A Randomized Trial of Radial vs.Femoral Approaches for Primary PCI Ivo Bernat, MD Assistant-Professor of Medicine University Hospital Pilsen, Czech Republic
Disclosure Statement of Financial InterestI, Ivo Bernat DO NOT have a financial interest/arrangement oraffiliation with one or more organizations that could beperceived as a real or apparent conflict of interest in thecontext of the subject of this presentation.
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).
Meta-analysis radial versus femoral in STEMI Vorobcsuk A. et al, Am Heart J 2009;158:814-21
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)
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
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
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
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 Allens test or Barbeau test type D • treatment with oral anticoagulants
Study design: 700 STEMI patients in 4 PCI centers 24/7 electronic randomizationin cathlab after written 1:1 randomization femoral or radial approachinform consentimmediate CAG + pPCI radial approach femoral approach Intention to treat 48 hours + 30 days
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
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%.
Electronic CRF for: randomization - acute procedure - 48 h - 30 d control(www.fnplzen.cz/radial)
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.
SummarySTEMI-RADIAL Randomized Trial has the potential to show thatradial approach in comparison to femoral approach cansignificantly reduce major bleeding and access sitecomplications in patients with STEMI treated by primary PCI.