Bernat I - AIMRADIAL 2013 - STEMI-RADIAL trial

Bernat I - AIMRADIAL 2013 - STEMI-RADIAL trial

• 1.
  STEMI-RADIAL - 1year 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.
  Disclosure: Ivo Bernat, MD Ihave no relevant financial interests to disclose
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  STEMI-RADIAL - objectives Tocompare radial vs femoral approach in primary PCI for patients with STEMI < 12 hours in very high volume radial centers (> 80% primary PCI)
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  Four study centersin the Czech Republic No industry funding -  University Hospital Pilsen Patient enrolment -  Regional Hospital Liberec -  University Hospital Hradec Kralove -  Na Homolce Hospital Prague
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  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
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  STEMI-RADIAL - studycriteria 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.
  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.
  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)
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  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
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  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)
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  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%
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  STEMI RADIAL -results 30-day bleeding and access site compl. p=0.0001 80%
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  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
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  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%
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  30-days results - LBCTTCT 2012 - JACC 2013 in press
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  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
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  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%
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  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
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  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
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  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
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  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
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  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%
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  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
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  1-year survival curve Radial Survival Femoral Log-rankP = 0.29 Days
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  Conclusion •  In patientswith 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.