PARIS--29 Aug--PRNewswire-AsiaNet/ InfoQuest
This Release is Not Intended for US Media
Additional Analyses from PLATO, Presented at ESC Congress, Examined Impact of BRILINTA vs. Clopidogrel on Stent Thrombosis in PCI Patients and Long-Term Cystatin C Levels
AstraZeneca today announced results from a blinded review of clinical data from patients in the PLATO trial who had died following coronary artery bypass graft (CABG) surgery. The blinded review found that, when compared to clopidogrel, BRILINTA (ticagrelor) was more commonly associated with fewer cardiac, bleeding or infectious complications that directly caused or contributed to death following CABG. These data were presented today at the European Society of Cardiology (ESC) congress in Paris, France.
"These data may help to further understand the factors that contribute to the ability of ticagrelor to provide superior outcomes over clopidogrel in acute coronary syndrome patients, including when a surgical intervention like CABG is required," said Christoph Varenhorst, MD, Researcher at the Uppsala Clinical Research Centre.
The blinded review (Abstract #83082) categorised differences in causes of post-CABG deaths between treatment arms, and found that total rates of vascular deaths and non-vascular deaths from the time of CABG until study end for the ticagrelor and clopidogrel groups were 4.0% (25/632) vs. 7.5% (47/629) and 0.6% (4/632) vs. 1.7% (11/629), respectively. Results showed there were numerically fewer cardiovascular-related deaths from heart attack, heart failure, arrhythmia/sudden death, haemorrhagic stroke/intracranial haemorrhage and bleeding/other haemorrhage among patients treated with ticagrelor compared to clopidogrel (1.6% vs. 2.2%; 0.9 vs. 1.4%; 0.5% vs. 1.4%; 0.0% vs. 0.5%; 0.3% vs. 0.6%). Among factors directly causing or contributing to death, bleeding (27 vs. 9, p=0.002) and infection (16 vs. 6, p=0.033) occurred more commonly in the clopidogrel group, compared to the ticagrelor group.
This blinded review is a follow-up to an analysis presented at the American College of Cardiology (ACC) Annual Scientific Sessions in March 2010. That analysis, which included the 1,261 acute coronary syndrome (ACS) patients in PLATO who underwent CABG within 7 days after discontinuing either clopidogrel or ticagrelor (ticagrelor n=632 and clopidogrel n=629), showed a reduction in total mortality of 51% with ticagrelor. Since the 2010 analysis only recognised causes of death as vascular or non-vascular only, there was a need to further investigate the causes of post-CABG deaths between the treatment arms, the results of which were presented today.
AstraZeneca also presented today at the ESC meeting two additional analyses from the PLATO trial.
One analysis (Abstract #86176) examined the impact of ticagrelor versus clopidogrel on stent thrombosis in ACS patients hospitalised with or without ST-elevation ACS. The data from this analysis showed that ticagrelor reduced definite stent thrombosis compared with clopidogrel, independent of type of ACS, diabetes status, stent type, loading dose of aspirin and dose of clopidogrel pre-randomisation (1.37% vs. 1.93%, HR 0.67, p=0.0091).
The greatest reductions for ticagrelor were demonstrated for both late (>30 days, HR 0.48) and sub-acute stent thrombosis (24 h-30 days, HR 0.60). Prior stroke, peripheral artery disease, ST-elevation ACS and higher heart rate were predictors of definite stent thrombosis.
The other analysis (Abstract #86010) investigated cystatin C, a blood biomarker and indicator of kidney function, as an independent risk predictor for death or heart attack in patients with ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) ACS.
NOTES TO EDITORS
ABOUT PLATO
PLATO was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of ticagrelor versus clopidogrel, both given in combination with aspirin and other standard therapy, designed to establish whether ticagrelor could achieve a clinically meaningful reduction in CV end points in ACS patients, above and beyond those afforded by clopidogrel.
The study demonstrated that treatment with BRILINTA led to a greater reduction in the primary end point - a composite of CV death, MI, or stroke - compared to patients who received clopidogrel [9.8% vs. 11.7% at 12 months, 1.9% absolute risk reduction (ARR), 16% relative risk reduction (RRR), 95% CI, 0.77 to 0.92, p