Your SlideShare is downloading. ×
  • Like
  • Save
Bernat I - AIMRADIAL 2013 - STEMI-RADIAL trial
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Now you can save presentations on your phone or tablet

Available for both IPhone and Android

Text the download link to your phone

Standard text messaging rates apply
Published

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

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

Published in Health & Medicine , Education
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
1,548
On SlideShare
0
From Embeds
0
Number of Embeds
4

Actions

Shares
Downloads
0
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide
  • This is the Bulleted List slide.
    To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
    The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
    If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
    Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
    Choose View / Master / Slide Master from your menu.
    Select the text at the bottom of the slide and type in a short version of your presentation title.
    Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)
  • This is the Bulleted List slide.
    To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
    The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
    If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
    Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
    Choose View / Master / Slide Master from your menu.
    Select the text at the bottom of the slide and type in a short version of your presentation title.
    Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)

Transcript

  • 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. Disclosure: Ivo Bernat, MD I have no relevant financial interests to disclose
  • 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. 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. 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. 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. 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)
  • 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. 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. 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. STEMI RADIAL - results 30-day bleeding and access site compl. p=0.0001 80%
  • 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. 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. 30-days results - LBCT TCT 2012 - JACC 2013 in press
  • 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. 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. 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. 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. 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. 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. 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. 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. 1-year survival curve Radial Survival Femoral Log-rank P = 0.29 Days
  • 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.