Bleeding Risks With Non-Vitamin K Oral Anticoagulants Versus Single Antiplatelet Therapy : A Systematic Review and Meta-analysis of Randomized Trials

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#humans #hemorrhage #anticoagulants #randomized-controlled-trials-as-topic #platelet-aggregation-inhibitors

Bleeding Risks With Non-Vitamin K Oral Anticoagulants Versus Single Antiplatelet Therapy : A Systematic Review and Meta-analysis of Randomized Trials

Wang et al., 2025 | Ann Intern Med | Meta Analysis

Citation

Wang Michael Ke, Baskaran Geethan, ... Conen David. Bleeding Risks With Non-Vitamin K Oral Anticoagulants Versus Single Antiplatelet Therapy : A Systematic Review and Meta-analysis of Randomized Trials. Ann Intern Med. 2025-Mar;178(3):360-368. doi:10.7326/ANNALS-24-02132

Abstract

BACKGROUND: In several settings, therapeutic-dose non-vitamin K oral anticoagulants (NOACs) are superior to aspirin for the prevention of arterial and venous thromboembolism. PURPOSE: To estimate differences in bleeding risks between NOACs and single antiplatelet therapy. DATA SOURCES: MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from inception to June 2024 without language restrictions. STUDY SELECTION: Randomized controlled trials (RCTs) comparing therapeutic-dose NOACs versus single antiplatelet therapy, with a minimum treatment duration of 3 months. DATA EXTRACTION: Data extraction was done independently and in duplicate. DATA SYNTHESIS: Nine RCTs with 26 224 participants were included. All studies used aspirin as antiplatelet therapy. Compared with aspirin, apixaban had similar rates of major bleeding (risk difference [RD], 0.0 percentage point [95% CI, -1.3 to 2.6 percentage points]; 5 trials) and intracranial hemorrhage (RD, -0.2 percentage point [CI, -0.6 to 1.4 percentage points]; 5 trials). Compared with aspirin, dabigatran had similar rates of major bleeding (RD, 0.5 percentage point [CI, -2.1 to 19.6 percentage points]; 2 trials) and intracranial hemorrhage (RD, 0.0 percentage point [CI, -1.1 to 24.5 percentage points]; 2 trials). Compared with aspirin, rivaroxaban had higher rates of major bleeding (RD, 0.9 percentage point [CI, -0.1 to 3.7 percentage points]; 2 trials) and intracranial hemorrhage (RD, 0.3 percentage point [CI, -0.1 to 79.7 percentage points]; 2 trials). The evidence certainty ranged from low to moderate. LIMITATION: Confidence intervals were wide and included the possibility of a null effect. CONCLUSION: In this systematic review of RCTs, rates of major bleeding for therapeutic-dose apixaban and dabigatran were similar to those for low-dose aspirin, whereas rates were higher for rivaroxaban. PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42024553683).

Key Findings

In this systematic review of RCTs, rates of major bleeding for therapeutic-dose apixaban and dabigatran were similar to those for low-dose aspirin, whereas rates were higher for rivaroxaban. PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42024553683).

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 224
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Hemorrhage
  • Anticoagulants
  • Randomized Controlled Trials as Topic
  • Platelet Aggregation Inhibitors
  • Aspirin
  • Administration, Oral
  • Pyrazoles
  • Pyridones

Evidence Classification

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

Provenance

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