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R andomized E arly versus L ate A bci X imab in A cute M yocardial I nfarction treated with primary coronary inter

R andomized E arly versus L ate A bci X imab in A cute M yocardial I nfarction treated with primary coronary intervention (RELAx-AMI Trial). Mauro Maioli M.D., Francesco Bellandi M.D., Mario Leoncini M.D., Anna Toso M.D. and Roberto Piero Dabizzi M.D..

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R andomized E arly versus L ate A bci X imab in A cute M yocardial I nfarction treated with primary coronary inter

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  1. Randomized Early versus Late AbciXimab in Acute Myocardial Infarction treated with primary coronary intervention (RELAx-AMI Trial) Mauro Maioli M.D., Francesco Bellandi M.D., Mario Leoncini M.D., Anna Toso M.D. and Roberto Piero Dabizzi M.D.. Division of Cardiology, Prato – Italy. Journal of American College Cardiology 2007; 48:1517-24.

  2. Background • Investigations on glycoprotein IIb/IIIa inhibition in acute ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) have shown the efficacy of abciximab in improving clinical and angiographic outcome. • Adjunctive abciximab therapy, administered in catheterization laboratory prior to primary PCI, is associated with a significant reduction in 30-day reinfarction and in short- and long-term mortality in patients with STEMI treated with primary angioplasty. • The Admiral trial suggested that early abciximab administration was associated with marked amplification of treatment effect. However, the real benefit of early treatment has not yet been established. M. Maioli et al, JACC 2007;48:1517-24.

  3. Objectives of the trial • In this prospective randomized trial on patients with AMI treated with primary stenting, we evaluated the impact on angiographic outcome, microvascular reperfusion, myocardial salvage and left ventricular function of abciximab administered in the emergency room compared to abciximab administered in the catheterization laboratory. End Points of the trial • The primary endpoint of the trial was the pre-interventional angiographic finding evaluated in terms of TIMI grade flow. In addition, we analyzed cTFC and MBG. Secondary endpoints were infarct size (measured by cumulative release of serum cardiac markers) and left ventricular functional recovery at one month (echocardiographic ejection fraction and wall motion score index). M. Maioli et al, JACC 2007;48:1517-24.

  4. Flow patients through RELAx-AMI trial Patients referred for AMI n = 232 22 pts excluded Randomized n = 210 Assigned to Early Abciximab n = 105 Assigned to Late Abciximab n = 105 3 pts died 6 pts died One month echocardiographic analysis n = 102 One month echocardiographic analysis n = 99 M. Maioli et al, JACC 2007;48:1517-24.

  5. Methods • Exclusion criteria: - previous AMI (7 pts) - previous PCI or CABG (6 pts) - LBBB (3 pts) - oral anticoagulation (2 pts) - contraindication to aspirin (2 pts) - recent stroke or surgery (2 pts) • Study drugs:- Abciximab (0.25 mg/kg as a bolus followed by a 12-h infusion of 0.125 mcg/kg/min) either in the emergency room (Early group) or in the catheterization laboratory (Late group) - Heparin as a bolus of 70 U/kg (maximum, 7000 U) together with 250 mg of aspirin intravenously, in the emergency room.- Clopidogrel 300 mg,immediately after the procedure M. Maioli et al, JACC 2007;48:1517-24.

  6. RELAx-AMI: Baseline clinical characteristics of the patients - 1 M. Maioli et al, JACC 2007;48:1517-24.

  7. RELAx-AMI: Baseline clinical characteristics of the patients - 2 Procedural times are presented as median with interquartile ranges M. Maioli et al, JACC 2007;48:1517-24.

  8. RELAx-AMI: Angiographic results - 1 M. Maioli et al, JACC 2007;48:1517-24.

  9. RELAx–AMI: TIMI flow and MBG at basal angiography Basal TIMI Flow Basal Myocardial Blush Grade p=.001 p=.028 M. Maioli et al, JACC 2007;48:1517-24.

  10. RELAx-AMI: Angiographic results - 2 M. Maioli et al, JACC 2007;48:1517-24.

  11. RELAx–AMI: Myocardial Blush Grade at final angiography p=.001 M. Maioli et al, JACC 2007;48:1517-24.

  12. RELAx-AMI: Procedural results M. Maioli et al, JACC 2007;48:1517-24.

  13. RELAx-AMI: Electrocardiographic and Laboratory results M. Maioli et al, JACC 2007;48:1517-24.

  14. RELAx-AMI: Electrocardiographic results 60 minutes post PCI ST-T Resolution p=.004 p=.026 M. Maioli et al, JACC 2007;48:1517-24.

  15. RELAx-AMI: One month left ventricle function recovery M. Maioli et al, JACC 2007;48:1517-24.

  16. RELAx-AMI: Left Ventricular Function by Timing of Abciximab administration Global Regional p=.014 NS NS p=.014 p =.031 p=.023 Early Abiciximab Late Abciximab M. Maioli et al, JACC 2007;48:1517-24.

  17. RELAx-AMI: Scintigraphic evaluation F. Bellandi et al, Int J Cardiol 2006;108:36-42

  18. RELAx-AMI: Scintigraphic evaluation NS p= .007 p= .028 Early Abiciximab Late Abciximab F. Bellandi et al, Int J Cardiol 2006;108:36-42

  19. RELAx-AMI: one month clinical follow-up and bleeding complications M. Maioli et al, JACC 2007;48:1517-24.

  20. Conclusion • The results of the present trial suggest that, in patients with first AMI treated with PCI, early abciximab administration (i.e. in the emergency room) compared to treatment started in the catheterization laboratory significantly improves pre-procedural angiographic epicardial flow (evaluated by TIMI grade flow) and tissue perfusion (MBG 2 or 3). • Moreover, post-interventional parameters of myocardial reperfusion (i.e., MBG  2 and ST-segment resolution) were also improved and this is associated with a smaller infarct size and with an improved left ventricular function at one month follow-up. M. Maioli et al, JACC 2007;48:1517-24.

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