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Enrico Romagnoli , MD PhD

Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndrome the RIFLE STEACS study. Enrico Romagnoli , MD PhD. F. R. Principal investigators: Enrico Romagnoli , MD PhD Giuseppe Biondi-Zoccai , MD Giuseppe Sangiorgi , MD. ClinicalTrials.gov NCT01420614.

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Enrico Romagnoli , MD PhD

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  1. Radial versus Femoral Randomized Investigation in ST Elevation Acute Coronary Syndromethe RIFLE STEACS study EnricoRomagnoli, MD PhD F R Principal investigators: EnricoRomagnoli, MD PhD Giuseppe Biondi-Zoccai, MD Giuseppe Sangiorgi, MD ClinicalTrials.gov NCT01420614

  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 1001 patients enrolled between January 2009 and July 2011 in 4 clinical sites in Italy 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. Femoral arm (N=501) Radial arm (N=500) 1.4% 4.7% Femoral arm (N=534) Radial arm (N=467) Clinical follow-up at 1 month in 100% Clinical follow-up at 1 month in 100% Intention-to-treat analysis ClinicalTrials.gov NCT01420614

  7. RIFLE STEACS – population Demographic characteristics

  8. RIFLE STEACS – population Procedural characteristics

  9. RIFLE STEACS – population Procedural characteristics

  10. RIFLE STEACS – population Procedural characteristics

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

  12. RIFLE STEACS – results 30-day MACCE rate p = 0.020 9.2% p = 1.000 p = 0.604 p = 0.725 5.2% 1.8% 1.4% 1.2% 1.2% 0.8% 0.6%

  13. RIFLE STEACS – results 30-day bleeding rate p = 0.026 p = 0.002 p = 1.000 12.2% 7.8% 6.8% 5.4% 5.2% 2.6%

  14. RIFLE STEACS – results 30-day NACE predictors p= 0.002

  15. 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

  16. RIFLE STEACS – centres PoliclinicoCasilino Rome Policlinico di Modena Modena Ospedale S. Pertini Rome Università di Torino Turin

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