Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome the RIFLE...
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Transcript of Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome the RIFLE...
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, MDGiuseppe Sangiorgi, MD
F R
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.
• 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
• 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.
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).
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%
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
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
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
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 (%)NoneLMTLADCxRCAGraft
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 (%)0-12-3
3.7%96.3%
3.8%96.2%
3.6%96.4%
0.871
Procedural characteristics
RIFLE STEACS – population
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%
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%
Cardiac death MyocardialInfarction
Target LesionRevascularization
CerebrovascularAccident
femoral arm radial armp = 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%
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
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
• 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
Damn Damn Femoral!Femoral!
Hi hi hi,Hi hi hi,mine was mine was
randomized to radial randomized to radial
I guess, I guess, It’s just not It’s just not
my daymy day