《2011BARC心血管临床试验出血定义标准化专家共识》内容预览

Several definitions of bleeding have been used in published clinical trials and registries. Table 2 highlights the lack of uniformity in bleeding definitions among recent ACS and PCI clinical trials. Current bleeding definitions consist of both laboratory parameters, such as decreases in hemoglobin and hematocrit scores, and clinical events, including the need for transfusion or surgery, cardiac tamponade, hematomas, and various degrees of bleeding. Each definition incorporates a different combination of these data elements and then rank orders these combinations into severity categories, which vary widely between definitions.

The Thrombolysis in Myocardial Infarction (TIMI) bleed-ing criteria have been in use for nearly 30 years, and have been reported in most cardiovascular trials. These criteria were developed during the early TIMI trials to define and classify major and minor hemorrhagic events in patients with ST-segment– elevation MI treated with a fibrinolytic drug. The original TIMI definition relies predominantly on labora-tory data elements based on decreases in hemoglobin or hematocrit values after adjustment for the effect of blood transfusion.Over time, the definitions have evolved to represent a broader range of bleeding categories and events while specifically defining each individual category.

The current updated TIMI definition is shown in Table Potential limitations of the criteria include that they were developed in the fibrinolytic era, and thus typically charac-terized severe acute events and difficulties with perception of the nomenclature (eg, many would consider TIMI minor bleeding to hold greater clinical significance than that con-noted by the term minor). Common pitfalls that may occur when the TIMI definition is applied are recording hemoglo-bin drops without clinically overt signs as major bleeding events, as well as uncertainty on the timing of assessing hemoglobin values that may lead to inappropriate peaks and nadirs related to bleeding, therefore obscuring the timing of the bleeding in relation to the intervention. The TIMI criteria also characterize 3 different types of death in relation to bleeding: fatal bleeding, when a bleeding event directly leads to death within 7 days (eg, an intracranial hemorrhage that leads to herniation of the brain and death, hemopericardium that results in death, and a massive gastrointestinal hemor-rhage that results in shock, hemodynamic collapse, and death); bleeding contributing to death (ie, a death in which a bleeding event was part of a causal chain of medical events that ultimately led to death within 30 days of the bleed, but bleeding did not directly and/or immediately relate to sub-ject’s death; an example is a bleed resulting in discontinua-tion of antiplatelet therapy followed by stent thrombosis and death); and death unrelated to a bleeding event (the death was unrelated to bleeding because either there was no clinically significant bleeding in the month before death orthe bleeding event did not contribute to the subject’s death).

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