Hazard ratios (HRs) and 95% confidence intervals (CIs) were generated with the use of a Cox proportional-hazards model, and all reported P-values are two-sided. Data on patients randomized to ticagrelor 90 mg who would have qualified for the EU label ( n = 5374) are also presented in the Supplementary material online for the sake of completeness.Ĭumulative event rates at 3 years were calculated by the complement of the Kaplan–Meier (KM) survival estimates. Patients randomized to ticagrelor 60 mg or placebo who did not qualify per the EU label are termed the non-EU label group. The present analysis focuses on data from 10 779 patients that were randomized ≤2 years from qualifying MI or ≤1year from prior stopping ADP receptor inhibitor treatment, 5388 in the ticagrelor 60 mg and 5391 in the placebo group (EU label group). Patients were ineligible if there was planned use of a P2Y 12 receptor antagonist or anticoagulant therapy during the study period if they had a bleeding disorder, a history of intracranial bleeding, a central nervous system tumour, or an intracranial vascular abnormality or if they had had gastrointestinal bleeding within the previous 6 months or major surgery within the previous month.
5 In brief, patients aged at least 50 years were included with a spontaneous MI occurring 1–3 years prior to enrolment and at least one of the following additional high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or chronic renal dysfunction, defined as a creatinine clearance <60 mL/min as estimated by the Cockroft–Gault equation.
#PEGASUS BRILINTA TRIAL#
The design 8 and primary results of the trial have been published. Written informed consent was obtained from all the patients. The protocol was approved by the relevant ethics committee at each participating site. PEGASUS-TIMI 54 randomized patients with prior MI to ticagrelor 60 mg b.i.d., ticagrelor 90 mg b.i.d., or placebo, all on a background of low-dose aspirin. We, therefore, report the efficacy and safety in the PEGASUS-TIMI 54 subpopulation recommended for treatment in the EU label. in a clinically relevant subset of patients, treated according to the approved label. While the PEGASUS-TIMI 54 trial had wider inclusion criteria, the present analysis aimed to describe the effects of extended treatment with ticagrelor 60 mg b.i.d. can also be initiated up to 2 years from the MI, or within 1 year after stopping previous ADP receptor inhibitor treatment.
may be started without interruption as continuation therapy. (or other ADP receptor inhibitor) in high-risk MI patients, treatment with ticagrelor 60 mg b.i.d. 6 Accordingly, the CHMP-EMA approved European (EU) label recommends that, after the initial 1-year treatment with ticagrelor 90 mg b.i.d. 5 The benefit of ticagrelor appeared more marked in patients continuing on or restarting after only a brief interruption of adenosine diphosphate (ADP) receptor inhibition and in those closer to their qualifying MI. or 60 mg b.i.d., significantly reduced the risk of the composite of major adverse cardiovascular events by 15–16% in stable patients at high risk with a prior MI 1–3 years earlier. 3, 4 In PEGASUS-TIMI 54, ticagrelor, at doses of either 90 mg b.i.d.
1, 2 Notably, many stable patients with a history of myocardial infarction (MI) remain at high risk after this period. In acute coronary syndrome with or without ST-segment elevation, European guidelines recommend dual antiplatelet treatment for at least the first year.
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