Results indicate Brilinta 90mg (ticagrelor) may be suitable treatment option in high-risk heart attack patients treated with pharmacological thrombolysis
Phase 3 study presented as official Late Breaker during American College of Cardiology’s Annual Scientific Session and simultaneously in JAMA Cardiology
11 March 2018 [08:00 GMT-4]
AstraZeneca today announced initial results from TREAT (Ticagrelor in Patients With ST Elevation Myocardial Infarction (STEMI) Treated With Pharmacological Thrombolysis), a Phase III, investigator-initiated and academically-led trial, financially supported by AstraZeneca, investigating the safety of ticagrelor 90mg compared to clopidogrel 75mg in heart attack patients treated with pharmacological thrombolysis.[i] The results, presented at the American College of Cardiology’s 67th Annual Scientific Session in Orlando, demonstrate comparable safety profiles in thrombolysed STEMI patients, as measured by major bleeding at 30 days, between ticagrelor and clopidogrel (P<0.001 for non-inferiority).1
An estimated seven million people experience a heart attack (also known as a myocardial infarction or MI) every year,[ii] yet many will not have timely access to primary percutaneous coronary intervention (pPCI) – a procedure to unblock damaged blood vessels to prevent further potentially deadly heart attacks, but which can only be undertaken in a specialist hospital setting. For these high-risk patients, pharmacological thrombolysis (blood thinning) is recommended by medical guidelines as an alternative therapy to reduce risk by breaking down clots in the affected vessels.[iii],[iv]
Dr. Otavio Berwanger, chair of the TREAT study steering committee, said: “Millions of people have a heart attack each year, and how they are treated in the immediate period that follows has huge implications on patient outcomes. Although pPCI is considered the gold standard, thrombolysis is also an effective alternative and commonly used treatment strategy, and due to the previous lack of safety data for ticagrelor in this population, many patients are currently limited to clopidogrel alongside thrombolytic therapy. With the latest ESC guidelines4 also indicating a potential role for potent P2Y12 therapy for these high risk STEMI patients, the TREAT safety data has the potential to be practice changing.”
TREAT is a randomised, multicentre, open-label, non-inferiority trial involving 3,801 patients, comparing the use of ticagrelor 180mg (followed by 90 mg twice daily for 12 months) versus clopidogrel 300 mg (followed by 75mg/day for 12 months), both administered as early as
possible within a maximum of 24-hours following the initial heart attack.[v] The initial study results showed that in patients aged < 75 years whose STEMI heart attack was treated with thrombolytic therapy, ticagrelor was non-inferior to clopidogrel for major bleeding at 30 days (P<0.001 for noninferiority).1 Rates of major cardiovascular events were similar between ticagrelor and clopidogrel at 30 days, although due to the low number of events, statistical power to assess superiority was limited.1 Further assessment of safety and efficacy is planned at 12 months.5
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, AstraZeneca, said: “The results of TREAT are significant, with the potential to open-up ticagrelor as a therapeutic option for patients undergoing thrombolytic therapy due to the unavailability of pPCI in the immediate hours following a heart attack.”
NOTES TO EDITORS
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 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.
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. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
[i] Berwanger O, Nicolau JC, Carvalho AC et al. Ticagrelor versus clopidogrel in patients with ST Elevation myocardial infarction treated with fibrinolytic therapy. Late-breaking clinical trials session, American College of Cardiology, 67th Annual Scientific Session and Expo, Orlando FL, March 10-12 2018.
[iii] O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA Guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.
[iv] Ibanez B, James S, Agewall S et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2017 Aug 26. doi: 10.1093/eurheartj/ehx393. [Epub ahead of print]
[v] ClinicalTrials.gov. Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis (TREAT). Available at: https://clinicaltrials.gov/ct2/show/NCT02298088 Last accessed March 2018.