Download Online Table 1. Key elements of the bleeding classifications used in

Online Table 1. Key elements of the bleeding classifications used in this analysis
BARC bleeding definition1
Type 0
No bleeding
Type 1
Bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies,
hospitalization, or treatment by a health care professional; may include episodes leading to selfdiscontinuation of medical therapy by the patient without consulting a health care professional
Type 2
Any overt, actionable sign of hemorrhage (e.g., more bleeding than would be expected for a clinical
circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5
but does meet at least one of the following criteria:
(1) Requiring nonsurgical, medical intervention by a health care professional
(2) Leading to hospitalization or increased level of care
(3) Prompting evaluation
Type 3
Type 3a

Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to
bleed)

Any transfusion with overt bleeding
Type 3b

Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed)

Cardiac tamponade

Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid)

Bleeding requiring intravenous vasoactive agents
Type 3c

Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does
include intraspinal)

Subcategories confirmed by autopsy or imaging or lumbar puncture

Intraocular bleed compromising vision
Type 4

Perioperative intracranial bleeding within 48 hours

Reoperation after closure of sternotomy for the purpose of controlling bleeding

Transfusion of ≥5 U whole blood or packed red blood cells within a 48-hour period (only
allogenic transfusions are considered transfusions for CABG-related bleeds)

Chest tube output ≥2 L within a 24-hour period
Notes: If a CABG-related bleed is not adjudicated as at least a type-3 severity event, it will be classified as
not a bleeding event. If a bleeding event occurs with a clear temporal relationship to CABG (i.e., within a
48-hour time frame) but does not meet type-4 severity criteria, it will be classified as not a bleeding event.
Type 5
Type 5a

Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious
Type 5b

Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
TIMI bleeding definition2*
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 but <5 g/dL decrease in the hemoglobin concentration or ≥10% but
<15% decrease in the hematocrit

No observed blood loss: ≥4 g/dL decrease in the hemoglobin concentration or ≥12% decrease in
the hematocrit
Requiring

for a major or minor bleeding event, as defined above
medical
attention
Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria

Requiring intervention (medical practitioner-guided medical or surgical treatment to stop or treat
bleeding, including temporarily or permanently discontinuing or changing the dose of a
medication or study drug)

Leading to or prolonging hospitalization

Prompting evaluation (leading to an unscheduled visit to a health care professional and
diagnostic testing, either laboratory or imaging)
GUSTO bleeding definition
Severe or lifethreatening
Moderate
Mild

Intracranial hemorrhage

A bleeding event that causes hemodynamic compromise and requires intervention

A bleeding event that requires blood transfusion but does not result in hemodynamic compromise

Bleeding that does not meet above criteria
*All BARC and TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are
adjusted by 1 g/dL or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or
hematocrit if there has been an intervening transfusion between 2 blood measurements is calculated as follows: Δ
Hemoglobin (Hgb) = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; ΔHematocrit (Hct) = [baseline
Hct - post-transfusion Hct] + [number of transfused units x 3].
BARC: Bleeding Academic Research Consortium, GUSTO: Global Strategies for Opening Occluded Coronary Arteries;
TIMI: Thrombolysis In Myocardial Infarction.
Online Table 2. Algorithm used to derive BARC categories from data adjudicated by the Clinical Events Committee 1-3
Original CEC classification
Key data elements
Corresponding
BARC grade
No bleeding occurred
No evidence of bleeding
Type 0
Bleeding not qualifying as any TIMI
Bleeding that is not actionable and does not cause the patient to seek unscheduled performance of
Type 1
bleeding but qualifying as GUSTO mild
studies, hospitalization, or treatment by a health care professional
bleeding
TIMI bleeding requiring medical attention
Any overt, actionable sign of hemorrhage* that does not fit the criteria for type 3, 4, or 5 but does meet
and GUSTO mild bleeding
at least one of the following criteria:
TIMI minor or GUSTO moderate

Requiring nonsurgical, medical intervention by a health care professional

Leading to hospitalization or increased level of care

Prompting evaluation

Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to
bleeding
bleed)

Any transfusion with overt bleeding
Type 2
Type 3a
Original CEC classification
Key data elements
Corresponding
BARC grade
Non-CABG, non-fatal, non-ICH bleeding
that satisfies of any of the following:

TIMI major

GUSTO severe


Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed)

Cardiac tamponade

Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid)

Bleeding requiring intravenous vasoactive agents

Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does
Type 3b
Reported pericardial
bleeding and GUSTO severe
(excluding CABG-related)
bleeding
Intracranial bleeding excluding ischemic
stroke with hemorrhagic transformation
TIMI major CABG related bleeding
Fatal bleeding
Type 3c
include intraspinal)

Subcategories confirmed by autopsy or imaging or lumbar puncture

Intraocular bleed

Perioperative intracranial bleeding within 48 hours

Reoperation after closure of sternotomy for the purpose of controlling bleeding

Transfusion of ≥5 U whole blood or packed red blood cells within a 48-hour period

Chest tube output ≥2 L within a 24-hour period compromising vision

Probable or definite fatal bleeding
*E.g., more bleeding than would be expected for a clinical circumstance, including bleeding.
Type 4
Type 5
BARC: Bleeding Academic Research Consortium, GUSTO: Global Strategies for Opening Occluded Coronary Arteries; TIMI: Thrombolysis In Myocardial
Infarction;
non-ICH;
non-intracranial
hemorrhage.
Online Table 3. Mortality rates among subjects with BARC 3a, 3b, 3c, and 4 bleeding classes with or without transfusion
BARC class
Bleed
Kaplan-Meier estimated death rate
Death at 30 days post bleeding
Death at 1 year post bleeding
Death at 2 years post bleeding
3.5% (0.8%, 6.2%)
10.1% (5.3%, 14.9%)
12.4% (6.8%, 18%)
5.4% (1.9%, 8.9%)
18.5% (12.1%, 24.9%)
28.2% (19.3%, 37.1%)
12.8% (5.7%, 19.9%)
17.2% (8.8%, 25.6%)
20.2% (7.1%, 33.3%)
11.3% (6.4%, 16.2%)
23.5% (16.7%, 30.3%)
25.1% (17.8%, 32.4%)
33.9% (22.4%, 45.4%)
47.5% (33.8%, 61.2%)
47.5% (33.8%, 61.2%)
33.3% (-20%, 86.6%)
—
—
9.5% (-3.1%, 22.1%)
9.5% (-3.1%, 22.1%)
9.5% (-3.1%, 22.1%)
Class 3a
Without transfusion
168/344 (48.8%)
With transfusion
176/344 (51.2%)
Class 3b
Without transfusion
86/250 (34.4%)
With transfusion
164/250 (65.6%)
Class 3c
Without transfusion
With transfusion
65/68 (95.6%)
3/68 (4.4%)
Class 4
Without transfusion
21/155 (13.6%)
With transfusion
134/155 (86.4%)
8.2% (3.5%, 12.9%)
15.2% (9.1%, 21.3%)
15.2% (9.1%, 21.3%)
BARC: Bleeding Academic Research Consortium, GUSTO: Global Strategies for Opening Occluded Coronary Arteries; TIMI: Thrombolysis In Myocardial
Infarction.
Online Figure 1. Cumulative incidences of bleeding according to BARC criteria
BARC: Bleeding Academic Research Consortium, GUSTO: Global Strategies for Opening Occluded Coronary Arteries; TIMI: Thrombolysis In Myocardial
Infarction.
Online Figure 2. Cumulative mortality following a BARC 2, 3, or 4 bleed during index stay and at different landmarks post discharge
BARC: Bleeding Academic Research Consortium
Online References
1. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular
clinical trials: a consensus report from the Bleeding Academic Research Consortium.
Circulation. 2011;123(23):2736-47.
2. Anderson JL, Adams CD, Antman EM, et al. 2011 ACCF/AHA Focused Update
Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients with
Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American
College of Cardiology Foundation/American Heart Association Task Force on Practice
Guidelines. Circulation. 2011;123(18):e426-579.
3. Bassand JP, Hamm CW, Ardissino D, et al. Guidelines for the diagnosis and treatment of
non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007;28(13):1598660.