1. Prof. Yasser Baghdady, MD Professor of Cardiology Cairo University
Why Change to Radial?
Prof. Yasser Baghdady, MD
Professor of Cardiology
Cairo University

2. Author Disclosure Information
Financial disclosure
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3. In Medicine We argue a lot…
Always debating….
PCI vs Surgery
Medical treatment vs PCI
So inevitably we come to the question?
Radial vs Femoral

4. A few years back…. We had little to argue about….
Femoral approach was well established
The default in most interventional procedures
Radial approach was used as a “bail out”

5. Conditions mandating Radial Access

6. Do we need to change?
Do we have enough evidence of radial first, femoral as a “bail out”
Or rather concept is not radial instead of femoral but rather radial as a “default”

7. When do we need to change?
If radial approach is safer than femoral approach (safest should be the default)
If radial approach is at least as efficacious as the femoral

8. Why Femoral?

9. The argument for the “femoral” approach
The “3” distinct steps for radial approach:
Arterial Access
Negotiating the catheter into the ascending aorta
Intubating the coronary arteries
More:
Difficult
Time consuming
Fail or be inadequate

10. The argument for the “femoral” approach
Once the coronaries are engaged, the quality of the procedure is more likely to be compromised by inadequate support or visualization.

11. The argument for the “femoral” approach
With proper training and experience (radial approach), most of these obstacles can be avoided.
However,
Larger learning curve
A significant percentage of practitioners (esp. in low volume centres) may never reach the plateau of equivalency with the femoral approach.

13. The argument for the “femoral” approach
Flexibility in terms of catheter sizes and procedures inherent in access to a large vessel are usually not available.
Longer time and greater radiation exposure for the patient and the operator.

14. The argument for the “femoral” approach
RIVAL Trial: Access site failure

15. Cross Over and Procedural Success Rates
94.1% of radial and 97.4% of femoral cohorts received respective treatment as allocated
In 5.8% of radial and 2.3% of TF cohort the allocated access was attempted but failed.
In 3 (0.1%) in the radial and 13 (0.3%) patients in the femoral groups the allocated access was not attempted %
P<0.001
P=0.77 *
*: TIMI <3 and/or % final stenosis >30%

16. Why Radial?

17. Risks and Complications of PCI
PCI risk includes:
Peri-procedural myocardial infarction
Stent thrombosis
Stroke
Vascular complications especially bleeding
Mortality

18. Risk of Complications Related to
Underlying patient characteristics
Anti-thrombotic therapy used
Integrity of the arteriotomy
Method of post-procedure haemostasis
Clinical status: elective or emergency procedures

19. Among patients undergoing PCI
30-70% of bleeding complications are related to the vascular access

20. So what?
Across the spectrum of clinical risk, post-procedural bleeding and vascular complications were considered minor.
Now, multiple studies have shown significant association between bleeding and subsequent morbidity and mortality.

21. Bleeding is associated with Death and Ischemic Events
HR 5.37 ( )
N=34,146
OASIS Registry,
OASIS 2, CURE trials
HR 4.44 ( )
Change colors
HR 6.46 ( )
Eikelboom JW et al. Circulation 2006;114(8):

22. Risk of Bleeding 26000 patients with ACS
As bleeding increases, stepwise increase in
risk of 30 day mortality,
30 day death or MI
6 months mortality
Rao et al: Impact of bleeding severity on clincal outcomes among patients
With acute coronary syndromes. Am J Cardiol 2005;96:

23. 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

24. Risk of Bleeding Not only MI and Mortality
Bleeding increases:
Stroke
Stent thrombosis
Blood transfusions which by themselves increase mortality
Length of hospital stay and cost ($70 million in US, extra cost of bleeding)

25. So this is the reason
For
Why Radial..

26. Meta-analysis of 23 RCTs of Radial vs. Femoral (N=7030)
Radial better
Femoral better
1.0
PCI Procedure Failure
Death
Death, MI or stroke
Major bleeding
1.31 ( )
0.74 ( )
0.71 ( )
0.27 ( )
Jolly SS, et al. Am Heart J 2009;157:

27. Radial approach and Complex PCI
Radial artery readily accommodates 6F and sheathless 7F techniques: no limitations to performing complex PCI (incl. LM, CTO)

28. So why does a radial approach decrease bleeding and vascular complications?
Radial artery compared to femoral:
More superficial
Smaller in caliber
Lacks any important adjacent structures or potential spaces (e.g. retroperitoneal space)
Easily compressible

29. A randomized comparison of RadIal Vs
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

30. 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:

31. 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

32. 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

33. Other Outcomes Radial (n=3507) % Femoral (n=3514) % HR 95% CI P Death
1.3
1.5
0.86
0.47 MI
1.7
1.9
0.92
0.65
Stroke
0.6
0.4
1.43
0.30
Stent Thrombosis
0.7
1.2
0.63
0.14

34. 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

35. ACUITY TRIAL
EuroIntervention May;5(1):
Choice of arterial access site and outcomes in patients with acute coronary syndromes managed with an early invasive strategy: the ACUITY trial.
Hamon M1, Rasmussen LH, Manoukian SV, Cequier A, Lincoff MA, Rupprecht HJ, Gersh BJ, Mann T, Bertrand ME, Mehran R, Stone GW.

36. ACUITY TRIAL 13K + pts CONCLUSIONS:
Transradial compared to femoral arterial access is associated with similar rates of composite ischaemia and with fewer major bleeding complications in patients with ACS managed invasively.

37. Results From The Minimizing Adverse Haemorrhagic Events By Transradial Access Site And Systemic Implementation
of Angiox-MATRIX
Access Program
M. Valgimigli, MD, PhD
Erasmus MC
Rotterdam, The Netherlands
on behalf of the MATRIX Group
NCT

38. NSTEACS or STEMI with invasive management
MATRIX Access
NSTEACS or STEMI with invasive management
Aspirin+P2Y12 blocker
8,404 patients with ACS undergoing coronary angiography ± PCI from 11th Oct 2011 to 7th Nov 2014
1:1
Trans-Radial Access
Trans-Femoral Access
Q: Is TRI superior to TFI ?
1:1
Bivalirudin
Mono-Tx
Heparin
±GPI
MATRIX Access) was a randomised, multicentre, superiority trial comparing transradial
against transfemoral access in patients with percutaneous coronary intervention
with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous
coronary intervention, if indicated
1:1
Stop
Infusion
Prolong≥ 6 hs
infusion
MATRIX Program registered at
ClinicalTrials.gov, number NCT
Am Heart J Dec;168(6): e6.

39. MI and CVA endpoints: Any MI, STEMI, NSTEMI, unclassified
MI and CVA endpoints: Any MI, STEMI, NSTEMI, unclassified*, stroke, TIA
*: LBBB, paced rhythm or unavailability of interpretable ECG
P=0.20
P=1.00 % %
P=0.059
When looking into the individual components of both coprimary endpoints, overall MI or stroke or type thereof did not differ in the radial vs femoral group

40. Fatal and ST EPs: All-Cause, Cardiac, non-CV mortality, type of stent thrombosis
RR:0.72
( )
P=0.045 %
RR: 0.75
( )
P=0.08
P=0.69 %
NNTB: 167

41. Bleeding endpoints: BARC, TIMI, GUSTO, access vs non-access related
RR: 0.64 %
P=0.20
RR: 0.78
P=0.08
RR: 0.72
P=0.0004
RR: 0.37
2.5%
P=0.68
P=0.013
RR: 0.67
1.4%
P=0.82
BARC 3 or 5
Major
or minor
moderate
or severe

42. MATRIX: Radial PCI Reduces Major Bleeding, All-Cause Mortality in ACS Patients

43. STEMI RADIAL TRIAL

44. RIFLE STEACS (Radial Versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome)
1001 patients randomly assigned to TRA or TFA
No difference in total ischaemic time, use GP IIb/IIIa inhibitors, thrombus aspiration or final TIMI flow

45. RIFLE STEACS

46. From: Radial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) Study
J Am Coll Cardiol. 2012;60(24): doi: /j.jacc
Figure Legend:
Net adverse cardiac event (NACE) is the composite of cardiac death, myocardial infarction, target lesion revascularization, stroke, and bleeding.
Date of download: 8/28/2016
Copyright © The American College of Cardiology. All rights reserved.

47. We now have…..
Bleeding
All cause mortality

48. Radial Approach and Patient Preference
Patient Preference: Overwhelming

50. Summarize

51. Comparing Femoral & Radial Access

52. So even if you are not experienced…

54. Conclusion
Deciding between 2 therapeutic strategies involves weighing the risks and benefits of each.

55. Conclusion
If we take into account NNT for radial vs femoral access to prevent:
One major attack of Bleeding: 1/68
Death: 1/136 to 1/167

56. Conclusion
The bulk of evidence calls for radial access as the default access site.
Femoral access should be used as a bailout strategy
Compared with femoral the radial approach is:
Safer
Preferred by patients
Associated with reduced mortality esp. in acute coronary syndrome.
Lower hospital costs

57. ESC guidelines
Radial Access for ACS: 1a recommendation