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All ASPIRIN SUMMARIES

ISSUE 2022 (20)

Aspirin Summaries Issue 20 : Aspirin and Diabetes Mellitus

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Aspirin Summaries Issue 20 : Neurology update – aspirin and stroke

An ischaemic stroke is caused by a blockage to one of the arteries in the brain due to a blood clot. Guidelines support immediate antiplatelet therapy, with aspirin, to help prevent the formation of new clots and improve recovery and outcomes after a stroke1.

A major concern and consequence of stroke is long term disability which is linked to poor prognosis and quality of life as well as a high cost to society 2. Reducing the risk of recurrent stoke is an important objective for acute stroke management as this will reduce the level of overall disability experienced3.

Aspirin has been shown to reduce the risk of recurrent disabling stroke in the first 3 months following a TIA or ischaemic stroke4 and is a vital part of acute stroke or TIA management.

The summaries below look at current research articles in stroke management including the safety and efficacy of dual antiplatelet regimens.

References

1. Minhas JS, Chithiramohan T, Wang X et al. Oral antiplatelet therapy for acute ischaemic stroke. Cochrane Database of Systematic Reviews 2022, Issue 1. Art. No.: CD000029. Doi:10.1002/14651858.CD000029.pub4

2. Wang Y, Pan Y, Li H et al. Efficacy and safety of ticagrelor and aspirin in patients with moderate ischemic stroke. An exploratory analysis of the THALES randomised clinical trial. JAMA Neurol. 2021;78(9):1091-1098. Doi:10.1001/jamaneurol.2021.2440

3. Amarenco P, Denison H, Evans SR et al. for the THALES Steering COMMITTEE and Investigators. Ticagrelor added to aspirin in acute ischemic stroke or transient ischemic attack in prevention of disabling stroke. A randomized clinical trial. JAMA Neurol. 2021;78(2):177-185. doi:10.1001/jamaneurol.2020.4396

4. Rothwell PM, Algra A, Chen Z et al. Effects of aspirin on risk and severity of early recurrent stroke after transient ischaemic attack and ischaemic stroke: time course analysis of randomised trials. Lancet. 2016;388(10042):365-375. Doi:10.1016/S0140-6736(16) 30468-8

 

Oral antiplatelet therapy for acute ischaemic stroke – Cochrane Library

The purpose of this Cochrane review was to compare the efficacy and safety of antiplatelet therapy, such as aspirin, with placebo in the acute management of an ischaemic stroke in order to see if it reduced mortality and improved long-term outcomes. The aim of antiplatelet therapy is to reduce the amount of damage to the brain and reduce the risk of a recurrent stroke. The concern is that antiplatelet therapy could increase the risk of an intracranial haemorrhage which could result in death or disability.

The authors included 11 studies, with a total of 42,226 participants, conducted before August 2020 in the review. There was an equal mix of males and females, and a significant proportion of the participants were over 70 years. Most of the evidence included in the review was from aspirin studies.

The results show that aspirin (160-300 mg daily) if started within 48 hours of stroke symptoms reduced the risk of a recurrent ischaemic stroke within the first two weeks and reduced death rates and dependency levels. They also found a benefit if aspirin was started later than 48 hours but within two weeks. This was achieved without a major risk of bleeding in the brain.

 

The author states:

‘For every 1000 people treated with aspirin, 13 people would avoid death or dependency (number needed to treat for an additional beneficial outcome 79).’

For further information please see:

Minhas JS, Chithiramohan T, Wang X et al. Oral antiplatelet therapy for acute ischaemic stroke. Cochrane Database of Systematic Reviews 2022, Issue 1. Art. No.: CD000029. doi:10.1002/14651858.CD000029.pub4

 

Dual antiplatelet therapy (DAPT) for acute stroke – Ticagrelor added to aspirin

This evaluation of data from the Acute Stroke or Transient Ischaemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial aims to compare ticagrelor plus aspirin with aspirin alone for reducing disabling recurrent stroke after an acute stroke or transient ischaemic attack (TIA).

The 11,016 participants with a noncardioembolic, nonsevere ischaemic stroke or high-risk TIA were randomised to receive either ticagrelor, at a loading dose of 180 mg within 24 hours of symptom onset and 90 mg twice daily thereafter, or placebo. All the participants were given aspirin at a dose of 300-325 mg on day 1 and 75-100 mg daily thereafter.

The results showed that ticagrelor plus aspirin significantly lowered the risk of recurrent stroke or death over the next 30 days (4.0% vs 4.7%) and this combination treatment also reduced the total disability burden. The number needed to treat (NNT) to reduce the risk of disabling stroke and death was 133.

The authors conclude:

‘In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.’

For further information please see:

Amarenco P, Denison H, Evans SR et al. for the THALES Steering COMMITTEE and Investigators. Ticagrelor added to aspirin in acute ischemic stroke or transient ischemic attack in prevention of disabling stroke. A randomized clinical trial. JAMA Neurol. 2021;78(2):177-185. doi:10.1001/jamaneurol.2020.4396

 

Efficacy and safety of DAPT for people with moderate ischaemic stroke

This post-hoc exploratory analysis of the THALES trial seeks to understand if aspirin plus ticagrelor for DAPT is beneficial to people who suffered a moderate acute ischaemic stroke. The authors explain that strokes of more moderate severity have a higher risk of poor outcomes when compared with those of lower severity and finding ways to manage this in the acute setting is therefore of interest.

The investigators found that although people who have a moderate ischaemic stroke (NHSS score 4 or 5) have a higher risk of recurrent stroke or death when compared with those who have had a less severe ischaemic event (NHSS score 0-3) the efficacy and safety of ticagrelor added to aspirin was similar. In this analysis of THALES, the primary efficacy outcome of time to recurrent stroke or death in the first 30 days, in those with an NHSS score of 4-5, had an event rate of 7.6% (129 of 1671) in the ticagrelor plus aspirin group and 9.1% (150 out of 1641) in the aspirin and placebo group. In the lower severity group (NHSS 0-3) the event rate was 4.7% (158 of 3359) in the DAPT group and 5.7% (190 out of 3312) in the aspirin plus placebo group. In the moderate stroke group severe bleeding occurred in 8 patients (0.5%) in the DAPT group and 4 patients (0.2%) in the aspirin plus placebo group. For those with less severe stroke 16 patients (0.5%) had a severe bleeding event in the DAPT group, and 3 patients (0.1%) experienced one in the aspirin plus placebo group. The dual combination therapy is therefore beneficial in both groups, being both safe and effective, and able to reduce the risk of a further disabling stroke.

The authors suggest that:

‘Patients with a moderate ischemic stroke had consistent benefit from ticagrelor plus aspirin vs aspirin alone compared with patients with less severe ischemic stroke, with no further increase in the risk of intracranial bleeding or other severe bleeding events.’’

For further information please see:

Wang Y, Pan Y, Li H et al. Efficacy and safety of ticagrelor and aspirin in patients with moderate ischemic stroke. An exploratory analysis of the THALES randomised clinical trial. JAMA Neurol. 2021;78(9):1091-1098. Doi:10.1001/jamaneurol.2021.2440

 

A meta-analysis of RCTs for DAPT versus aspirin in patients with stroke or TIA

This systematic review and meta-analyses looked at the efficacy and safety of DAPT versus aspirin alone after stroke or TIA. The primary safety outcome was risk of recurrent stroke, and the primary safety outcome was risk of bleeding. Secondary outcomes included risk of ischaemic stroke, haemorrhagic stroke, major cardiovascular events and all cause death.
The meta-analyses included four randomised controlled trails (FASTER 2007, CHANCE 2013, POINT 2018 and THALES 2020) and 21,459 patients. The first 3 of these trials use aspirin plus clopidogrel for DAPT and THALES uses aspirin with ticagrelor.

They found that DAPT resulted in a lower risk of recurrent stroke (RR, 0.76 [95% CI,0.68-0.83]; P<0.001; I2=0%), and a lower risk of major cardiovascular events and recurrent ischaemic events but that this was countered by a higher bleeding risk (RR, 2.22 [95% CI, 1.14-4.34], P=0.02, I2 =46.5%) when compared with aspirin alone.

The number needed to treat (NNT) to prevent an additional ischaemic stroke, using aspirin plus clopidogrel ranged from 21-58 and 78 when using DAPT with ticagrelor compared with aspirin monotherapy. The number needed to harm with a major bleeding event was between 40-186 in the FASTER and POINT trials for aspirin and clopidogrel patients and 221 for aspirin with ticagrelor in THALES. In CHANCE patients taking aspirin and clopidogrel had a lower bleeding event rate than the aspirin monotherapy arm. Overall, the absolute benefits of DAPT appear to be greater than the increased risk of bleeding.

The authors state:

“As compared to aspirin alone, short-term DAPT within 24 hours of high-risk transient ischemic attack or mild-moderate ischemic stroke reduces the risk of recurrent stroke at the expense of higher risk of major bleeding.”

For further information please see:

Bhatia K, Jain V, Aggarwal D et al. Dual antiplatelet therapy versus aspirin in patients with stroke or transient ischemic attack: meta-analysis of randomized controlled trials. Stroke. 2021. 52(6); e217-e233. https://doi.org/10.1161/STROKEAHA.120.033033

 

The impact of blood pressure control with DAPT for reducing recurrent stroke

In this post hoc analysis of 4781 participants from the POINT trial the investigators found that patients with a systolic blood pressure (BP) of less than 140 mm Hg benefitted more from 90 days of DAPT particularly in terms of recurrent stroke reduction than those with a systolic baseline BP of over 140 mmHg. Patients with a baseline systolic BP of 140 mm Hg or less taking DAPT had a reduced risk of recurrent stroke of 64% within 90 days of the first event compared with aspirin alone. However, if they had a baseline BP of more than 140 mm Hg no benefit for DAPT was found.

This, however, differs from findings in the CHANCE trial, where a significantly lower risk of recurrent stroke was only found in patients taking DAPT with a baseline systolic BP of 140 mm Hg or more

The authors conclude:

“Additional research is needed to replicate our findings and potentially test whether mild SBP reduction and DAPT within 12 hours of stroke lowers early risk of stroke recurrence.”

For further information please see:

De Havenon A, Johnston C, Easton D et al. Evaluation of systolic blood pressure, use of aspirin and clopidogrel, and stroke recurrence in the platelet-oriented inhibition in new TIA and minor ischemic stroke trial. JAMA Network Open. 2021:4(6): e2112551. Doi:10.1001/jamanetworkopen.2021.12551

 

Disclaimers:

• The information, views and opinions expressed are not endorsed or approved by members of The Scientific Advisory Board unless otherwise stated.
• The Information section is compiled using current published information at the time of writing and whilst every effort has been made to avoid errors, professional clinical judgement is required to interpret the information given.  The information given is referenced clearly for further analysis as required.
• Every effort is made by the International Aspirin Foundation to see that no misleading or inaccurate data, statement or opinion appear. The International Aspirin Foundation cannot be held responsible for any errors or for any consequences arising from the use of the information.
• The International Aspirin Foundation, its associates and The Scientific Advisory Board accept no liability whatsoever for the consequences of any such inaccurate or misleading data, information, opinion or statement.
• Any information involving drug usage, should only be followed in conjunction with the drug manufacturer’s own published literature in their own country.
• Medical sciences evolve on a continual basis and therefore independent verification of the content should be made.
• The information, views, opinions and any other material provided should not be relied upon as a substitute to professional medical advice in relation to any medical condition. The International Aspirin Foundation, its associates and The Scientific Advisory Board accept no liability whatsoever for any consequences arising from any reliance placed on such information, views, opinions and other materials in lieu of professional medical advice.

 

 

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Daniel José Piñeiro

ASSOCIATE
Name
Daniel José Piñeiro
Academic Affiliations:
Full Professor of Medicine, Universidad de Buenos Aires, Argentina Trustee, Board of Trustees, American College of Cardiology
Professional Setting:
My academic experience includes more than 40 years as a practicing medical doctor, teacher, and researcher. I have fulfilled these appointments in settings of vital social engagement and impact, most notably at the Hospital de Clínicas “José de San Martín” of the Universidad de Buenos Aires, a public hospital with high academic recognition. Additionally, I currently hold the position of Full Professor of Medicine at that same University.
Academic Activities:
  • International Meetings Participations: 180
  • Books-Editor: 1
  • Books Chapters: 39
  • Refereed Full Articles: 118 (listed in Pubmed: 29)
  • Refereed Abstracts: 221
  • Editorial Boards: 10
Profesional Associations:
  • 2005 President, Sociedad Argentina de Cardiología.
  • 2011-2013 President, Inter-American Society of Cardiology.
  • 2011-2013 Member (ex-officio), Board of Directors, World Heart Federation
  • 2017-2018 Member (at large), Board of Directors, World Heart Federation
  • 2018-2021 Trustee, Board of Trustees, American College of Cardiology
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Chia

John Chia

Name
John Chia MBBS (Spore), MRCP (UK), FAMS (Spore)
Academic Affiliations:

Adjunct Associate Professor DUKE-NUS Graduate Medical School,
Consultant Oncologist Curie Oncology Singapore,
Visiting Consultant National Cancer Centre Singapore.

Discipline:

Medical Oncology

Scientific Interests:
  • Aspirin as adjuvant therapy in established cancers
  • Adoptive T cell therapy and Dendritic cell vaccines in the treatment of solid tumors
  • Clinical Trial Design and Management
Declaration of Conflicts of Interest:

In the past 3 years, I have received consultant fees from Tessa Therapeutics, Aslan Pharmaceuticals, Novartis, and AstraZeneca.

I received grant support for investigator-initiated research from:

  • National Medical Research Council Singapore
  • Bayer AG

I hold shares in:  Roche, BMS, AstraZeneca, Incyte, Teva Pharmaceuticals, Trillium Therapeutics, Compugen, Arrowhead pharmaceuticals, Emergex, QuantumDx and Halozyme Therapeutics

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Badimon

Lina Badimon

Name
Lina Badimon BSc, PharmD, PhD, FESC, FAHA
Academic Affiliations:
Director of the Cardiovascular Science Program (ICCC) at the Hospital Santa Creu and San Pau, IIB-Sant Pau; CIBER CV. Director of the Cardiovascular Research Chair of the Autonomous University of Barcelona and Director of the UNESCO Chair in Biomedical Sciences Training and Research.
Discipline:
Pharmacology, Cardiovascular Disease
Scientific Interests:
Cardio-metabolic diseases, thrombosis, atherosclerosis and ischemic heart disease
Declaration of Conflicts of Interest:

I received consultant and speakers fees from Amgen, AstraZeneca, Bayer, Lilly and Sanofi.

    Return to Scientific Advisory Board
    Ge

    Junbo Ge

    Name

    Junbo Ge

    Ge Junbo, male, was born in Wulian, Shandong province on Nov. 8, 1962. He is the member of Chinese Academy of Sciences, professor and doctoral supervisor. He received his doctor’s degree of Medicine from German Mayence University in 1993 and now works as the director for Shanghai Institute of Cardiovascular Disease and the Center for Stem Cells and Tissue Engineering, Fudan University. He is also the designate chairman of the Cardiovascular Disease Branch of Chinese Medical Association, council member of the Cardiovascular Angiography and Interventions Association, international consultant of the American Heart Association. In Dec. 2013, he was appointed as the vice president of Tongji University.

    Prof. Ge has been engaged in clinical and scientific research work of cardiovascular disease since 1987, and his research area covers the pathogenesis of coronary heart disease, early diagnosis and treatment plan optimization.

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    Langley

    Ruth Langley

    Name
    Ruth Langley PhD, FRCP
    Academic Affiliations:
    Professor of Oncology and Clinical Trials, MRC Programme Leader and Chair of the Cancer Group, MRC Clinical Trials Unit at UCL, honorary consultant in medical oncology at the Brighton and Sussex University Hospital.
    Discipline:
    Medical oncologist; trialist
    Scientific Interests:
    • Aspirin
    • Gastro-oesophageal malignancy
    • Transdermal oestrogen in the treatment of prostate cancer
    • Trials methodology
    Declaration of Conflicts of Interest:
    Has received honorarium from Bayer
    Return to Scientific Advisory Board
    Chan

    Andrew T Chan

    Name
    Andrew T. Chan MD, MPH
    Academic Affiliations:
    Chief, Clinical and Translational Epidemiology Unit, Vice Chair, Division of Gastroenterology, Massachusetts General Hospital, Boston, Co-leader, Cancer Epidemiology Program, Dana-Farber/Harvard Cancer Center, Boston.
    Discipline:
    Gastroenterology
    Scientific Interests:
    • The role of aspirin in the prevention of colorectal cancer and other cancers
    • The role of the gut microbiome in colorectal cancer and other chronic gastrointestinal diseases, including inflammatory bowel disease and diverticulitis
    • The role of diet and lifestyle in colorectal cancer and other chronic gastrointestinal cancers
    Declaration of Conflicts of Interest:

    AACR Honors Dr. Andrew T. Chan With 2019 AACR-Waun Ki Hong Award

    Click here to find the press release.

    I received consultant Bayer and Pfizer, Inc.

    I received grant support for investigator-initiated research from:

    • National Institutes of Health
    • National Cancer Institute
    • Crohn’s and Colitis Foundation
    • Bayer AG
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    Gaziano

    Mike Gaziano

    Name
    J Michael Gaziano MD, MPH
    Academic Affiliations:

    Professor of Medicine, Harvard Medical School; Chief Division of Aging, Brigham and Women’s Hospital; Director of Preventive Cardiology and Director of Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System.
    Discipline: Cardiology and Epidemiology

    Scientific Interests:
    I am a chronic disease epidemiologist with a particular interest in the roles that individual lifestyle choices (diet, exercise, smoking), metabolic factors (obesity, high cholesterol, and hypertension), and biochemical and genetic markers play on the risk of cardiovascular disease and other chronic illnesses. Also, of interest is the impact that vascular disease has on other organ systems, including cognitive dysfunction and renal disease. I have an interest in the design of large-scale trials and observational studies nested in large health care systems using big data analytic techniques.
    Declaration of Conflicts of Interest:

    I received consultant and speaker fees Bayer.

    I received grant support as a principal investigator or co-investigator for research from the VA, DOD, NIH, Merck and Kowa.

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    Pierre A Web Photo

    Pierre Amarenco

    Name

    Pierre Amarenco, MD, FAHA, FAAN

    Academic Affiliations:
    • Professor of Neurology at Paris-Diderot Sorbonne University 
    • Chairman of the Department of Neurology and Stroke Center; Bichat University Hospital
    • Co-Director INSERM Unit-698 “Clinical Research in Atherothrombosis”
    Discipline:

    Neurology and Vascular Neurology

    Scientific Interests:
    • Understanding and preventing stroke and vascular diseases
    • Clinical trials in prevention of vascular diseases
    • Carotid intima-media thickness studies
    • Lipid trials: prevention and therapeutic –protective- evaluation
    Declaration of Conflicts of Interest:

    N/A

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    CarloPatrono

    Carlo Patrono

    CHAIR
    Name
    Carlo Patrono MD, FESC, FRCP
    Academic Affiliations:
    Adjunct Professor of Pharmacology at the Catholic University School of Medicine in Rome (Italy) and at the Perelman School of Medicine of the University of Pennsylvania in Philadelphia (USA).
    Discipline:
    Clinical Pharmacology
    Scientific Interests:
    • Studying platelet activation and inhibition in diabetes mellitus
    • Studying platelet activation and inhibition in myeloproliferative neoplasms
    • Investigating the mechanism of action of low-dose aspirin in preventing colorectal cancer
    Declaration of Conflicts of Interest:

    I received consultant and speakers fees from Acticor Biotech,  Amgen,  Bayer, GlaxoSmithKline,  Tremeau,  Zambon.

    I received grant support for investigator-initiated research from:

    • AIFA (Italian Drug Agency)
    • Bayer AG
    • Cancer Research UK
    • European Commission, FP6 and FP7 Programmes

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