OBJECTIVES: To compare a loading dose of 600 mg clopidogrel given in the prehospital phase versus clopidogrel administered only after the diagnostic angiogram in patients with STEMI scheduled for primary PCI. BACKGROUND: The optimal time and dose for the initiation of clopidogrel therapy in patients with STEMI scheduled for primary PCI has not been studied in prospective randomized trials. METHODS: The primary efficacy endpoint was the TIMI 2/3 patency of the infarct-related artery in the diagnostic angiography immediately prior to PCI. RESULTS: We randomized 337 patients to prehospital (n = 166) loading dose versus standard therapy (n = 171). The time interval between initiation of clopidogrel therapy and diagnostic angiography was 47 min. TIMI 2/3 patency before PCI was not different between the groups (49.3 vs. 45.1%, P = 0.5). We observed a trend towards a reduction of the combined endpoint death, re-infarction, and urgent target vessel revascularization in the prehospital-treated patients (3.0 vs. 7.0%, P = 0.09), this difference was significant if patients were classified as treated (4/161 vs. 13/174; 2.5 vs. 7.5%, P < 0.05). There was no difference in TIMI major bleeding complications (9.1 vs. 8.2%, P = 0.8). CONCLUSIONS: Early inhibition of the platelet ADP-receptor with a high loading dose of 600 mg clopidogrel given in the prehospital phase in patients with STEMI scheduled for primary PCI is safe, did not increase pre-PCI patency of the infarct vessel, but was associated with a trend towards a reduction in clinical events.
RCT Entities:
OBJECTIVES: To compare a loading dose of 600 mg clopidogrel given in the prehospital phase versus clopidogrel administered only after the diagnostic angiogram in patients with STEMI scheduled for primary PCI. BACKGROUND: The optimal time and dose for the initiation of clopidogrel therapy in patients with STEMI scheduled for primary PCI has not been studied in prospective randomized trials. METHODS: The primary efficacy endpoint was the TIMI 2/3 patency of the infarct-related artery in the diagnostic angiography immediately prior to PCI. RESULTS: We randomized 337 patients to prehospital (n = 166) loading dose versus standard therapy (n = 171). The time interval between initiation of clopidogrel therapy and diagnostic angiography was 47 min. TIMI 2/3 patency before PCI was not different between the groups (49.3 vs. 45.1%, P = 0.5). We observed a trend towards a reduction of the combined endpoint death, re-infarction, and urgent target vessel revascularization in the prehospital-treated patients (3.0 vs. 7.0%, P = 0.09), this difference was significant if patients were classified as treated (4/161 vs. 13/174; 2.5 vs. 7.5%, P < 0.05). There was no difference in TIMI major bleeding complications (9.1 vs. 8.2%, P = 0.8). CONCLUSIONS: Early inhibition of the platelet ADP-receptor with a high loading dose of 600 mg clopidogrel given in the prehospital phase in patients with STEMI scheduled for primary PCI is safe, did not increase pre-PCI patency of the infarct vessel, but was associated with a trend towards a reduction in clinical events.
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Authors: Philippe Gabriel Steg; Stefan James; Robert A Harrington; Diego Ardissino; Richard C Becker; Christopher P Cannon; Håkan Emanuelsson; Ariel Finkelstein; Steen Husted; Hugo Katus; Jan Kilhamn; Sylvia Olofsson; Robert F Storey; W Douglas Weaver; Lars Wallentin Journal: Circulation Date: 2010-11-08 Impact factor: 29.690
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