Transradial approach versus femoral approach for primary percutaneous coronary intervention (PCI)

1. TRA vs TFA
for primary PCI
Dr. Stefano Rigattieri
Interventional Cardiology
Sandro Pertini Hospital
Rome, ITALY

2. Disclosures
• Speaking fees from AstraZeneca, Pfizer and
Correvio.

3. Benefit and risks of TRI in STEMI
Benefits:
• Less access site bleeding
• Ability to anticoagulate
more aggressively (?)
• Earlier ambulation
• Patient comfort
Risks:
• Longer procedures
• More contrast
• Longer fluoro times
• Longer door-to-balloon
times for STEMI
Reproduced by Yeh

4. Overview
• Access-site bleeding and outcome
– Is reduction of access-site bleeding really
important?
• TRA and DTB time
– Is TRA delaying reperfusion?
• Alternative bleeding avoidance strategies
– Do we really need TRA?
• «Pleiotropic» effects of TRA

5. Access site bleeding and
outcome

6. Bleeding in SCAD, STEMI & NSTEMI
SCAD
(Overall rate=2.1%)
70%
30%
NSTEMI
(Overall rate=4.8%)
30%
70%
STEMI
(Overall rate=12.7%)
NCDR Cath PCI registry
45%
55%
Rao et al. JACC 2010
Non-access site
Access site

7. Access-site bleedings in primary PCI
Karrowni et al., JACC Intv 2013
2.0%
5.6%

8. Verheugt et al. JACC Intv 2011

9. Kikkert WJ, JACC 2014
2002 STEMI patients undergoing primary PCI
BLEEDING SITE AND LONG-TERM MORTALITY

10. Evidence from RCT comparing
TRA vs TFA

11. Pooled evidence from RCT
Major bleeding
Karrowni et al., JACC Intv 2013

12. Pooled evidence from RCT
All-cause mortality
Karrowni et al., JACC Intv 2013

13. RIVAL
(STEMI)
RIFLE-STEACS STEMI-RADIAL
Patients N. 1958 1001 707
Major bleeding
(%, R vs F)
0.84 vs 0.91
p=0.87 *
7.8%/12.2%
p=0.03
1.4%/11.0%
p<0.01
MACE
(%, R vs F)
2,62 vs 4,59
p=0.03 #
7.2%/11.4%
p=0.03
3.5%/4.2%
p=0.7
Mortality
(%, R vs F)
1.26 vs 3.19
p<0.01 #
5.2%/9.2%
p=0.02
2.3%/3.1%
p=0.64
GPI
(R/F)
34.5/31.1 67.4%/69.9% 45%/45%
Bivalirudin
(R/F)
2.3/4.1 8.0%/7.2% 0%/0%
UFH IU/Kg
(R/F)
NA 70/71 103/105
* Pint=ns # Pint<0.05

15. RIVAL
(STEMI)
RIFLE-STEACS STEMI-RADIAL MATRIX
(STEMI)
Patients N. 1958 1001 707 4010
Major bleeding
(%, R vs F)
0.84 vs 0.91
p=0.87 *
7.8%/12.2%
p=0.03
1.4%/11.0%
p<0.01
1.8%/2.9%
p=0.02 *
MACE
(%, R vs F)
2,62 vs 4,59
p=0.03 #
7.2%/11.4%
p=0.03
3.5%/4.2%
p=0.7
6.0%/6.3%
p=0.77 *
Mortality
(%, R vs F)
1.26 vs 3.19
p<0.01 #
5.2%/9.2%
p=0.02
2.3%/3.1%
p=0.64
2.4%/2.74%
p=0.49 *
GPI
(R/F)
34.5/31.1 67.4%/69.9% 45%/45% NA
13.9%/12.6% §
Bivalirudin
(R/F)
2.3/4.1 8.0%/7.2% 0%/0% NA
40.2%/40.7% §
UFH IU/Kg
(R/F)
NA 70/71 103/105 NA
* Pint=ns # Pint<0.05 § overall study population

16. -0.07
-4.4
-9.6
-1.1
-1.97
-4.2
-0.7
-0.3
-1.93
-4
-0.8
-0.34
-10
-8
-6
-4
-2
0
2
Absolutedifferencesinend-points
Radilal-femoral(%)
major bleeding MACE mortality
RIVAL*
RIFLE-STEACS
STEMI-RADIAL
MATRIX*
* STEMI subgroup
The complex interplay between major
bleeding and MACE

17. Nested case-control study on all-cause
mortality and bleeding
Valgimigli et al. Lancet 2015
Factors associated with deaths at 30 days
non directly attributed to a bleeding events

18. Major bleeding
Pooled evidence from RCT (updated)

19. Pooled evidence from RCT (updated)
All-cause mortality

20. Data from registries

21. 0.5
1.0
2.0
Bleeding, adjusted
Bleeding
Procedure success, adjusted
Procedure success
Mortality, adjusted
Mortality
CathPCI Registry
Baklanov et al. JACC 2013
Favors radial Favors femoral
294,769 STEMI pts. 2007-2011
RR (95% CI)

22. BCIS
End-point HR (95% CI) p
30-day mortality 0.71 (0.52-0.97) <0.05
In-hospital MACCE 0.73 (0.57-0.93) <0.05
Major bleeding 0.37 (0.18-0.74) <0.01
Access-site
complications
0.38 (0.19-0.75) <0.01
Mamas et al. JACC Intv 2013
46,128 STEMI pts. 2007-2011

23. SCAAR
25,374 STEMI pts. 2005-2010
Olivecrona et al. EuroPCR
End-point OR adj (95% CI) p
30-day mortality 0.57 (0.46-0.72) <0.001
1-year mortality 0.78 (0.64-0.96) 0.018
Any reported
bleeding event
0.43 (0.31-0.61) <0.001
Serious bleeding
event
0.43 (0.32-0.57) <0.001

24. ALKK
Bauer et al. CCI 2015
17,685 STEMI pts. 2008-2012

25. TRA and D2B time

26. D2B and cross-over rate
RIFLE-STEACS STEMI-RADIAL
Radial Femoral p Radial Femoral p
DTB (min) 60 (35-99) 53 (31-91) 0.175 NS
Cross-over
(%)
9.6% 2.8% <0.001 3.7% 0.6% 0.003
Fluoro
time (min)
7.9 ± 4.7 8.0 ± 5.5 0.76
High-volume experienced centers
proficient in both access sites
All participating interventional cardiologists
were high-volume operators (150 PCIs/year)
and had adequate expertise in both
approaches, meeting minimal proficiency
criteria of 50% interventional cases by radial
approach per year.

27. Time delay and mortality in primary
angioplasty: every minute counts
De Luca et al. Circulation 2004

28. D2B TIME AND MORTALITY:
NCDR 2005-2009
Menees et al. NEJM 2013

29. DTB time according to vascular access
Karrowni et al., JACC Intv 2013

30. Is TRI-related delay acceptable?
Based on:
• Pooled 30-day mortality rate from RIVAL (STEMI subgroup) and RIFLE-STEACS
• NCDR DTB analysis
Wimmer et al. Am Heart J 2014

31. Alternative bleeding avoidance
strategies

32. ACUITY investigators, Circ Cardiovasc Interv 2010

33. *
*NCDR CathPCI bleeding risk model

34. VCD meta-analysis
Outcome Studies Participants Incidence VCDs
versus control
Effect estimate
(RR, 95%CI)
Groin hematoma 14 2656 5.3% vs 5.2% 1.01 (0.74-1.38)
Groin bleeding 8 2160 4.0% vs 0.9% 3.49 (0.62-19.8)
Pseudoaneurysm 16 4106 0.7% vs 1.1% 0.69 (0.38-1.23)
Lower limb
ischemia/arterial
stenosis/device
entrapment
11 2567 0.3% vs 0% 3.07 (0.50-18.83)
Groin infection 11 3686 0.2% vs 0.06% 2.56 (0.50-13.10)
Blood transfusion 12 2957 0.7% vs 0.8% 0.78 (0.35-1.71)
Vascular surgery 17 4337 0.6% vs 0.3% 1.76 (0.74-4.20)
Time to
hemostasis
5 889 - -42.90 (-55.26-
30.53)
Biancari et al. Am Heart J 2010

35. ISAR-CLOSURE
VCD
(n= 3015)
Manual compression
(n=1509)
p
Vascular access-site complications
(1° EP)
6.9% 7.9% <0.001 non-inf
0.23 superiority
Access site-related major bleedings 0.1 0.2 0.39
Hematoma >5 cm 4.8 6.8 0.006
Time to hemostasis (min) 1 (0.5-2.0) 10 (10-15) <0.001
Intravascular (FemoSeal) or extravascular (Exoseal) closure devices versus
manual compression in patients undergoing diagnostic cath through CFA
Schulz-Schüpke et al., JAMA 2014

36. TRA vs FemoSeal in primary PCI
Radial (n=229) FemoSeal (n=229) p
MACCE
Death (n,%) 4 (1.7) 3 (1.3) 0.5
Myocardial infarction (n,%) 5 (2.2) 1 (0.4) 0.108
Target vessel failure (n,%) 6 (2.6) 1 (0.4) 0.061
Stent thrombosis (n,%) 5 (2.2) 1 (0.4) 0.108
TIA/stroke (n,%) 0 (0) 2 (0.9) 0.249
Hierarchical MACCE (%) 10 (4.4) 6 (2.6) 0.223
TIMI bleedings
- Overall (n,%) 3 (1.3) 15 (6.6) 0.003
- Major (n,%) 0 (0) 6 (2.6) 0.015
- Minor (n,%) 3 (1.3) 9 (3.9) 0.141
Alonzo et al. CCI 2015

37. TRA vs FemoSeal in primary PCI
1,3% 6,6% p<0,05

38. Rigattieri et al. TCT 2015
Access-site complications
TRA vs VCD

39. TRA vs VCD
Rigattieri et al. TCT 2015
Major bleedings

40. ARISE RCT
Non-ST segment elevation acute coronary syndrome patient
with an intended invasive strategy
N=200
Randomization 1:1
Primary end-point:
access site complications @ 30 days
AngioSeal versus Radial Approach In Acute Coronary SyndromE
Radial approach
TR band™
Femoral approach
AngioSeal™
de Andrade et al. Trials 2013

41. MATRIX Antithrombin RCT
Valgimigli et al. NEJM 2015

42. MATRIX Antithrombin RCT

43. SAFARI-STEMI RCT
The safety and efficacy of femoral access versus radial access
for primary PCI in STEMI
2770 pts with STEMI with symptoms onset <12 h
1:1
TRA + bivalirudin TFA + bivalirudin
Primary outcome:
NACE (Death, reMI,
stroke or TIMI bleed)

44. «Pleiotropic» effects of TRA:
less harm to the kidneys?

45. Chronic kidney injury after cath/PCI
BCCR Registry; 69214 pts 1999-2005
Vuurmans et al. Heart 2010

46. p=0.007
Cortese et al. Am J Cardiol 2014
Risk of acute kidney injury after
primary PCI: the PRIPITENA registry
450 propensity score-matched STEMI patients

47. Experience and training are key
factors

48. RIVAL
Prespecified subgroup analysis of the primary outcome
according to radial PCI volume by Centre
Jolly et al. Lancet 2011

49. Proposed framework for learning steps
and competency levels for TRI
Hamon et al. EuroIntervention 2013

50. ..in the next future..