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

RIFLE STEACS – centres

Policlinico CasilinoRome

Ospedale S. PertiniRome

Policlinico di ModenaModena

Università di TorinoTurin