Standardized Bleeding Definitions for Cardiovascular Clinical Trials

Abstract

A dvances in antithrombotic therapy, along with an early invasive strategy, have reduced the incidence of recurrent ischemic events and death in patients with acute coronary syndromes (ACS; unstable angina, non-ST-segment-elevation myocardial infarction [MI], and ST-segment-elevation MI). [1][2][3][4] However, the combination of multiple pharmacotherapies, including aspirin, platelet P2Y 12 inhibitors, heparin plus glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, and the increasing use of invasive procedures, has also been associated with an increased risk of bleeding.

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

“…according to the patient charts, available reports, and the full hematological report. After reevaluating the severity of the complications, all events were reclassified and adjudicated according to the bleeding definitions proposed by the Valve Academic Research Consortium (VARC‐213), the Bleeding Academic Research Consortium (BARC14), the Thrombolysis in Myocardial Infarction investigators (TIMI16), and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries investigators (GUSTO17). Both investigators (S.S. and G.G.S.)…”

“…Subsequent to the implementation of these first set of guidelines, recommendations were revisited and updated in view of initial experiences and to address the future needs of clinical trials culminating in the VARC‐2 consensus document 13. Similar to the previous version, VARC‐2 categorizes bleeding complications according to the severity in minor, major, and in life‐threatening type and acknowledges the previously established recommendation of the Bleeding Academic Research Consortium (BARC) 14. VARC‐2 endpoint definitions are based on expert consensus and have not been validated in a real‐world TAVI patient population to date.…”

More, More, More: Reducing Thrombosis in Acute Coronary Syndromes Beyond Dual Antiplatelet Therapy—Current Data and Future Directions

“…The definition of bleeding events has variably included laboratory parameters, such as decrease in hemoglobin, and clinical events, including the need for transfusion, surgery, cardiac tamponade, and hematoma. Standardization of bleeding reports using the BARC (Bleeding Academic Research Consortium) system would have been highly desirable but was not available at the time of some of these studies 33. Although it remains clear, regardless of the definitions used, that TT significantly increases the risk of bleeding compared with DAPT, the lack of uniformity in bleeding definition coupled with the lack of direct head‐to‐head comparisons of TT combinations makes it impossible to compare bleeding risk with different strategies.…”

Kyoto Congestive Heart Failure (KCHF) study: rationale and design

“…Clinical events such as in‐hospital death (all‐cause death, cardiac death, heart failure death, sudden death, and non‐cardiac death), arrhythmic events (malignant ventricular tachyarrhythmia, supraventricular tachyarrhythmia, appropriate or inappropriate implantable cardioverter defibrillator shock, and symptomatic bradyarrhythmia), stroke (cerebral infarction and haemorrhage), moderate to severe bleeding events (global use of strategies to open occluded coronary arteries bleeding definition; moderate to severe),15 adverse drug events (ADEs), acute coronary events, and infectious diseases during hospitalization will be evaluated. Cardiovascular interventions (surgical and catheter procedures) and device implantation during the index hospitalization will be regarded as clinical events.…”