Brilinta significantly reduces CV events and coronary death beyond one year in heart attack survivors with multi-vessel disease

AstraZenecaAstraZeneca today 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) (HR 0.81; 95% CI, 0.7-0.95) and of 36% in coronary death (HR 0.64; 95% CI, 0.45-0.89) 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). (1)

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.(1) 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.(1) Findings suggest this high-risk population may benefit from extended, preventative anti-platelet therapy beyond the initial 12-month post-event period.(1)

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.(3)

Dr. Marc P. Bonaca, MD, MPH, 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."

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.(1)

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases (CVMD), 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."(2,4)

About Brilinta (ticagrelor)

Brilinta is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines(CPTPs). Brilinta works by inhibiting platelet activation and has been shown to reduce the rate of atherothrombotic CV events, such as heart attack or CV death, in patients with acute coronary syndromes (ACS).

Brilinta, co-administered with aspirin, also known as acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with ACS, or for patients with a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.

About PEGASUS-TIMI 54

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome - Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca’s largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. It was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women's Hospital (Boston, MA, USA). PEGASUS-TIMI 54 was the pivotal study from which Brilinta gained regulatory approval in its indication for the long-term prevention of CV death, heart attack and stroke for patients with a history of heart attack.

About AstraZeneca in Cardiovascular, Renal & Metabolic Diseases (CVMD)

Cardiovascular, renal and metabolic diseases together form one of AstraZeneca's main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMDs and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVMD health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

1. Bansilal S, Bonaca MP, Cornel JH, et al. Use of ticagrelor for secondary prevention of atherothrombotic events in patients with multivessel coronary disease. J Am Coll Cardiol. 2018:71; 489-96
2. Bonaca MP, Storey RF, Theroux P, et al. Efficacy and safety of ticagrelor over time in patients with prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017:70; 1368-75
3. Varenhorst C, Hasvold P, Johansson S et al. Culprit and nonculprit recurrent ischemic events in patients with myocardial infarction: Data from SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies). J Am Heart Assoc. 2018:7; e007174
4. Dellborg M, et al. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Abstract P3670. ESC Congress 2017. Last accessed January 2018

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