aspirin

Aspirin for Primary Atherosclerotic Cardiovascular Disease Prevention as Baseline Risk Increases: A Meta-Regression Analysis

anticoagulant therapy

treatment

heart-valve replacement

thrombosis

PMID (1):

33871544

MeSH

Patients at risk for thrombotic events almost never require the combination of a DOAC and low-dose aspirin. Those taking both are at significantly increased risk of bleeding and no reduction in thrombosis. James W. Mold, MD, MPH

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Importance: It is unclear how many patients treated with a direct oral anticoagulant (DOAC) are using concomitant acetylsalicylic acid (ASA, or aspirin) and how this affects clinical outcomes.

Objective: To evaluate the frequency and outcomes of prescription of concomitant ASA and DOAC therapy for patients with atrial fibrillation (AF) or venous thromboembolic disease (VTE).

Design, setting, and participants: This registry-based cohort study took place at 4 anticoagulation clinics in Michigan from January 2015 to December 2019. Eligible participants were adults undergoing treatment with a DOAC for AF or VTE, without a recent myocardial infarction (MI) or history of heart valve replacement, with at least 3 months of follow-up.

Exposures: Use of ASA concomitant with DOAC therapy.

Main outcomes and measures: Rates of bleeding (any, nonmajor, major), rates of thrombosis (stroke, VTE, MI), emergency department visits, hospitalizations, and death.

Results: Of the study cohort of 3280 patients (1673 [51.0%] men; mean [SD] age 68.2 [13.3] years), 1107 (33.8%) patients without a clear indication for ASA were being treated with DOACs and ASA. Two propensity score-matched cohorts, each with 1047 patients, were analyzed (DOAC plus ASA and DOAC only). Patients were followed up for a mean (SD) of 20.9 (19.0) months. Patients taking DOAC and ASA experienced more bleeding events compared with DOAC monotherapy (26.0 bleeds vs 31.6 bleeds per 100 patient years, P = .01). Specifically, patients undergoing combination therapy had significantly higher rates of nonmajor bleeding (26.1 bleeds vs 21.7 bleeds per 100 patient years, P = .02) compared with DOAC monotherapy. Major bleeding rates were similar between the 2 cohorts. Thrombotic event rates were also similar between the cohorts (2.5 events vs 2.3 events per 100 patient years for patients treated with DOAC and ASA compared with DOAC monotherapy, P = .80). Patients were more often hospitalized while undergoing combination therapy (9.1 vs 6.5 admissions per 100 patient years, P = .02).

Conclusion and relevance: Nearly one-third of patients with AF and/or VTE who were treated with a DOAC received ASA without a clear indication. Compared with DOAC monotherapy, concurrent DOAC and ASA use was associated with increased bleeding and hospitalizations but similar observed thrombosis rate. Future research should identify and deprescribe ASA for patients when the risk exceeds the anticipated benefit.

Author/s:

Schaefer, J. K., Errickson, J., Li, Y., Kong, X., Alexandris-Souphis, T., Ali, M. A., Decamillo, D., Haymart, B., Kaatz, S., Kline-Rogers, E., Kozlowski, J. H., Krol, G. D., Shankar, S, R., Sood, S. L., Froehlich, J. B., Barnes, G. D.

Aspirin for Primary Atherosclerotic Cardiovascular Disease Prevention as Baseline Risk Increases: A Meta-Regression Analysis

John Bayhi — Thu, 21 May 2020 16:39:36 +0000

Date Added:

May 21, 2020

Journal/Publication:

The American Journal of Medicine

Publisher:

Elsevier Inc

Publication Date:

May 20, 2020

Volume:

Article in Press

URL:

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.amjmed.2020.04.028

Keywords

Atherosclerotic Cardiovascular Disease

myocardial infarction

MeSH

cardiovascular diseases

Brain Ischemia

follow-up studies

myocardial infarction

This analysis of 12 RCTs involving almost 1 million patients found that low-dose aspirin prevents major cardiovascular events (RRReduction 14%; ARR/1000 patient years 0.06%) but increases major bleeding events (RRIncrease 40%; ARR/1000 patient years 0.1%) across all levels of baseline risk. The researchers concluded that the absolute risk reduction and the risk: benefit ratio suggest that we should probably not prescribe low-dose aspirin for primary prevention even if the baseline risk of CV events is high and the risk of bleeding is low. James W. Mold, MD, MPH

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Background

Aspirin is often prescribed for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) however, recent randomized trials (RCTs) have challenged this practice. Despite this, aspirin is commonly recommended for high risk primary prevention. We tested the hypothesis that aspirin is more efficacious for the primary prevention of ASCVD, as the baseline risk increases.

Methods

RCTs that compared aspirin to control for primary prevention and evaluated ASCVD (composite of myocardial infarction and ischemic stroke) and major bleeding were included. Rate ratios (RR) and 95% confidence intervals (CI) were calculated. A regression analysis was performed using the ASCVD event rate in the control arm of each RCT as the moderator.

Results

Twelve RCTs were identified with 963,829 patient years of follow-up. Aspirin was associated with a reduction in ASCVD (4.7 versus 5.3 events per 1,000 patient years; RR 0.86; 95% CI 0.79-0.92). There was increased major bleeding among aspirin users (2.5 versus 1.8 events per 1000 patient years, RR 1.41 95% CI, 1.29-1.54). Regression analysis found no relationship between the log rate ratio of ASCVD or major bleeding and incidence of ASCVD in the control arm of each RCT.

Conclusion

Aspirin is associated with a reduction in ASCVD when used for primary prevention; however, it is unlikely to be clinically significant given the increase in bleeding. More importantly, aspirin's treatment effect does not increase as ASCVD risk increases as many hypothesize. There is no suggestion from this data that use of aspirin for higher risk primary prevention patients is beneficial.

Author/s:

Nudy, M, Cooper, J, Ghahramani, M, Ruzieh, M, Mandrola, J, Foy, AJ

Sex Difference in Effects of Low-Dose Aspirin on Prevention of Dementia in Patients With Type 2 Diabetes: A Long-term Follow-up Study of a Randomized Clinical Trial

Brian Desmarais — Mon, 09 Dec 2019 19:29:10 +0000

Date Added:

December 9, 2019

Journal/Publication:

Diabetes Care

Publication Date:

December 4, 2019

URL:

Sex Difference in Effects of Low-Dose Aspirin on Prevention of Dementia in Patients With Type 2 Diabetes: A Long-term Follow-up Study of a Randomized Clinical Trial.

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.2337/dc19-1188

Keywords

low-dose aspirin

MeSH

diabetes mellitus, type 2

And yet more information about the potential value (reduced risk of dementia) of low-dose aspirin, this time in women with Type 2 diabetes.

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OBJECTIVE:

To evaluate and compare the efficacy of long-term use of low-dose aspirin for the prevention of dementia in men and women.

RESEARCH DESIGN AND METHODS:

This study is a follow-up cohort study of the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial, which was a randomized, open-label, standard care-controlled trial examining the effects of low-dose aspirin on cardiovascular events. We followed up 2,536 Japanese patients with type 2 diabetes (T2D) enrolled in the JPAD trial from 2002 to 2017. The primary outcome of this post hoc analysis was the incidence of dementia, which was defined by the prescription of antidementia drugs or admission due to dementia.

RESULTS:

Among the originally enrolled patients, 2,121 (84%) retained their original allocation. During a median follow-up of 11.4 years, 128 patients developed dementia. The overall effect of low-dose aspirin on the prevention of dementia adjusted for age, sex, and other established risk factors was not significant (hazard ratio [HR] 0.82, 95% CI 0.58-1.16). However, a significant reduction was seen in the risk of dementia in women (HR 0.58, 95% CI 0.36-0.95), but not in men (HR 1.27, 95% CI 0.75-2.13) (P interaction = 0.03).

CONCLUSIONS:

Long-term use of low-dose aspirin may reduce the risk for dementia in women with T2D.

Author/s:

Matsumoto, C., Ogawa, H., Saito, Y., Okada S., Soejima, H., Sakuma, M., Masuda, I., Nakayama, M., Doi, N., Jinnouchi, H., Waki, M., Morimoto, T., JPAD Trial Investigators

Aspirin in the Treatment and Prevention of Migraine Headaches: Possible Additional Clinical Options for Primary Healthcare Providers

Brian Desmarais — Mon, 11 Nov 2019 15:09:25 +0000

Date Added:

November 11, 2019

Journal/Publication:

The American Journal of Medicine

Publication Date:

October 12, 2019

URL:

Aspirin in the Treatment and Prevention of Migraine Headaches: Possible Additional Clinical Options for Primary Healthcare Providers

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.1016/j.amjmed.2019.10.023

Keywords

MeSH

While the full article is not available for free, I though the abstract might be of interest and value. James W. Mold, MD, MPH

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Migraine headaches are among the most common and potentially debilitating disorders encountered by primary healthcare providers. In the treatment of acute migraine as well as prevention of recurrent attacks there are prescription drugs of proven benefit. For those without health insurance or high co-pays, however, they may be neither available nor affordable and, for all patients, they may be either poorly tolerated or contraindicated.

The totality of evidence, which includes data from randomized trials, suggests that high-dose aspirin, in doses from 900 to 1300 milligrams, taken at the onset of symptoms, is an effective and safe treatment option for acute migraine headaches. In addition, the totality of evidence, including some, but not all, randomized trials, suggests the possibility that daily aspirin in doses from 81 to 325 milligrams, may be an effective and safe treatment option for the prevention of recurrent migraine headaches.

The relatively favorable side effect profile of aspirin and extremely low costs compared with other prescription drug therapies may provide additional options for primary healthcare providers treating acute as well as recurrent migraine headaches.

Author/s:

Biglione, B., Gitin, A., Gorelick, P., Hennekens, C.

Aspirin for the Primary Prevention of Cardiovascular Disease: Weighing Up the Evidence

Jeffrey Wilson — Mon, 18 Mar 2019 14:43:45 +0000

Date Added:

March 18, 2019

Journal/Publication:

The American Journal of Medicine

Publisher:

Elsevier

Publication Date:

March 12, 2019

URL:

Aspirin for the Primary Prevention of Cardiovascular Disease: Weighing Up the Evidence

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.amjmed.2019.02.025

Keywords

PMID (1):

30871925

MeSH

cardiovascular diseases

Association of Aspirin Use for Primary Prevention With Cardiovascular Events and Bleeding Events: A Systematic Review and Meta-analysis

A nice review of the effectiveness of aspirin for primary prevention of CV events with a particular focus on the question of weight-based dosing. Bottom line is that primary prevention of CV events with aspirin, regardless of dose, is rarely justifiable.

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Aspirin is one of the most universally recognized and commonly prescribed medications worldwide. It is estimated that 48.7 million U.S. adults are taking aspirin for cardiovascular disease prevention; the majority (~73%) for primary prevention. The benefit of aspirin for secondary prevention of cardiovascular disease is well-established, with meta-analysis results favoring low dose (75–150 mg/day) over high dose (>150 mg/day) aspirin given similar efficacy but lower bleeding risk. In contrast, the role of aspirin in primary cardiovascular disease prevention is more controversial; historical trials found benefit but trials since 2008 have shown either null effects on all-cause and cardiovascular disease mortality or a signal for increased mortality in the context of excess bleeding.

Author/s:

Murphy, Sean, McCarthy, Cian P., McEvoy, John W.

Association of Aspirin Use for Primary Prevention With Cardiovascular Events and Bleeding Events: A Systematic Review and Meta-analysis

Tracy Ashby — Mon, 11 Feb 2019 06:00:00 +0000

Date Added:

February 11, 2019

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

January 22, 2019

Issue:

Volume:

321

Pages:

277-287

URL:

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2018.20578 Free full text

Keywords

bleeding events

PMID (1):

30667501

MeSH

hemorrhage

cardiovascular diseases

Consistent with the findings of the USPSTF, in adults with no history of cardiovascular disease, aspirin reduces the incidence of adverse cardiovascular events and increases the rate of major bleeding episodes. It has little or no effect on mortality.

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IMPORTANCE:

The role for aspirin in cardiovascular primary prevention remains controversial, with potential benefits limited by an increased bleeding risk.

OBJECTIVE:

To assess the association of aspirin use for primary prevention with cardiovascular events and bleeding.

DATA SOURCES:

PubMed and Embase were searched on Cochrane Library Central Register of Controlled Trials from the earliest available date through November 1, 2018.

STUDY SELECTION:

Randomized clinical trials enrolling at least 1000 participants with no known cardiovascular disease and a follow-up of at least 12 months were included. Included studies compared aspirin use with no aspirin (placebo or no treatment).

DATA EXTRACTION AND SYNTHESIS:

Data were screened and extracted independently by both investigators. Bayesian and frequentist meta-analyses were performed.

MAIN OUTCOMES AND MEASURES:

The primary cardiovascular outcome was a composite of cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke. The primary bleeding outcome was any major bleeding (defined by the individual studies).

RESULTS:

A total of 13 trials randomizing 164 225 participants with 1 050 511 participant-years of follow-up were included. The median age of trial participants was 62 years (range, 53-74), 77 501 (47%) were men, 30 361 (19%) had diabetes, and the median baseline risk of the primary cardiovascular outcome was 9.2% (range, 2.6%-15.9%). Aspirin use was associated with significant reductions in the composite cardiovascular outcome compared with no aspirin (57.1 per 10 000 participant-years with aspirin and 61.4 per 10 000 participant-years with no aspirin) (hazard ratio [HR], 0.89 [95% credible interval, 0.84-0.95]; absolute risk reduction, 0.38% [95% CI, 0.20%-0.55%]; number needed to treat, 265). Aspirin use was associated with an increased risk of major bleeding events compared with no aspirin (23.1 per 10 000 participant-years with aspirin and 16.4 per 10 000 participant-years with no aspirin) (HR, 1.43 [95% credible interval, 1.30-1.56]; absolute risk increase, 0.47% [95% CI, 0.34%-0.62%]; number needed to harm, 210).

CONCLUSIONS AND RELEVANCE:

The use of aspirin in individuals without cardiovascular disease was associated with a lower risk of cardiovascular events and an increased risk of major bleeding. This information may inform discussions with patients about aspirin for primary prevention of cardiovascular events and bleeding.

Author/s:

Zheng, Sean L., Roddick, Alistair J.

Aspirin Use in Primary Care

Tracy Ashby — Fri, 25 Jan 2019 06:00:00 +0000

Date Added:

January 25, 2019

Journal/Publication:

Healthy Hearts for Oklahoma (H2O)

Publisher:

The Oklahoma Cooperative

Publication Date:

January 25, 2019

Type:

Clinical Decision Aids

Format:

Article

Keywords

MeSH

disease, cardiovascular

Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline

This is the material used in the Healthy Hearts for OK project to update clinicians on the role of low-dose aspirin for prevention of cardiovascular events.

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An update for clinicians on the role of low-dose aspirin for prevention of cardiiovascular events from the Healthy Hearts for OK project.

Author/s:

Mold, James W.

Dual antiplatelet therapy with aspirin and clopidogrel for acute high risk transient ischaemic attack and minor ischaemic stroke: a clinical practice guideline

Tracy Ashby — Sun, 06 Jan 2019 06:00:00 +0000

Date Added:

January 6, 2019

Journal/Publication:

BMJ

Publisher:

BMJ Publishing Group Ltd

Publication Date:

December 18, 2018

URL:

Type:

Meta-analyses, Reviews, and Guidelines, Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1136/bmj.k5130

Keywords

transient ischemic attack

PMID (1):

30563885

MeSH

ischemic attack, transient

This expert panel has issued a strong recommendation for initiating dual antiplatelet therapy (e.g. aspirin plus clopidogrel) within 24 hours of the onset of symptoms of a high-risk TIA or minor ischemic stroke based upon evidence from a recent large meta-analysis.

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What is the role of dual antiplatelet therapy after high risk transient ischaemic attack or minor stroke? Specifically, does dual antiplatelet therapy with a combination of aspirin and clopidogrel lead to a greater reduction in recurrent stroke and death over the use of aspirin alone when given in the first 24 hours after a high risk transient ischaemic attack or minor ischaemic stroke? An expert panel produced a strong recommendation for initiating dual antiplatelet therapy within 24 hours of the onset of symptoms, and for continuing it for 10-21 days. Current practice is typically to use a single drug.

Author/s:

Reed A.C., Hao, Qiukui, Guyatt, Gordon H., O’Donnell, Martin, Lytvyn, Lyubov, Heen, Anja Fog, Agoritsas, Thomas, Vandvik, Per O., Gorthi, Sankar P., Fisch, Loraine, Jusufovic, Mirza, Muller, Jennifer, Booth, Brenda, Horton, Eleanor, Fraiz, Auxiliadora, Siemieniuk, Jillian, Fobuzi, Awah C., Katragunta, Neelima, Rochwerg, Bram, Prasad, Kameshwar

Aspirin Use in Primary Care

Jeffrey Wilson — Wed, 05 Sep 2018 15:37:53 +0000

Date Added:

September 5, 2018

Journal/Publication:

Healthy Hearts for Oklahoma

Publisher:

Agency for Healthcare Research and Quality

Type:

Clinical Decision Aids

Keywords

cardiovascular disease

MeSH

disease, cardiovascular

Effects of Aspirin on Risks of Vascular Events and Cancer According to Bodyweight and Dose: Analysis of Individual Patient Data from Randomised Trials

This is the decision aid for low-dose aspirin use developed for the Healthy Hearts for OK Project. For that project, we emphasized secondary prevention. Primary prevention is still controversial and situation-dependent.

The benefit of aspirin is not dose-dependent; use low-dose aspirin (81 mg) when indicated.

Effects of Aspirin on Risks of Vascular Events and Cancer According to Bodyweight and Dose: Analysis of Individual Patient Data from Randomised Trials

Jeffrey Wilson — Tue, 28 Aug 2018 19:33:50 +0000

Date Added:

September 26, 2018

Journal/Publication:

Lancet

Publisher:

Elsevier

Publication Date:

August 4, 2018

Issue:

10145

Volume:

392

Pages:

387-399

URL:

Type:

Meta-analyses, Reviews, and Guidelines, Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/S0140-6736(18)31133-4

Keywords

cancer

PMID (1):

30017552

MeSH

disease, cardiovascular