Aspirin Efficacy in Primary Prevention: A Meta-analysis of Randomized Controlled Trials

  • Mahmoud BarbarawiEmail author
  • Babikir Kheiri
  • Yazan Zayed
  • Inderdeep Gakhal
  • Ahmad Al-Abdouh
  • Owais Barbarawi
  • Laith Rashdan
  • Fatima Rizk
  • Ghassan Bachuwa
  • Mohammad Luay Alkotob
Review article



The role of aspirin as a means of primary prevention remains controversial.


We have conducted a meta-analysis of all randomized controlled trials (RCTs) to evaluate the role of aspirin in primary prevention.


Literature search was performed via PubMed, Embase, and the Cochrane Library for all related RCTs. All-cause mortality was the primary endpoint. Secondary endpoints included major adverse cardiovascular events (MACE), myocardial infarction (MI), cardiovascular mortality, cerebrovascular events, and bleeding events. We used a random effects model to report the risk ratios (RRs) with 95% confidence intervals (CIs).


Our analysis included 17 RCTs (164,862 patients; 83,309 received aspirin and 81,744 received placebo). Our study did not demonstrate any significant reduction in all-cause mortality for patients treated with aspirin when compared with placebo (RR 0.97; 95% CI 0.93–1.01; P = 0.13). Sensitivity analysis performed by excluding healthy elderly (≥ 65) showed significant reductions in all-cause mortality in the aspirin-treated patients (RR 0.94; 95% CI 0.90–0.99; P = 0.01). There were no significant differences between both groups regarding cardiovascular mortality and cerebrovascular events (P > 0.05). However, aspirin-treated patients significantly reduced MACE and MI events (RR 0.89; 95% CI 0.85–0.93; P < 0.001 and RR 0.88; 95% CI 0.78–0.98; P = 0.02, respectively), respectively. However, aspirin was associated with a significantly higher incidence of bleeding, including major bleeding and intracranial bleeding (P < 0.001).


Aspirin use in primary prevention has resulted in a lower incidence of MACE and MI without significantly effecting cerebrovascular events. However, aspirin was associated with a higher bleeding risk. Use of aspirin as a means of primary prevention should be thoroughly discussed with patients and pursued based on the risk of cardiovascular disease while also considering bleeding risk.


Aspirin Primary prevention Meta-analysis Cardiovascular disease 


Author Contributions

MB: study design, data extraction, data analysis, manuscript drafting, and final approval; BK: study design, data extraction, data analysis, manuscript drafting, and final approval; YZ: data search, data extraction, analysis, and final approval; IG: data search, data extraction, and final approval; AA: data extraction, data analysis, and final approval; OB: study design, manuscript drafting, and final approval; LR: data analysis, figure creation, and final approval; GB: data interpretation, manuscript revising, and final approval; MLA: data interpretation, manuscript revising, and final approval.

Compliance with Ethical Standards

Conflict of interest

The authors report no relationships that could be construed as a conflict of interest.



Ethical approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Supplementary material

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Copyright information

© Italian Society of Hypertension 2019

Authors and Affiliations

  • Mahmoud Barbarawi
    • 1
    Email author
  • Babikir Kheiri
    • 1
  • Yazan Zayed
    • 1
  • Inderdeep Gakhal
    • 1
  • Ahmad Al-Abdouh
    • 2
  • Owais Barbarawi
    • 3
  • Laith Rashdan
    • 1
  • Fatima Rizk
    • 4
  • Ghassan Bachuwa
    • 1
  • Mohammad Luay Alkotob
    • 5
  1. 1.Department of Internal MedicineHurley Medical Center/Michigan State UniversityFlintUSA
  2. 2.Department of Internal MedicineSaint Agnes HospitalBaltimoreUSA
  3. 3.Department of Internal medicineMutah UniversityAl-KarakJordan
  4. 4.College of Osteopathic MedicineMichigan State UniversityEast LansingUSA
  5. 5.Division of CardiologyHurley Medical Center/Michigan State UniversityFlintUSA

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