P3700Intracoronary tenecteplase versus abciximab as adjunctive treatment during primary PCI in acute myocardial infarction of anterior location

Background: Primary PCI is the preferred reperfusion strategy in patients with STEMI, but controversy remains about the optimal adjunctive antithrombotic therapy and its route of administration. There are no randomised trials comparing intracoronary (IC) administration of fibrinolytic agents to that of GP IIb/IIIa inhibitors during primary PCI. Our purpose was to compare the effects of IC administration of tenecteplase to that of abciximab on myocardial perfusion and infarct size in patients with acute STEMI of anterior location undergoing primary PCI. Methods: We conducted a pilot study consisting in a phase-III, single-center, prospective, randomised clinical trial. Seventy-six patients with acute anterior STEMI were randomised to receive an IC infusion of reduced-dose tenecteplase (one fifth part of systemic dose) or abciximab (standard dose) during primary PCI. All patients were pretreated with heparin, aspirin and clopidogrel. Two days after primary PCI, coronary angiography was repeated to obtain parameters of epicardial flow (corrected TIMI frame count) and myocardial perfusion (TIMI myocardial perfusion grade- TMPG-, grades 0–3) for an ulterior blinded assessment at an external independent core-lab. Major adverse cardiac events included cardiac death, infarction, stroke and urgent target vessel revascularisation. A cardiac-MRI was performed at 4 months at an external institution blinded to the treatment groups in order to assess infarct size (the primary end-point of study) and LV function.