Unstable angina non ST elevation myocardial infarction complications of bleeding and transfusion - definitions for bleeding complications
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Unstable angina non ST elevation myocardial infarction complications of bleeding and transfusion - definitions for bleeding complications On the Web |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Template:MWT; Cafer Zorkun, M.D., Ph.D. [2]; Varun Kumar, M.B.B.S.; Lakshmi Gopalakrishnan, M.B.B.S.
Overview
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][2][3] 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. 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,[4] PURSUIT[5] and OASIS-5[6] trials or have adopted trial specific definitions for bleeding complications such as those in FRISC[7], ESSENCE[8], CURE[9] and ACUITY[10] 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.
References
- ↑ Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P. Thrombolysis In Myocardial Infarction (TIMI) trial, phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987; 76:142–154.
- ↑ Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE II, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 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/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction). Circulation 2007 116: e148 – e304. PMID 17679616
- ↑ Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE II, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. Correction of 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/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction). J Am Coll Cardiol. 2008 Mar 4; 51(9): 974. PMID 17692738
- ↑ Ferguson JJ, Califf RM, Antman EM, Cohen M, Grines CL, Goodman S, Kereiakes DJ, Langer A, Mahaffey KW, Nessel CC, Armstrong PW, Avezum A, Aylward P, Becker RC, Biasucci L, Borzak S, Col J, Frey MJ, Fry E, Gulba DC, Guneri S, Gurfinkel E, Harrington R, Hochman JS, Kleiman NS, Leon MB, Lopez-Sendon JL, Pepine CJ, Ruzyllo W, Steinhubl SR, Teirstein PS, Toro-Figueroa L, White H; SYNERGY Trial Investigators. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA. 2004;292:45-54.
- ↑ The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. The PURSUIT Trial Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy. N Engl J Med. 1998;339:436–43.
- ↑ Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354:1464-76.
- ↑ Fragmin and Fast Revascularization during Instability in Coronary artery disease Investigators, Long-term low-molecular-mass heparin in unstable coronary artery disease: FRISC II prospective randomized multicentre study. Lancet 1999;354:701–707.
- ↑ Cohen M, Demers C, Gurfinkel EP, Turpie AG, Fromell GJ, Goodman S, Langer A, Califf RM, Fox KA, Premmereur J, Bigonzi F. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med. 1997;337:447-52.
- ↑ Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001;345:494 –502.
- ↑ Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM; ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203-16.