A Randomized Trial of Radial vs Femoral Approaches for Primary PCI

1. A Randomized Trial of Radial vs.
Femoral Approaches for Primary PCI
Ivo Bernat, MD
Assistant-Professor of Medicine
University Hospital Pilsen, Czech Republic

2. Disclosure Statement of Financial Interest
I, Ivo Bernat 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. Background
• STEMI patients are frequently aggressively anticoagulated
with high rates of femoral access site bleeding after pPCI
• Radial approach significantly lowers access site bleeding
in comparison to femoral
• Radial approach evidence in STEMI patients (before RIVAL)
only from single centers randomized trials comparing FA
and RA in STEMI and one meta-analysis
• In STEMI population from RIVAL, there was a significant
reduction in access-site complications and mortality with
neutral effect on non-CABG major bleeding (OASIS criteria).

5. Meta-analysis radial versus femoral in STEMI
Vorobcsuk A. et al, Am Heart J 2009;158:814-21

6. Multicenter randomized trial RA vs FA in STEMI
Hypothesis:
• Radial approach will reduce the incidence of major bleeding
and entry site complications (primary endpoint) and will be
clinically not inferior to femoral approach in acute STEMI and
primary PCI (secondary endpoints)

7. HORIZONS-AMI: 30 Day Major Bleeding (non-CABG)
Heparin + GPIIb/IIIa inhibitor (n=1802)
Bivalirudin monotherapy (n=1800)
Major Bleeding (%)
Primary Endpoint
8.4%
5.0%
HR [95%CI] =
0.59 [0.45, 0.76]
P<0.0001
Time in Days
Stone G.et al, NEJM 2008;358:2218-30

8. HORIZONS-AMI bleeding definition
Major bleeding (non-CABG) :
• Intracranial bleeding
• Intraocular bleeding
• Retroperitoneal bleeding
• Access site bleed requiring intervention/surgery
• Hematoma ≥5 cm
• Hgb  ≥3g/dL with an overt source
• Hgb  ≥4g/dL w/o overt source
• Reoperation for bleeding
• Blood product transfusion
Stone G.et al, NEJM 2008;358:2218-30

9. Why radial ?

10. STEMI - RADIAL
- ST Elevation Myocardial Infarction treated by RADIAL or femoral approach
Multicenter Randomized Trial Comparing
Radial and Femoral Approaches in Primary PCI
Investigator-Initiated-trial conducted by
Academic Cardiologists in Czech Republic :
Study is supported by grant from the Ministry of Education
of the Czech Republic (Charles University in Prague Study start date - October 2009
Research Project No. MSM 0021620817), by grant form the
Ministry of Health of the Czech Republic (FN Hradec Kralove
Research Project No. MSM 00179906), and by Regional
Hospital Liberec Research projects foundation

11. STEMI – RADIAL
Inclusion criteria: Exclusion criteria :
• age over 18 years • Killip IV class or unconsciousness
• admission for STEMI <12 hours after • patient disagreement
onset of symptoms • prior aortobifemoral bypass
• ability to sign written informed • absence of either radial or femoral artery
consent pulsation
• participation in another clinical trial
randomizing ACS patients using
antithrombotic drug.
• negative Allen's test or Barbeau test type D
• treatment with oral anticoagulants

12. Study design:
700 STEMI patients in 4 PCI centers 24/7
electronic randomization
in cathlab after written 1:1 randomization femoral or radial approach
inform consent
immediate CAG + pPCI
radial approach femoral approach
Intention to treat
48 hours
+
30 days

14. Primary and secondary endpoints - at 30 days
• Primary - Major Bleeding (HORIZONS-AMI criteria)
- Access Site Complications (pseudo-aneurysm, A/V Fistula, Severe Hematoma,
Access-site complication requiring surgical or Percutaneous Intervention)
• Secondary: - MACE (Death, Re-MI, Stroke)
- Access site failure
- Procedural success
- Contrast media consumption
- Procedural and fluoroscopic times
- Duration of hospital/ICU stay
- TVR/TLR
- New hospitalization

15. Study centers

16. Sample size
• Superiority of radial approach compared to femoral in
terms of major bleeding and access site complication
• The trial has 80% power to detect 70% relative
reduction in major bleeding and access site
complications with radial approach compared to
femoral approach with an alpha level of 0.05
assuming a reference rate of 6.5%.

17. Electronic CRF for: randomization - acute procedure - 48 h - 30 d control
(www.fnplzen.cz/radial)

18. Patient recruitment
N = 590

19. Aknowledgements
• STEMI-RADIAL investigators - 4 centers:
Pesek J, Koza J, Smid M (Pilsen)
Dusek J, Brtko M, Polansky P, Bis J (Hradec Kralove)
Hrabos V, Sembera Z (Liberec)
Aschermann O, Kmonicek P (Prague)
• Steering committee :
Bernat I (PI), Horak D, Stasek J, Mates M, Rokyta R, Ostadal P,
Bertrand O.

20. Summary
STEMI-RADIAL Randomized Trial has the potential to show that
radial approach in comparison to femoral approach can
significantly reduce major bleeding and access site
complications in patients with STEMI treated by primary PCI.