Enhancing bleeding reporting in acute coronary syndrome clinical trials: a systematic review of the ABC guidelines
Mariano García-Campa1,2,3, Samantha Medrano-Juarez2,3, Patricia Lizeth Castillo-Morales2,3
1Cardiology Service; "Dr. José E. González" University Hospital, Autonomous University of Nuevo León, Av. Francisco Madero s/n, 66640, Monterrey, México.
Insights
Few studies fully follow the Academic Bleeding Consensus (ABC) guidelines for reporting bleeding events in acute coronary syndromes (ACS). Inconsistent bleeding definition reporting hinders interpretation of ACS interventions and patient-centered decision-making.
Area of Science:
- Cardiology
- Clinical Research Methodology
- Evidence-Based Medicine
Background:
- Bleeding events in acute coronary syndromes (ACS) significantly impact patient outcomes.
- Consistent reporting of bleeding is a challenge for clinicians.
- The Academic Bleeding Consensus (ABC) provides the only dedicated reporting guideline for bleeding events.
Purpose of the Study:
- To evaluate the adoption of the ABC guidelines in clinical research.
- To assess adherence to bleeding definition reporting in randomized clinical trials (RCTs) for ACS.
Main Methods:
- Systematic search of Scopus, Web of Science, MEDLINE, EMBASE, and Cochrane Central.
- Included RCTs involving adult patients with ACS, published between 2012 and 2025.
- Quantitative analysis of 135 RCTs for adherence to ABC guidelines and bleeding definition reporting.
Main Results:
- None of the 135 included RCTs fully adhered to the ABC reporting guidelines.
- The Bleeding Academic Research Consortium (BARC) definition was most used (73.3%) but often incompletely reported (82.8%).
- Industry funding, focus on patient-important outcomes, and explicit bleeding outcome reporting correlated with better adherence.
Conclusions:
- Lack of adherence to ABC guidelines necessitates a universal reporting framework.
- An integrated framework for qualitative and quantitative bleeding characteristics is needed.
- Improved reporting will enhance interpretability of ACS interventions and support patient-centered decisions.
Background:
Bleeding events in acute coronary syndromes (ACS) significantly affect patient outcomes, yet consistent reporting remains a challenge for clinicians. Although multiple standardized bleeding definitions exist, the Academic Bleeding Consensus (ABC) provides the only dedicated reporting guideline. This systematic review evaluates the adoption of the ABC guidelines and adherence to bleeding definition reporting in clinical research.
Methods:
We systematically searched Scopus, Web of Science, MEDLINE, EMBASE, and Cochrane Central for randomized clinical trials (RCTs) published between 2012 and 2025 involving adult patients with ACS.
Results:
Of the 135 RCTs included in the quantitative analysis, none fully adhered to the ABC reporting guidelines. Most trials only partially reported elements in the red and green domains, with only two RCTs fully reporting the orange domain. The Bleeding Academic Research Consortium (BARC) definition was the most frequently used (73.3%), though its reporting was often incomplete (82.8%). Industry-funded RCTs (OR: 3.66; 95%CI: 1.55-2.90), those prioritizing patient-important outcomes (OR: 13.22; 95%CI: 1.72-101.27), and trials with bleeding outcome reporting according to definition (OR: 3.88; 95%CI 10.22) were more likely to fully report bleeding definitions. Conversely, RCTs using the BARC definition showed lower rates of complete reporting.
Conclusion:
The lack of adherence to the ABC guidelines highlights the need for a universally accepted reporting framework that integrates qualitative and quantitative bleeding characteristics. Such a guideline would enhance the interpretability of ACS interventions, supporting better patient-centered decision-making.
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