ahmed B, et. al. Circulation 2009

4. Radial approach in women Data from 593,000 procedures in NCDR CathPCI
Femoral approach as the reference
Rao SV, et. al. JACC Intv 2008

5. Rates of Radial Approach in Women Over Time N=2
Rates of Radial Approach in Women Over Time N=2.2 million procedures in CathPCI
Feldman D, et. al. AHA 2012

6. RIVAL Study Design Primary Outcome: Death, MI, stroke
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:

7. 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
Major Vascular Access Site Complications
Large hematoma
Pseudoaneurysm requiring closure
AV fistula
Other vascular surgery related to the access site

8. 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 ( )
0.83
Vascular closure devices used in 26% of Femoral group

9. 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
0.50
Secondary Outcomes
Death, MI, Stroke
3.2
0.98
0.90
Non-CABG Major Bleeding
0.7
0.9
0.73
0.23

10. Other Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P
Major Vascular Access Site Complications
1.4
3.7
0.37
<0.0001
Other Definitions of Major Bleeding
TIMI Non-CABG Major Bleeding
0.5
1.00
ACUITY Non-CABG Major Bleeding*
1.9
4.5
0.43
* Post Hoc analysis

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

12. 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
Persistent pain at access site >2 weeks (%)
2.6
3.1
0.22
Patient prefers assigned access site for next procedure (%) 90 49
Symptomatic radial occlusion requiring medical attention 0.2% in radial group

13. Non CABG major bleeding by actual access site used to complete procedure (not intent to treat)*
*Post Hoc analysis

14. Subgroups: Primary Outcome
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
Male
0.356
BMI
<25
25-35
0.637
>35
Radial PCI Volume by Operator
≤70
>142.5
0.536
Radial PCI Volume by Centre
Lowest Tertile
Middle Tertile
Highest Tertile
0.021
Diagnosis at presentation
NSTE-ACS
STEMI
0.025
0.25
1.00
4.00
Radial better Femoral better
Hazard Ratio (95% CI)

15. High*, Medium* and Low* Volume Radial Centres
Results stratified by
High*, Medium* and Low* Volume Radial Centres
R I V A L
*High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≤60)
Tertiles of Radial PCI Centre Volume/yr
HR (95% CI)
p-value
Primary Outcome
Interaction
High
0.021
Medium
Low
Death, MI or stroke
High
0.013
Medium
Low
Non CABG Major Bleed
High
Medium
0.538
Low
Major Vascular Complications
Of note in high volume femoral PCI centres, femoral was not better than radial.
High
0.019
Medium
Low
Access site Cross-over
High
0.003
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)

16. Major Vascular Complications in RIVAL

17. Specific Challenges in Women for TRA
Smaller radial diameter/ Higher rates of Spasm
Greater Expertise needed
Need proficiency with 5 Fr PCI

18. Implications Operators should learn and practice radial access
Women at higher risk of bleeding and so should not be denied TRA

19. Radial Access Now Class IIa indication in ACC guidelines
PCI inHosptals Without On-Sie Surgical Backup I
IIa
IIb
III A
Level of Evidence of A
2011 ACCF/AHA/SCAI Guideline for PCI. JACC. 2011; 58:e 19

20. 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
N=1800 pts, 65 sites
Sites from NCRI
Patent hemostasis required
Vascular closure devices allowed
Radial
Femoral
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