Philippe Gabríel Steg1, Stefan James1, Diego Ardissino1, Richard C. Becker1, Christopher P. Cannon1, Håkan Emanuelsson1, Ariel Finkelstein1, Steen Husted1, Hugo Katus1, Jan Kilhamn1, Sylvia Olofsson1, Robert F. Storey1, W. Douglas Weaver1, Lars Wallentin1
1From INSERM U-698, Paris, France (P.G.S.); Hôpital Bichat-Claude Bernard, AP-HP, Paris, France (P.G.S.); Université Paris 7, Paris, France (P.G.S.); Uppsala Clinical Research Center and Department Medical Sciences, Uppsala University, Uppsala, Sweden (S.J., S.O., L.W.); Duke Clinical Research Institute, Durham, NC (R.A.H., R.C.B.); Azienda Ospedaliero Universitaria di Parma, Parma, Italy (D.A.); TIMI Study Group, Brigham and Women's Hospital, Boston, Mass (C.P.C.); AstraZeneca Research and...
Tóm tắt
Background—
Aspirin and clopidogrel are recommended for patients with acute coronary syndromes (ACS) or undergoing coronary stenting. Ticagrelor, a reversible oral P2Y12-receptor antagonist, provides faster, greater, and more consistent platelet inhibition than clopidogrel and may be useful for patients with acute ST-segment elevation (STE) ACS and planned primary percutaneous coronary intervention.
Methods and Result—
Platelet Inhibition and Patient Outcomes (PLATO), a randomized, double-blind trial, compared ticagrelor with clopidogrel for the prevention of vascular events in 18 624 ACS patients. This report concerns the 7544 ACS patients with STE or left bundle-branch block allocated to either ticagrelor 180-mg loading dose followed by 90 mg twice daily or clopidogrel 300-mg loading dose (with provision for 300 mg clopidogrel at percutaneous coronary intervention) followed by 75 mg daily for 6 to 12 months. The reduction of the primary end point (myocardial infarction, stroke, or cardiovascular death) with ticagrelor versus clopidogrel (10.8% versus 9.4%; hazard ratio [HR], 0.87; 95% confidence interval, 0.75 to 1.01;
P
=0.07) was consistent with the overall PLATO results. There was no interaction between presentation with STE/left bundle-branch block and randomized treatment (interaction
P
=0.29). Ticagrelor reduced several secondary end points, including myocardial infarction alone (HR, 0.80;
P
=0.03), total mortality (HR, 0.82;
P
=0.05), and definite stent thrombosis (HR, 0.66;
P
=0.03). The risk of stroke, low in both groups, was higher with ticagrelor (1.7% versus 1.0%; HR,1.63; 95% confidence interval, 1.07 to 2.48;
P
=0.02). Ticagrelor did not affect major bleeding (HR, 0.98;
P
=0.76).
Conclusion—
In patients with STE-ACS and planned primary percutaneous coronary intervention, the effects of ticagrelor were consistent with those observed in the overall PLATO trial.
Clinical Trial Registration—
URL:
http://www.ClinicalTrials.gov
. Unique identifier: NCT00391872.