AstraZeneca has announced results from a new sub-analysis of the Phase III PEGASUS-TIMI 54 trial, demonstrating a risk reduction of 19% in MACE (the composite of CV death, myocardial infarction, or stroke) and of 36% in coronary death from treatment with Brilinta 60mg (ticagrelor), in combination with low dose aspirin, in people who had survived a heart attack and had stenosis (abnormal narrowing) in two or more coronary blood vessels, a condition known as multi-vessel disease (MVD).
This pre-specified sub-analysis is published in the Journal of the American College of Cardiology.
MVD was defined as the presence of >50% abnormal narrowing in two or more coronary blood vessels at the time of the first heart attack. The results could have implications for the continued treatment of heart attack survivors, as a majority of the 21,162 trial participants (12,558 (59.4%)) presented with MVD.
Findings suggest this high-risk population may benefit from extended, preventative anti-platelet therapy beyond the initial 12-month post-event period.
This sub-analysis also highlights the increased risk of cardiac events among people with MVD who have already experienced a heart attack.
The data add to recently published real-world evidence from the SWEDEHEART quality registry, showing the persistency of risk and the importance of effective secondary prevention medication to reduce the risk of further heart attacks as a result of occluded arteries that were not stented.
The use of Brilinta was associated with an increased risk of major bleeding (as defined by the TIMI bleeding criteria) compared with aspirin alone, which was consistent with the overall findings seen in PEGASUS-TIMI 54. There was no increased risk of intracranial haemorrhage or fatal bleeding.
Dr Marc P. Bonaca, of Brigham and Women’s Hospital and the TIMI Study Group, and PEGASUS-TIMI 54 trial investigator, said: “The role of effective anti-platelet therapy in reducing the risk of further coronary events in high-risk patients is already well establised. What this new analysis suggests is that treatment with Brilinta has the potential to deliver greater absolute risk reductions in higher risk populations such as those with MVD.”
Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: “These results show that for patients with multi-vessel disease who have survived a heart attack and remain at risk of suffering a potentially deadly follow-on event, the extended use of Brilinta offers added protection. These data build on evidence from other recent analyses of PEGASUS-TIMI 54 that reinforce the key role Brilinta can play in reducing the long-term risk of CV events among high-risk patient populations.”