Radial vs Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome: the RIFLE STEACS Study

1. Radial versus Femoral
Randomized Investigation in ST
Elevation Acute Coronary Syndrome
the RIFLE STEACS study
Enrico Romagnoli, MD PhD
Principal investigators:
Enrico Romagnoli, MD PhD
Giuseppe Biondi-Zoccai, MD
Giuseppe Sangiorgi, MD

2. Disclosure Statement of Financial Interest
I, Enrico Romagnoli DO NOT have a financial
interest/arrangement or affiliation with one
or more organizations that could be
perceived as a real or apparent conflict of
interest in the context of the subject of this
presentation.

3. • Bleeding complications in patients with
acute coronary syndromes are a significant
predictor of mortality.
• We aimed to test whether transradial
access for ST elevation myocardial
infarction (STEMI) treatment is associated
with better outcome when compared to
transfemoral approach.
RIFLE STEACS - rationale

4. • The sample size was computed exploiting
the 30-day rate of NACE in STEMI patients
in the heparin-treated arm of the
HORIZONS-AMI study (12.1%), and
retrieving absolute risk reductions from a
systematic transradial approach averaging
4.5% stemming from meta-analyses*.
RIFLE STEACS – sample size
*Agostoni P. et al, J Am Coll Cardiol 2004;44:349-56.
Jolly SS, et al. Am Heart J. 2009;157:132-40.

5. RIFLE STEACS – end-points
 Net adverse clinical events (NACE) at 30
days, defined as the composite of cardiac
death, myocardial infarction (MI), target
lesion revascularization, stroke, or non-
coronary artery bypass graft (non-
CABG)-related bleeding.
 Non CABG-related bleeding at 30 days
(corresponding to type 2, type 3 and type
5 of BARC classification).

6. RIFLE STEACS - flow chart
Design
• DESIGN:
Prospective, randomized (1:1),
parallel group, multi-center trial.
• INCLUSION CRITERIA:
all ST Elevation Myocardial
infarction (STEMI) eligible for
primary percutaneous coronary
intervention.
• ESCLUSION CRITERIA:
contraindication to any of both
percutaneous arterial access.
international normalized ratio
(INR) > 2.0.
1001 patients enrolled between January
2009 and July 2011 in 4 clinical sites in Italy
Clinical follow-up at
1 month in 100%
Femoral arm
(N=501)
Radial arm
(N=500)
Femoral arm
(N=534)
Radial arm
(N=467)
Clinical follow-up at
1 month in 100%
Intention-to-treat analysis
4.7%
1.4%

7. overall
(1001)
Femoral arm
(n=501)
Radial arm
(n=500)
p
value
Age (years) 65±13 66±13 65±13 0.344
Female gender 26.7% 28.1% 25.2% 0.317
Body mass index 28±10 27±5 29±14 0.074
CKD (GRF <60 ml/min/1.732
) 23.8% 25.3% 22.2% 0.156
Diabetes 23.7% 24.4% 23.0% 0.656
LVEF 45±9% 45±10% 46±9% 0.228
Prior MI 14.1% 14.2% 14.0% 1.000
Prior stroke 4.1% 4.4% 3.8% 0.750
Prior revascularization 11.7% 10.4% 13.0% 0.202
Demographic characteristics
RIFLE STEACS – population

8. overall
(1001)
Femoral arm
(n=501)
Radial arm
(n=500)
p
value
Severity of CAD
Not significant
Single vessel disease
Double vessel disease
Triple vessel disease
1.1%
54.5%
28.5%
15.9%
1.2%
53.1%
29.7%
16.0%
1.0%
56.0%
27.2%
15.8%
0.789
Killip class
I
II
III
IV
67.7%
21.0%
5.2%
6.1%
65.9%
21.5%
5.6%
7.0%
69.6%
20.4%
4.8%
5.2%
0.515
Procedural characteristics
RIFLE STEACS – population

9. overall
(1001)
Femoral arm
(n=501)
Radial arm
(n=500)
p
value
Symptom-balloon time (min) 313±277 322±292 328±301 0.752
SBP at admission (mmHg) 128±28 126±28 129±27 0.138
Prior failed thrombolysis 7.6% 7.0% 8.2% 0.477
Heparin dose (U/Kg) 75.6±21 75.2±20 76.0±22 0.548
GP IIb/IIIa inhibitors 68.6% 69.9% 67.4% 0.414
Bivalirudin 7.6% 7.2% 8.0% 0.635
Thrombectomy 40.7% 40.5% 40.8% 0.949
Intra aortic balloon pump 8.0% 8.4% 7.6% 0.727
Procedural characteristics
RIFLE STEACS – population

10. overall
(1001)
Femoral arm
(n=501)
Radial arm
(n=500)
p
value
Occlusive lesion (%) 59.6% 59.7% 59.6% 1.000
Direct stenting (%) 28.1% 27.9% 28.2% 0.944
Target Vessel (%)
None
LMT
LAD
Cx
RCA
Graft
1.1%
0.6%
46.8%
16.3%
34.2%
1%
1.2%
0.8%
46.7%
15.0%
35.3%
1.0%
1.0%
0.4%
47.0%
17.6%
33.0%
1.0%
0.818
Final TIMI flow (%)
0-1
2-3
3.7%
96.3%
3.8%
96.2%
3.6%
96.4%
0.871
Procedural characteristics
RIFLE STEACS – population

11. NACE MACCE Bleedings
femoral arm radial armp = 0.003
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%

12. NACE MACCE Bleedings
femoral arm radial armp = 0.003
• Net Adverse Clinical Event (NACE) = MACCE + bleeding
• Major Adverse Cardiac and Cerebrovascular event (MACCE) = composite of
cardiac death, myocardial infarction, target lesion revascularization, stroke
30-day NACE rate
RIFLE STEACS – results
p = 0.029 p = 0.026
21.0%
11.4%
7.2%
12.2%
7.8%
13.6%

13. Cardiac death Myocardial
Infarction
Target Lesion
Revascularization
Cerebrovascular
Accident
femoral arm radial arm
p = 0.020
30-day MACCE rate
RIFLE STEACS – results
p = 1.000 p = 0.604 p = 0.725
9.2%
5.2%
1.4% 1.2% 1.8% 1.2% 0.6% 0.8%

14. 30-day bleeding rate
RIFLE STEACS – results
p = 1.000
12.2%
6.8%
2.6%
5.4% 5.2%
p = 0.026
Bleedings Access site related Non access site related
femoral arm radial arm
7.8%
47%
p = 0.002

15. OR CI 95% p value
Female gender 1.5 (1.1-2.3) 0.037
CKD 2.1 (1.4-3.1) 0.001
Radial access 0.6 (0.4-0.9) 0.012
Killip class 1.8 (1.5-2.2) 0.001
LAD culprit 1.7 (1.2-2.6) 0.006
TIMI 0 basal 1.4 (1.0-2.1) 0.073
LVEF <50% 1.6 (1.1-2.5) 0.025
TIMI 0-1 final 2.4 (1.1-5.1) 0.024
30-day NACE predictors
RIFLE STEACS – results
p= 0.002

16. • Radial access in patients with STEMI is
associated with significant clinical benefit, in
terms of both bleeding and cardiac mortality.
• Radial approach should thus no more be
considered a valid alternative to femoral one,
but become the recommended access site
for STEMI (international guideline).
RIFLE STEACS - conclusions

17. RIFLE STEACS – centres
Policlinico Casilino
Rome
Ospedale S. Pertini
Rome
Policlinico di Modena
Modena
Università di Torino
Turin