Validation of the Bleeding Academic Research Consortium Definition of Bleeding in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
What is the long-term implication of the Bleeding Academic Research Consortium (BARC) unified definition of bleeding in patients undergoing percutaneous coronary intervention (PCI)?
The authors evaluated the relationship between bleeding events, as defined by BARC, and 1-year mortality in patients undergoing PCI in a patient-level pooled analysis of 12,459 patients recruited in six randomized trials of patients undergoing PCI. They also assessed whether the BARC bleeding definition is superior to Thrombolysis in Myocardial Infarction (TIMI) and Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial criteria regarding mortality prediction in patients after PCI procedures.
Any BARC bleeding occurred in 1,233 patients (9.9%), whereas BARC class >2 bleeding was seen in 679 patients (5.4%), TIMI major or minor bleeding in 374 patients (3.0%), and REPLACE-2 major bleeding in 491 (3.9%) patients. There were 340 deaths (2.7%) over the first year following PCI. A BARC class >2 bleeding was associated with a significant increase in the 1-year mortality (adjusted hazard ratio, 2.72; 95% confidence interval, 2.03-3.63). All of the three definitions provided a similar increase in the predictivity of a multivariable model for 1-year mortality.
The authors concluded that there was a close association between bleeding events defined according to BARC and 1-year mortality after PCI.
The BARC criteria have been recently proposed as a measure to standardize bleeding definitions across clinical studies. This study suggests that BARC criteria are more sensitive, but less specific at predicting 1-year mortality, but overall, they performed as well as the TIMI or REPLACE-2 definitions. Since BARC follows a hierarchical bleeding category that is clinically intuitive, and appears to have a diagnostic accuracy similar to the other commonly followed definitions, it definitely merits consideration as the reference standard for future studies.
Keywords: Coronary Artery Disease, Myocardial Infarction, Recombinant Proteins, Peptide Fragments, Coronary Disease, Confidence Intervals, Hirudins, Percutaneous Coronary Intervention
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