Risk of major bleeding in patients receiving vitamin K antagonists or low doses of aspirin. A systematic review and meta-analysis

source extracted confidence: high 2026-04-09
#anticoagulants #aspirin #fibrinolytic-agents #hemorrhage #humans

Risk of major bleeding in patients receiving vitamin K antagonists or low doses of aspirin. A systematic review and meta-analysis

Vazquez et al., 2016 | Thromb Res | Meta Analysis

Citation

Vazquez Fernando J, Gonzalez Joaquín P, ... Gándara Esteban. Risk of major bleeding in patients receiving vitamin K antagonists or low doses of aspirin. A systematic review and meta-analysis. Thromb Res. 2016-Feb;138:1-6. doi:10.1016/j.thromres.2015.12.013

Abstract

UNLABELLED: Prior meta-analysis and observational studies have suggested that the bleeding risks associated with anticoagulation using vitamin K antagonists (VKA) or aspirin (ASA) are similar. OBJECTIVE: The aim of this systematic review was to provide the odds ratios (ORs) of major bleeding, intracranial bleeding or major extra-cranial bleeding of anticoagulation with VKA compared to low doses of ASA. METHODS: We conducted a systematic review of Ovid MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (RCT). Randomized controlled trials reporting bleeding rates in adult patients randomized to a VKA (INR 2-3) or to ASA alone (<325mg daily). Random effects OR were calculated. RESULTS: Fifteen trials reporting the outcome of 2511 participants treated with VKA alone and 2471 treated with ASA alone were included; most common conditions evaluated were non-valvular atrial fibrillation (five trials) and heart failure (three trials). Overall, the use of VKA was associated with an increased risk of major bleeding (OR 1.76 (95% CI 1.33-2.33) when compared to ASA. The OR associated with VKA use for intracranial bleeding and extra-cranial bleeding were 1.74 (95% CI 0.83-3.62) and 1.66 (95% CI 0.94-2.92), respectively. In trials achieving good control of anticoagulation [time in therapeutic range (TTR) >65%], the risk of bleeding with VKA was similar to that of ASA [OR 1.16 (95% CI 0.79-1.71)]. CONCLUSION: Contrary to prior reports our results suggest that the risk of major bleeding with the use VKA is higher compared to those of patients treated with ASA alone. However, in patients achieving a good TTR, the risk of major bleeding with VKA or ASA is similar.

Key Findings

Fifteen trials reporting the outcome of 2511 participants treated with VKA alone and 2471 treated with ASA alone were included; most common conditions evaluated were non-valvular atrial fibrillation (five trials) and heart failure (three trials). Overall, the use of VKA was associated with an increased risk of major bleeding (OR 1.76 (95% CI 1.33-2.33) when compared to ASA. The OR associated with VKA use for intracranial bleeding and extra-cranial bleeding were 1.74 (95% CI 0.83-3.62) and 1.66 (

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population adult patients
Sample Size 2511
Age Range See abstract
Condition See abstract

MeSH Terms

  • Anticoagulants
  • Aspirin
  • Fibrinolytic Agents
  • Hemorrhage
  • Humans
  • Intracranial Hemorrhages
  • Odds Ratio
  • Risk Assessment
  • Vitamin K

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Systematic Review
  • Vertical: vitamin-k

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09