Transradial Access is the Best Access for Percutaneous Coronary Intervention in Acute Coronary Syndrome with ST Elevation: Results from the RIVAL Trial, SCAAR Registry and Czech NRKI Registry

1. Rencontres Interventionnelles - Transradial Approach
Prague, Czech Republic,
Thursday 29th & Friday 30th September 2011
TRA is the best access for PCI in ACS
with ST elevation: results from the RIVAL trial,
SCAAR registry and Czech NRKI registry
Michael ZELIZKO
IKEM, PRAGUE

2. STEMI and TRA: historical studies
TRA: less bleeding, shorter lenght of stay, higher access failure
Studies: small or non randomized, most cases by single physician.
Vorobcsuk A. et al, Am Heart J 2009;158:814-21

3. RIVAL trial: radial vs femoral access for coronary
angiography and intervention in pts. with ACS

4. RIVAL trial
99,8% coronary angiogram, 66% PCI, 8,5% CABG

5. RIVAL trial

6. RIVAL trial

7. RIVAL trial: subgroup analysis

8. RIVAL trial: STEMI vs NSTEACS subanalysis

9. RIVAL trial summary

10. SCAAR registry:
transradial PCI cuts mortality in STEMI
End point TFA TRA Adjusted OR p
30-day mortality 4,4% 3,2% 0,57 0,001
One-year mortality 7,3% 6,2% 0,78 0,018
Serious bleeding 2,2% 1% 0,43 0,001
Hospital stay /days/ 5,2 4,8 - 0,001
SCAAR registry
STEMI procedures between 2005-2010, n=25 374 pts,
Pts with prior CABG, cardiogenic shock, IABP, warfarin were excluded
final study cohort 21 339 pts
TRA increased from12% to 50%
Comments:
Bivalirudin use higher in TRA
Pts with crossover from TRA to TFA excluded from analysis

11. NRKI – National (Czech) registry for cardiovascular
interventions (analysis 2005 – 2009)
NRKI
Interventions (N=99 065) Patients (N=86 554)
Lesions (N=137 876)
All records of PCI 2005-2009
N=99 065 (100.0%)
N=60 (0.1%) Incomplete date of PCI or death
N=127 (0.1%) Duplicate records
Records from 3 hospitals with incomplete
N=4 476 (4.5%)
records in 2008 and 2009
Records with missing entry of essential
N=6 098 (6.2%)
items about PCI
Records with missing entry of essential
N=379 (0.4%)
items about treatment of lesions
Complete records of PCI
2005-2009
N=87 925 (88.8%)

12. Primary PCI in STEMI (1/2005-12/2009):
TRA (n=2060) and TFA (n=19457)
TFA TRA Others Number of PCI TRA and TFA in TRA and TFA in
0 1000 2000 3000 4000 5000
2005 - 2009 2008 and 2009
(without cardiogenic shocks)
2005 N=92 N=3781
N=3887 N=14 18.6
9.9
%
For patients
%
with STEMI
2006 N=4220
N=166
N=4401 N=15
N=20 162
2007 N=4053
N=346
N=4408 N=9
2008 N=3439
N=456
N=3899 N=4 81.4
90.1 %
2009 N=2630 %
N=929
N=3567 N=8
Number of PCI
0 1000 2000 3000 4000 5000 TRA and TFA in TRA and TFA in
2005 - 2009 2008 and 2009
N=4018
2005 N=97
N=4131 N=16
17.9
For patients
with STEMI
9.6
N=4483 %
2006 N=173 %
N=21 517
N=4671 N=15
N=4375
2007 N=369
N=4753 N=9
N=3685
2008 N=467
N=4159 N=7
82.1
90.4
N=2836 %
2009 N=958 %
N=3803 N=9

13. Cardiogenic shock (before PCI) in STEMI:
TRA (3.6% patients) and TFA (6.5% patients)
Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
(N=20112) without cardiogenic shocks (N=1349) with cardiogenic shocks
5.6%
9.9%
TFA TRA
90.1 94.4
% %
Mortality at 30th day (%) Mortality at 30th day (%)
0% 10% 20% 30% 40% 50% 0% 10% 20% 30% 40% 50%
N=18123 5 .0 % N=1274 4 7 .8 %
N=1989 2 .8 % N=75 3 3 .3 %

14. Age and gender of patients
no difference between TRA vs TFA
Patients with TFA or TRA and STEMI Patients with TFA or TRA
(N=20112) without cardiogenic shocks Number of patients and STEMI (N=21461) Number of patients
0 5000 10000 15000 0 5000 10000 15000
N=12630 TFA N=13492
Men N=1417 Men N=1466
TRA
N=5493 N=5905
Women N=572
Women N=598
>90 >90
80-90 80-90
Age of patients
Age of patients
70-80 70-80
60-70 60-70
50-60 50-60
40-50 40-50
<40 <40
800 600 400 200 0 200 800 600 400 200 0 200
Number of patients Number of patients
Age Age
Total Men Women Total Men Women
Mean ± SD Mean ± SD
Total 63.6 ± 12.1 61.1 ± 11.5 69.2 ± 11.6 Total 63.8 ± 12.1 61.3 ± 11.5 69.5 ± 11.5
Femoral 63.6 ± 12.1 61.1 ± 11.5 69.4 ± 11.5 Femoral 62.8 ± 12.1 61.0 ± 11.6 67.3 ± 12.3
Radial 62.7 ± 12.1 60.9 ± 11.6 67.1 ± 12.2 Radial 63.7 ± 12.1 61.3 ± 11.5 69.3 ± 11.6
p1 0.001* 0.528 <0.001* p1 <0.001* 0.228 <0.001*
1 statistical significance of Kruskal-Wallis test
*statistically significant

15. TRA patients – better LVEF, less 3VD, less LMCA and
bypass as IRA and compared to TFA
Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
TFA without cardiogenic shock (N=20112)
0% 20% 40% 60% 80% 100% 0% 20%
(N=21461)
40% 60% 80% 100%
Anamnesis
TRA
1 5 .0 % 1 6 .0 %
IM 1 5 .0 % 1 5 .0 %
1 9 .0 % 1 9 .0 %
DM 1 9 .0 % 1 9 .0 %
5 .0 % 5 .0 %
CMP 5 .0 % 5 .0 %
2 .0 % 2 .0 %
CABG 1 .0 % * 1 .0 % *
9 .0 % 9 .0 %
previous PCI 9 .0 % 9 .0 %
Diseased vessel
3 .0 % 3 .0 %
Stem ACS 3 .0 % 3 .0 %
4 2 .0 % 4 1 .0 %
1VD 4 3 .0 % 4 1 .0 %
3 0 .0 % 3 0 .0 %
2VD 3 4 .0 % * 3 4 .0 % *
2 6 .0 % 2 8 .0 %
3VD 2 2 .0 % * 2 3 .0 % *
Ejection fraction
2 0 .0 % 1 9 .0 %
> 50% 2 4 .0 % * 2 3 .0 % *
2 1 .0 % 2 0 .0 %
30-50% 1 5 .0 % * 1 6 .0 % *
3 .0 % 4 .0 %
<30% 2 .0 % * 2 .0 % *
Character of operation
8 2 .0 % 8 2 .0 %
Emergent 8 7 .0 % * *
8 6 .0 %
0 .0 % 1 7 .0 %
Elective 0 .0 % 1 4 .0 % *
1 7 .0 % 0 .0 %
Ad hoc 1 3 .0 % * 0 .0 %
Segment
1 .0 % 2 .0 %
LMCA 0 .0 % 1 .0 % *
4 4 .4 %
RIA - RD 4 3 .4 %
4 4 .8 %
4 3 .7 %
1 6 .3 % 1 6 .7 %
RC - RMS 1 6 .6 % 1 7 .0 %
* Statistically significant 4 2 .7 %
difference between TFA ACD 4 3 .1 %
4 2 .1 %
4 3 .1 %
and TRA; tested by 0 .9 %
Fisher’s exact test Bypass 0 .3 % *
0 .9 %
0 .3 % *

16. TRA patients – more frequent use of GPI, DES and
thromboaspiration, but less IABP compared to TFA
Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
TFA without cardiogenic shock (N=20112) (N=21461)
Type of lesion 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100%
A
TRA
3 .0 % 3 .0 %
3 .0 % 3 .0 %
B1 1 7 .0 %
1 7 .0 %
1 7 .0 %
1 7 .0 %
B2 4 0 .0 %
3 6 .0 % *
4 0 .0 %
3 6 .0 % *
C 4 7 .0 %
4 9 .0 %
4 7 .0 %
5 0 .0 %
R 0 .0 %
0 .0 %
0 .0 %
0 .0 %
ISR 2 .0 %
2 .0 %
2 .0 %
2 .0 %
Length of lesion
< 10mm 1 4 .0 %
1 2 .0 % *
1 4 .0 %
1 2 .0 % *
11-20mm 6 0 .0 %
6 5 .0 % *
6 0 .0 %
6 5 .0 % *
>20mm 3 5 .0 %
3 0 .0 % *
3 6 .0 %
3 0 .0 % *
Stenosis before 100%
6 1 .7 %
Yes 6 1 .4 %
6 2 .4 %
6 1 .9 %
Timi flow before >3
2 2 .6 %
Yes 1 9 .8 % *
2 2 .3 %
1 9 .6 % *
Thrombus
7 6 .0 %
Yes 8 3 .0 % *
7 7 .0 %
8 3 .0 % *
Type of stent
5 .0 % 5 .0 %
DES 7 .0 % * 7 .0 % *
Others 92.1%
9 3 .9 %*
91.6%
9 3 .8 % *
Indication of stents
4 7 .2 %
direct stenting 4 3 .7 % *
4 6 .0 %
4 4 .0 % *
4 9 .8 %
others 5 4 .7 % *
5 0 .4 %
5 5 .0 % *
Other operations
1 6 .3 %
Inhibitors IIb/IIIa 2 2 .3 % *
1 7 .2 %
2 2 .8 % *
* Statistically significant
0 .6 %
difference between TFA IABP 0 .2 % *
2 .4 %
0 .8 % *
and TRA; tested by 7 .9 % 8 .0 %
Fisher’s exact test Thromboaspiration 1 8 .1 % * 1 8 .1 % *

17. TRA vs TFA: no difference in number of treated lesions
per procedure
TFA Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
without cardiogenic shock (N=20112) (N=21461)
TRA
N=15803
N=14858
18000 18000
16000 16000
Number of PCI
14000 14000
12000 12000
10000 10000
8000 8000
N=3012
6000 6000
N=2760
N=1724
N=1775
4000 4000
N=514
N=456
N=247
N=225
N=48
N=37
N=67
N=35
2000 N=5 2000
N=5
0 0
Number of treated lesions per PCI Number of treated lesions per PCI
Median Median
Mean ± SD Min - Max Mean ± SD Min - Max
(5th;95th
perc.) (5th;95th perc.)
Total 1.2 ± 0.5 1(1;2) 1-6 Total 1.2 ± 0.5 1(1;2) 1-6
Femoral 1.2 ± 0.5 1(1;2) 1–6 Femoral 1.2 ± 0.5 1(1;2) 1-6
Radial 1.2 ± 0.4 1(1;2) 1-5 Radial 1.2 ± 0.4 1(1;2) 1-5

18. Mortality at 30th day: TRA better than TFA even after
exclusion of cardiogenic shock
Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
TFA without cardiogenic shock (N=20112)
0% 10% 20% 30% 40%
(N=21461)
Anamnesis 0% 10% 20% 30% 40%
TRA
7 .2 % 1 2 .5 %
IM 6 .1 % 7 .6 % *
8 .3 % 1 2 .5 %
DM 5 .1 % * 6 .8 % *
1 0 .9 % 1 4 .9 %
CMP 4 .3 % * 6 .9 % *
5 .2 % 9 .1 %
CABG 1 1 .1 % 1 0 .0 %
4 .6 % 7 .8 %
previous PCI 3 .9 % 4 .4 %
Diseased vessels
9 .0 % 2 1 .8 %
Stem ACS 9 .3 % 1 7 .5 %
3 .5 % 4 .6 %
1VD 1 .3 % * 1 .5 % *
4 .8 % 6 .9 %
2VD 3 .2 % 4 .1 % *
7 .3 % 1 2 .9 %
3VD 5 .1 % 7 .7 % *
Ejection fraction
1 .8 % 2 .0 %
> 50% 1 .0 % 1 .0 %
5 .9 % 7 .4 %
30-50% 4 .2 % 5 .3 %
1 8 .4 % 3 3 .3 %
<30% 2 6 .7 % 2 7 .5 %
Character of operation
5 .0 % 7 .9 %
Emergent 2 .7 % * 3 .7 % *
2 .6 % 7 .4 %
Elective 0 .0 % 5 .0 %
4 .9 % 4 .9 %
Ad hoc 3 .0 % 0 .0 %
Segment
1 6 .7 % 3 9 .9 %
LMCA 1 1 .1 % 2 5 .0 %
6 .0 % 9 .3 %
RIA - RD 3 .9 % * 5 .1 % *
RC - RMS
4 .7 %
2 .4 % ALL ø 4.7% 5 .1 %
8 .4 %
* ALL ø 7.4%
* Statistically significant 4 .0 % TFA ø 5.0% 5 .9 % TFA ø 7.8%
difference between TFA ACD 1 .9 % * 3 .3 % *
and TRA; tested by 6 .3 % TRA ø 2.8% 9 .8 % TRA ø 3.9%
ML chi-squared test Bypass 0 .0 % 0 .0 %

19. Mortality at 30th day: increase of mortality in complex
lesions, absence of TIMI 3 flow before PCI, need of
IABP
Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
TFA without cardiogenic shock (N=20112)
0% 20% 40% 60%
(N=21461)
Type of lesion
TRA A 12 .7 %
.7 %
B1 23.7 %.4 %
*
B2 1 .5 %4 .7 %
* *
C 3 .7 % %
6 .0
* *
R 0 .0 % 8 .3 %
ISR 3 .2.2 %
5
%
Length of lesion
< 10mm 5 .1 %
1 .2 % * *
11-20mm 4 .3 %
2 .3 % * *
>20mm 6 .3 %
4 .3 % *
Stenosis before 100%
5 .8 %
Yes 3 .6 % * *
Timi flow before >3
4 .0 %
Yes 1 .5 % * *
Thrombus
5 .0 %
Yes 3 .2 % * *
Type of stent
3 .1 %
DES 0 .7 % *
others 2 .6 %
4.5%
* *
Indication of stents
3 .2 %
direct stenting 1 .8 % ALL ø 4.7% * *
5 .7 % ALL ø 7.4%
others 3 .6 % TFA ø 5.0% * *
TFA ø 7.8%
Others operation TRA ø 2.8% TRA ø 3.9%
6 .0 %
Inhibitors IIb/IIIa 4 .1 % *
3 6 .3 %
IABP 2 5 .0 %
6 .3 %
Thromboaspiration 2 .8 %
* *

20. Survival of patients after 30th day after admission
Patients with TFA or TRA and STEMI Patients with TFA or TRA and STEMI
without cardiogenic shock (N=19 810) (N=19 875)
Log-rank test Log-rank test
p=0.452 p=0.407
TFA TRA TFA TRA
Survival Survival
95% CI 95% CI 95% CI 95% CI
1 year 95.4 (95.1; 95.7) 96.1 (95.2; 97.0) 1 year 95.1 (94.7;95.1) 95.9 (95.0;96.8)
3 year 90.3 (89.8; 90.8) 91.0 (89.2; 92.8) 3 year 90.0 (89.5;90.5) 90.7 (88.9;92.5)
5 year 86.6 (85.9; 87.3) 83.4 (78.4; 88.4) 5 year 86.3 (85.6;87.0) 83.3 (78.4;88.2)

21. NRKI registry summary
• Data from the Czech National registry for cardiovascular interventions
(2005-2009) were analyzed with focus on differences between access
for PCI (TRA vs. TFA) and presence of cardiogenic shock
• Statistically significant differences between TRA and TFA were found
both for their basic characteristics and mortality of patients
• Differences between TRA and TFA in mortality at 30th day after
admission were found for patients with STEMI with/without cardiogenic
shock (TRA had lower mortality at 30th day after admission then TFA)
• For long-term survival differences between TRA and TFA were not found
both for patients with STEMI with/without cardiogenic shock
• Due to large sample size the statistical significance of results should be
interpreted in context of their clinical significance

22. Implications for TRA in STEMI
• TRA shoud be default access for all STEMI patients
– Lower mortality at 30 day, same mortality at 1 year
– Better early results of TRA can be partially explained by
→ lower risk profile
→ different pharmacological regimen
→ more experienced PCI operators
– TRA reduce vascular complications and access site bleeding…
– …small or no difference in large bleeding (non CABG,
gastrointestinal, genitourinary, intracranial)
• Pts in profound cardiogenic shock (pulseless) are excluded from
trials, but they contibute substantially to the mortality of all
STEMI
• Operators should be high volume and trained in both accesses

23. STEMI – RADIAL ST Elevation Myocardial
Infarction treated by RADIAL or femoral approach
700 patients with STEMI <12 hours reffering to the cathlab for pPCI (24/7)
• randomization 1:1 (electronically by www.fnplzen.cz/radial with password for
each investigator)
• intention to treat analysis
• primary endpoint - bleeding and access site complications at 30 days
• secondary endpoints - MACE
- primary access site failure - angiographical
procedure success - contrast media consumption -
procedural and flouroscopic times
- duration of hospital/ICU stay
- TVR/TLR - any new hospitalization
Study start date - October 2009
End of enrollment - December 2011
Principal investigator – Ivo Bernat, Pilsen
Country: Czech Republic
Centers: University Hospital Pilsen, University Hospital Hradec Kralove,
Nemocnice Na Homolce, Prague, Regional Hospital Liberec