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CLINICAL RESEARCH: CLINICAL TRIAL

Randomized Early Versus Late Abciximab in Acute Myocardial Infarction Treated With Primary Coronary Intervention (RELAx-AMI Trial)

Division of Cardiology, Misericordia e Dolce Hospital, Prato, Italy.

Manuscript received July 27, 2006; revised manuscript received December 6, 2006, accepted December 10, 2006.

^_* Reprint requests and correspondence: Dr. Mauro Maioli, Via degli Arcipressi 3, 50143, Florence, Italy. (Email: mauromaioli{at}tiscali.it).

Objectives: This prospective randomized trial evaluates the impact of early abciximab administration on angiographic and left ventricular function parameters.

Background: Glycoprotein IIb/IIIa inhibitors improve myocardial reperfusion in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI), but optimal timing of administration remains unclear.

Methods: Two-hundred ten consecutive patients with first AMI undergoing primary PCI were randomized to abciximab administration either in the emergency room (early group: 105 patients) or in the catheterization laboratory, after coronary angiography (late group: 105 patients). Primary end points were initial Thrombolysis In Myocardial Infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), and myocardial blush grade (MBG), as well as left ventricular function recovery as assessed by serial echocardiographic evaluations.

Results: Angiographic pre-PCI analysis showed a significantly better initial TIMI flow grade 3 (24% vs. 10%; p = 0.01), cTFC (78 ± 30 frames vs. 92 ± 21 frames; p = 0.001), and MBG 2 or 3 (15% vs. 6%; p = 0.02) favoring the early group. Consistently, post-PCI tissue perfusion parameters were significantly improved in the early group, as assessed by 60-min ST-segment reduction 70% (50% vs. 35%; p = 0.03) and MBG 2 or 3 (79% vs. 58%; p = 0.001). Left ventricular function recovery at 1 month was significantly greater in the early group (mean gain ejection fraction 8 ± 7% vs. 6 ± 7%, p = 0.02; mean gain wall motion score index 0.4 ± 0.3 vs. 0.3 ± 0.3, p = 0.03).

Conclusions: In patients with AMI treated with primary PCI, early abciximab administration improves pre-PCI angiographic findings, post-PCI tissue perfusion, and 1-month left ventricular function recovery, possibly by starting early recanalization of the infarct-related artery.

Abbreviations and Acronyms   AMI = acute myocardial infarction   cTFC = corrected Thrombolysis In Myocardial Infarction frame count   EF = ejection fraction   IRA = infarct-related artery   LV = left ventricle/ventricular   MACE = major adverse cardiac events   MBG = myocardial blush grade   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction   TIMI = Thrombolysis In Myocardial Infarction   WMSI = wall motion score index

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