Results were achieved without an increase in major bleeding compared to clopidogrel
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The new data from the phase III PLATO study showed that AstraZeneca’s BRILINTA (ticagrelor) provided reduction of cardiovascular (CV) events than clopidogrel (9.02% vs 10.65%, p=0.0025 a 16% Relative Risk Reduction) in acute coronary syndromes patients undergoing planned invasive treatment (either PCI or CABG).
The company claims that patients undergoing invasive procedures are at greater risk of bleeding, the results were achieved without an increase in major bleeding compared to clopidogrel (11.5% vs 11.6%, p=0.88). Patients with planned invasive procedures at randomisation accounted for more than 70% of the greater than 18,000 patients in PLATO.
Additional findings from the PLATO invasive sub-analysis showed that treatment with BRILINTA, compared to clopidogrel, demonstrated an effect consistent with the results for the entire PLATO population across the multiple secondary efficacy endpoints. The effect was seen regardless of whether a standard 300mg loading dose of clopidogrel was given, or an additional loading dose of clopidogrel (eg 600mg) was given. Results in the sub-group analysis indicated treatment with ticagrelor was found that it reduced CV death 3.4% vs 4.3% (p=0.025), a relative risk reduction of 18%.
It reduced myocardial infarction 5.3% vs 6.6% (p=0.002), a relative risk reduction of 20% and reduces definite stent thrombosis 1.0% vs 1.6% (p=0.003) a relative risk reduction of 38%. It also reduced total mortality 3.9% vs 5.1% (p=0.01) a relative risk reduction of 19%.
The PLATO study was designed to reflect how patients with ACS are currently managed in clinical practice, by including patients who underwent invasive procedures and those who were managed with medication only.
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