Bernat I - AIMRADIAL 2013 - STEMI-RADIAL trial

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A prospective randomized trial of radial vs. femoral access in patients with ST-segment elevation myocardial infarction; 1 year results

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  • Bernat I - AIMRADIAL 2013 - STEMI-RADIAL trial

    1. 1. STEMI-RADIAL - 1 year results A Prospective Randomized Trial of Radial vs. Femoral Access in Patients with ST-Segment Elevation Myocardial Infarction I Bernat, D Horak, J Stasek, M Mates, P Ostadal, J Pesek, V Hrabos, J Dusek, J Koza, Z Sembera, M Brtko, O Aschermann, M Smid, P Polansky, AA Mawiri, J Bis, J Vojacek, O Costerousse, OF Bertrand, R Rokyta University Hospital and Faculty of Medicine Pilsen, Regional Hospital Liberec, University Hospital Hradec Kralove, Na Homolce Hospital Prague, Université Laval Quebec. Czech Republic, Canada (ClinicalTrials.gov. NCT 00136187)
    2. 2. Disclosure: Ivo Bernat, MD I have no relevant financial interests to disclose
    3. 3. STEMI-RADIAL - objectives To compare radial vs femoral approach in primary PCI for patients with STEMI < 12 hours in very high volume radial centers (> 80% primary PCI)
    4. 4. Four study centers in the Czech Republic No industry funding -  University Hospital Pilsen Patient enrolment -  Regional Hospital Liberec -  University Hospital Hradec Kralove -  Na Homolce Hospital Prague
    5. 5. STEMI RADIAL - Study design: 707 STEMI patients between October 2009 and February 2012 in 4 PCI centers (24/7) written inform consent in the cathlab electronic randomization to femoral or radial approach (www.fnplzen.cz/radial) immediate CAG + pPCI radial approach (n=348) Intention to treat femoral approach (n=359) Clinical followup at 30 days (100%) 1 year follow-up
    6. 6. STEMI-RADIAL - study criteria Inclusion criteria: •  •  •  age over 18 years admission for STEMI <12 hours after onset of symptoms ability to sign written informed consent Exclusion criteria : •  •  •  •  •  •  •  Killip IV class or unconsciousness patient refusal prior aortobifemoral bypass no radial or femoral artery pulse participation in another clinical trial negative Allen's test or Barbeau test type D treatment with oral anticoagulants
    7. 7. STEMI-RADIAL end-points •  Primary - HORIZONS-AMI bleeding and access site complication * •  Secondary - MACE (death, MI, stroke) - NACE - crossover - angiographic success - contrast volume - procedural and fluoroscopic times - ICU stay MACE and NACE at 30 days, 6 months, 1 year * Hematoma !15cm
    8. 8. STEMI RADIAL - baseline characteristics I. overall (n=707) Radial (n=348) Femoral (n=359) p value 62±11 62±11 61±11 0.16 Male gender 77% 75% 79% 0.24 Weight (kg) 84±15 85±16 83±14 0.056 Hypertension 61% 65% 57% 0.037 Diabetes 21% 22% 19% 0.27 Smoking 51% 48% 55% 0.06 Stroke 4.4% 4.9% 3.9% 0.58 Dyslipidemia 38% 38% 38% 1.00 Age (years)
    9. 9. STEMI RADIAL - baseline characteristics II. overall (n=707) Radial (n=348) Femoral (n=359) p value Prior MI 10.6% 9.2% 12% 0.27 Prior PCI 7.2% 7.8% 6.7% 0.66 Prior CABG 0.85% 0.9% 0.8% 1.0 Anterior MI 41% 40% 42% 0.7 Inferior MI 47% 47% 47% 0.88 Lateral MI 13% 14% 13% 0.66 Symptoms to balloon (min) 213(155-296) 215(157-301) 210(150-293) 0.28
    10. 10. STEMI RADIAL - procedural characteristics overall (n=707) Radial (n=348) Femoral (n=359) p value Crossover 2.1% 3.7% 0.6% 0.003 GPI IIb/IIIa 45% 45% 45% 0.88 Thromboaspiration 28% 26% 30% 0.32 104±32 103±34 105±31 0.41 ASA 99% 99% 99% 0.68 Clopidogrel 99% 99% 98% 0.51 Procedural time (min) 49±19 49±20 49±18 1.0 Fluoroscopy time (min) 8.0±5.1 7.9±4.7 8.0±5.5 0.76 UFH dose (IU/kg)
    11. 11. STEMI RADIAL - procedural characteristics overall (n=707) Radial (n=348) Femoral (n=359) p value 91% 91% 91% 0.79 Contrast volume (ml) 176±66 170±71 182±60 0.01 ICU stay (day) 2.8±2.4 2.5±1.7 3.0±2.9 0.0016 Angiographic success Final TIMI 0.62 0 1.3% 1.7% 0.8% 1 1.0% 1.1% 0.8% 2 5.5% 4.9% 6.1% 3 92% 92% 92%
    12. 12. STEMI RADIAL - results 30-day bleeding and access site compl. p=0.0001 80%
    13. 13. STEMI RADIAL - results 30-day MACE p = 0.7 4.2% 3.5% p = 0.64 3.1% 2.3% p = 0.72 0.8% p = 1.0 1.2% 0.3% 0.3% MACE = composite of death, myocardial infarction and stroke
    14. 14. STEMI RADIAL - results 30-day NACE p = 0.0028 11.0% p = 0.0001 58% 7.2% 4.6% p = 0.7 80% 4.2% 1.4% Net Adverse Clinical Event (NACE) = MACE + major bleeding MACE = composite of death, myocardial infarction and stroke 3.5%
    15. 15. 30-days results - LBCT TCT 2012 - JACC 2013 in press
    16. 16. STEMI RADIAL - 1- year follow up 707 STEMI patients Radial (n=348) Femoral (n=359) 30-days follow-up (100%) 1 year follow-up : death - 100% (National Health Information System Center) other data - 94% n=664 (lost to FU 6%) Radial n=326 Femoral n=338
    17. 17. Cardiac F vs R 30d noncardiac death F R 2-12m F R 1y Death total 3.1% 2.3% 1.7% 0.9% 4.8% 3.2% Cardiac 2.3% 2.3% 1.1% 0.3% 3.4% 2.6% Noncardiac 0.8% 0% 0.6% 0.6% 1.4% 0.6%
    18. 18. STEMI RADIAL - results >1 - 12 months MACE femoral arm radial arm p = NS 3.3% p = NS 2.8% 1.8% p = NS 1.5% 0.9% p = NS 1.2% 0.6% 0% MACE Death MI MACE = composite of death, myocardial infarction and stroke Stroke
    19. 19. STEMI RADIAL - results 30-day MACE p = 0.7 4.2% 3.5% p = 0.64 3.1% 2.3% p = 0.72 0.8% p = 1.0 1.2% 0.3% 0.3% MACE = composite of death, myocardial infarction and stroke
    20. 20. STEMI RADIAL - results 1-year MACE femoral arm radial arm p = 0.65 7.4% 6.4% p = 0.34 4.7% p = 1.00 3.2% p = 0.37 2.4 % 2.4% 0.3% MACE Death MI MACE = composite of death, myocardial infarction and stroke 0.9% Stroke
    21. 21. STEMI RADIAL - results >1-12 months NACE femoral p = NS 3.6% radial p = NS 3.1% p = NS 0.3% NACE 3.3% 2.8% 0.3% Bleeding Net Adverse Clinical Event (NACE) = MACE + major bleeding MACE = composite of death, myocardial infarction and stroke MACE
    22. 22. STEMI RADIAL - results 30-day NACE p = 0.0028 11.0% p = 0.0001 58% 7.2% p = 0.7 4.6% 4.2% 1.4% Net Adverse Clinical Event (NACE) = MACE + major bleeding MACE = composite of death, myocardial infarction and stroke 3.5%
    23. 23. STEMI RADIAL - results 1-year NACE femoral radial p = 0.0089 46% 14.1% p = 0.0001 7.7% p = 0.65 7.4% 7.5% 6.4% 1.7% NACE Bleeding Net Adverse Clinical Event (NACE) = MACE + major bleeding MACE = composite of death, myocardial infarction and stroke MACE
    24. 24. 1-year survival curve Radial Survival Femoral Log-rank P = 0.29 Days
    25. 25. Conclusion •  In patients with STEMI <12 hrs, radial approach was associated with a significant lower incidence of major bleeding and access site complications and significant better net clinical benefit at 30 days. •  Radial approach also reduced significantly ICU stay and contrast volume compared to femoral approach. •  Moreover radial approach was also associated with significant better net clinical benefit at 1 year. •  Our results support the use of radial approach in primary PCI in experienced radial centers as a first choice.

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