New data from real world evidence indicates need for better secondary prevention to reduce long-term ischaemic risk in heart attack survivors

Latest research highlights patients most at risk of future cardiovascular events


28 August 2018, 14:00 CET

New data from three real-world evidence studies (PRECLUDE-2, TIGRIS and ATHENA), are presented today at the ESC Congress 2018 in Munich, Germany. The studies, supported by AstraZeneca, underline the ongoing and persistent risk of recurrent cardiovascular (CV) events and death in patients with diabetes or who have survived a heart attack.

The TIGRIS study highlights that even in patients with stable coronary artery disease (CAD), the risk of recurrent CV events remains constant over time1. These findings are consistent with the landmark analysis of the PEGASUS-TIMI 54 trial in which patients who had suffered an MI one to three years prior and who had additional risk factors, experienced a linear accumulation of CV events (CV death, MI or Stroke) during the follow-up period of three years.2

PRECLUDE-2, a Swedish registry study involving more than 100,000 patients, found that the majority of post-MI patients who have at least two cardiovascular disease risk factors, showed a marked but gradual increase in incidence of cardiovascular death, MI or stroke.3 If all five cardiovascular risk factors studied were present, there was up to a nine-fold increase in incidence of CV events, compared to when only one risk factor was present.3

Danilo Verge, Vice President, Medical Affairs, Cardiovascular, Renal and Metabolism at AstraZeneca, said: “An estimated seven million people worldwide experience a potentially fatal heart attack every year. For those who survive, it is often the start of a journey into declining cardiovascular health. Results from PRECLUDE-2 study demonstrate that long-term CV risk is particularly pronounced for heart attack survivors with additional risk factors. These findings can help physicians identify patients who are most likely to benefit from secondary prevention therapies.”

The cardiovascular risk in patients with type-2 diabetes specifically is investigated further in the ATHENA study involving more than 300,000 patients. The results demonstrate that diabetic patients who also have CAD, or who have experienced a prior heart attack or a stroke, are at greater risk of future cardiovascular death, heart attack and stroke than patients with just diabetes alone.4 The increased risk was primarily due to an increased risk of myocardial infarction, highlighting a need for better secondary prevention therapies in these patients.

The studies, supported by AstraZeneca, and presented at ESC Congress 2018 this year highlight our continued commitment to supporting the generation of new scientific evidence and pursuing our aim of delivering leading science that addresses patient needs across the global burden of these conditions.

Below, please find more detailed information on the studies.

*please see “Note to Editors” for complete study details


Study population

Key findings

PRECLUDE-2: Registry / observational study3


·     More than 100,000 patients from the SWEDEHEART Patient Registry who had been hospitalised for a heart attack and managed invasively.

·     The majority of patients had at least two risk factors for future CV events, with greater numbers of risk factors resulting in greater risk.


·     More than 20,000 patients (20.6 percent) experienced either another heart attack, stroke or CV death during a median follow-up of 3.6 years.3


TIGRIS1: Global prospective registry study involving 369 centres in 25 countries


·       More than 9,000 high-risk stable coronary artery disease (CAD)  patients with at least one of the following risk factors aged 65 years or over, diabetes mellitus, a second prior MI, multi-vessel CAD, chronic kidney dysfunction (CKD), were.evaluated for long-term progression of atherothrombotic disease.


·     6.9 percent of patients had a recurrent CV event (MI, unstable angina with urgent revascularisation, stroke, or death from any cause) over two years with a linear accumulation of events throughout follow-up period.

·     The presence of risk factors including diabetes and an additional prior MI were independently associated with increased risk of CV events.


ATHENA4: Swedish National Registry observational study


More than 300,000 patients with type-2 diabetes treated with glucose-lowering drugs between 2006–2013.

Patients with diabetes who also have CAD, or who have experienced a prior heart attack or a stroke, are at greater risk of a future cardiovascular death, heart attacks or strokes than patients with just diabetes alone (2 years cumulative incidence 9.94% vs 6.26% vs. 4.55%). The higher risk seen in diabetic patients with CAD vs. without CAD was primarily driven by the risk of MI.



PRECLUDE (Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI) was a observational cohort study that combined the SWEDEHEART registries RIKS-HIA (Registry of Information and Knowledge about Swedish Heart Intensive care Admissions), SCAAR (Swedish Coronary Angiography and Angioplasty Registry) and SEPHIA (the registry for secondary prevention following coronary intensive care); and the Swedish National Population Registry (to obtain data regarding vital status and date of death), Swedish Cause of Death Register (to separate fatal from non-fatal MI), the Swedish Patient Registry (to obtain data on prior medical history) and the Swedish Drug Registry (to obtain prescribed medical treatment and filled prescriptions).5

The RIKS-HIA database covers all acute coronary syndrome (ACS) patients treated at heart intensive care units in Sweden and SCAAR entails all PCI procedures performed across all centres in Sweden.5

The study included patients with first-time-ever ACS events and received care at cardiac intensive care units and entered in the SWEDEHEART quality registry between 1 July 2006 and 31 December 2014. Baseline and in-hospital characteristics were noted, including peri-procedural anti-thrombotic treatments.5


TIGRIS (The long-Term rIsk, clinical manaGement and healthcare Resource utilisation of stable coronary artery dISease in post myocardial infarction patients) study was designed as a global prospective registry to evaluate the clinical management, quality of life, and outcomes in up to three-year follow-up in high-risk patients with stable coronary artery disease (CAD), one to three years post-myocardial infarction (MI), in different regions worldwide.6

The primary objective of TIGRIS is to evaluate clinical events (time to first occurrence of any event from the composite cardiovascular (CV) endpoint of MI, unstable angina with urgent revascularisation, stroke, or death from any cause), and healthcare resource utilisation associated with hospitalisation for these events, and the incidence of bleeding events, during follow-up. Overall, 9,225 patients were enrolled between June 2013 and November 2014 and were followed in 369 different centres worldwide.6


ATHENA is a Swedish nationwide registry study designed to compare cardiovascular disease (CVD) risk in type-2 diabetes patients with either: a prior MI or stroke, with CAD but without prior MI or stroke, or without CAD, prior MI or stroke. All Swedish patients with type-2 diabetes, treated with glucose-lowering drugs between 2006–2013 were enrolled.4

About AstraZeneca in Cardiovascular, Renal & Metabolism
Cardiovascular, renal and metabolism is 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 these diseases and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CVRM 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, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 

For more information, please visit and follow us on Twitter @AstraZeneca.


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1Brieger, D. et al. Linear ongoing risk of major cardiovascular events in a global prospective registry of high-risk patients with stable coronary disease: insights from the TIGRIS study[abstract]. ESC Congress; 2018 Aug 25-29; München, Germany.

2 Bonaca M.P. et al. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med 2015; 372(19):1791–800.

3 Lindholm, D. et al. Association of key risk factors and their combinations on ischemic outcomes and bleeding in patients with invasively managed myocardial infarction in Sweden[abstract]. European Society of Cardiology Congress; 2018 Aug 25-29; München, Germany

4 Jernberg, T. et al. Cardiovascular outcomes in type 2 diabetes patients: impact of prior acute cardiac event or stroke vs. coronary artery: a Swedish nationwide observational study abstract European Society of Cardiology Congress; 2018 Aug 25-29; München, Germany.

5 Pattern of Repeat Cardiovascular Events During Follow-up After First Diagnosed Event-MI (PRECLUDE-MI): U.S. National Library of Medicine; 2017 [cited 2018 Jul 17]. Available from: URL:
6 Westermann, D. et al. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post myocardial infarction patients (TIGRIS) study. ClinCardiol. 2017;40:1197-1204.