Unstable angina / non ST elevation myocardial infarction complications of bleeding and transfusion - definitions for bleeding complications


 * ; ; Varun Kumar, M.B.B.S.; Lakshmi Gopalakrishnan, M.B.B.S.

Definitions for bleeding complications

 * The two most commonly employed bleeding severity classification schemes are the Thrombolysis In Myocardial Infarction (TIMI) and the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scales.
 * 1) The GUSTO scale categorizes bleeding as severe or life-threatening, moderate, mild, or none and defines bleeding based on clinical outcomes such as hemodynamic compromise or intracranial hemorrhage.
 * 2) The TIMI definition categorizes bleeding as major, minor, minimal, or none and is dependent on changes in laboratory parameters (hemoglobin or hematocrit) and not necessarily on clinically defined events (although intracranial hemorrhage is considered a TIMI major bleed).


 * Additional definitions of bleeding events adopt variations of the GUSTO and TIMI classification schemes such as those developed in the SYNERGY, PURSUIT and OASIS-5 trials or have adopted trial specific definitions for bleeding complications such as those in FRISC, ESSENCE , CURE and ACUITY trials.

GUSTO scale

 * Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention
 * Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise
 * Mild: Bleeding that does not meet criteria for either severe or moderate bleeding

TIMI scale

 * Major: Intracranial hemorrhage or a 5 g/dl decrease in the hemoglobin concentration or a  15% absolute decrease in the hematocrit.
 * Minor:
 * Observed blood loss: 3 g/dl decrease in the hemoglobin concentration or 10% decrease in the hematocrit
 * No observed blood loss: 4 g/dl decrease in the hemoglobin concentration or 12% decrease in the hematocrit


 * Minimal: Any clinically overt sign of hemorrhage (including imaging) that is associated with a <3 g/dl decrease in the hemoglobin concentration or <9% decrease in the hematocrit

OASIS-2 trial

 * Major bleeding:
 * Life-threatening (fatal, intracranial, requiring surgical intervention or 4 units of blood or plasma expanders)
 * Other major bleeding episodes (any event requiring transfusion of 2 or 3 units or judged to be disabling).


 * Minor Bleeding: All other bleeding events.

OASIS-5 trial

 * Major Bleeding:
 * Fatal, intracranial, retroperitoneal, intraocular leading to vision loss.
 * Decrease in Hgb 3 g/dL adjusted for transfusion.
 * Transfusion of 2 units.


 * Minor Bleeding: Any other clinically significant bleeding not meeting Major criteria leading to study drug interruption, surgery, or transfusion of 1 unit of blood.

CURE trial

 * Major bleeding:
 * Life-threatening (fatal, intracranial, requiring surgical intervention, results in hypotension, decrease in Hgb 5 g/dL, or required  4 units of blood).
 * Other major bleeding episodes (requiring transfusion of 2 or 3 units, intraocular).


 * Minor bleeding: Led to discontinuation of study drug

ACUITY trial

 * Major Bleeding:
 * Intracranial or intraocular bleeding.
 * Hemorrhage at the access site requiring intervention or hematoma with a diameter of at least 5 cm.
 * Hemoglobin decrease of at least 4 g per deciliter without an overt bleeding source or at least 3 g per deciliter with such a source.
 * Reoperation for bleeding.
 * Transfusion of a blood product.


 * Minor Bleeding: not defined

The existence of multiple trial-specific definitions of bleeding events, in addition to TIMI and GUSTO precludes the ability to compare bleeding complication rates across NSTEMI. The variability of pharmacological therapies employed in NSTEMI trials further confounds the ability to clearly define and to determine a single estimate of the incidence of bleeding complications among NTEMI patients.