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. 2009 Jun;4(6):1032–1043. doi: 10.2215/CJN.05551008

Table 1.

Study design of included trialsa

Parameter Trial Name
VINO FRISC II TIMI IIIB TACTICS-TIMI 18 ICTUS
Year 2002 2001 1994 2001 2005
Interventions First-day angiography versussymptom/stress test–driven angiography First-week angiography versussymptom/stress test–driven angiography Dalteparin versusplacebo Angiography within 18 to 48 h versussymptom/stress test–driven angiography TPA versusplacebo Angiography within 4 to 48 h versussymptom/stress test–driven angiography Angiography within 24 to 48 h versussymptom/stress test–driven angiography
Type of ACS Non-STEMI Non-STEMI and UA Non-Q wave MI and UA Non-STEMI and UA Non-STEMI
Major exclusions Cardiogenic shock, Q-wave MI, thrombolysis within 30 d, disease with effect on 1-yr prognosis Age >75, previous CABG, waiting list for revascularization, thrombolysis or PTCA within 6 mo, renal or hepatic insufficiency, severe illness Treatable cause of ischemia, MI within 21 d, angiography within 30 d, PTCA within 6 mo, previous CABG, pulmonary edema, uncontrolled hypertension, contraindication to anticoagulation, severe illness ST elevation, CABG or PTCA within 6 mo, severe CHF, severe shock, serious systemic disease Age >80, STEMI within 48 h, indication for primary PTCA or thrombolysis, pulmonary edema, hemodynamic instability, fibrinolytics within 96 h, PTCA within 14 d
Renal exclusion NA >1.8 mg/dl >3 mg/dl Creatinine >2.5 mg/dl NA
Primary end point Composite of death and nonfatal MI Composite of death and MI Composite of death, MI, or “unsatisfactory” stress test Composite of death, MI, and rehospitalization for acute coronary syndrome Composite of death, MI, or hospitalization for angina
Interval for assessment of primary end point 6 mo 6 mo 6 wk 6 mo 1 yr
GIIb/IIIa inhibitors None Abciximab None Tirofiban Abciximab
Anticoagulants UFH UFH, Dalteparin UFH UFH Enoxaparin
Procedural MI Not diagnosed within 72 h At least two of the following: (1) CK-MB >1.5× ULN in one sample or CK, CK-B, or CK-MB activity >1.5× ULN in two samples or CK, CK-B, or CK-MB activity >3× ULN in one sample; (2) chest pain; or (3) diagnostic ECG changes Post-CABG: CK or CK-MB >5× ULN; otherwise, CK-MB>ULN or CK >2× ULN CK-MB >3× ULN and if preprocedure CK elevated a ≥50% over preprocedure and documentation that decreasing before procedure or new Q waves and/or pathologic findings distinct from index MI Within first 48 h in patients with elevated CK-MB at randomization: CK-MB >ULN after a 50% decrease from peak value; otherwise, CK-MB >ULN. Post-CABG: New Q waves
Nonprocedural MI Ischemic ECG changes with CK-MB >1.5× ULN or positive troponin I At least two of the following: (1) CK-MB >ULN in one sample or CK, CK-B, or CK-MB activity >ULN in two samples; (2) chest pain; or (3) diagnostic ECG changes CK-MB> ULN OR CK >2× ULN (1) New Q waves distinct from index MI or both (b) Troponin >ULN or CK-MB >ULN or CK >2× ULN and ST/T wave changes or ischemic chest pain; or (3) pathologic findings of acute MI CK-MB >ULN
Intention-to-treat analysis Yes Yes Yes Yes Yes
Loss to follow-up (%) 0 <5 <5 <5 <1
Outcomes blinded? Yes Yes Yes Yes Yes
a

ACS, acute coronary syndrome; CABG, coronary artery bypass grafting; CHF, congestive heart failure; CK, creatinine kinase; ECG, electrocardiogram; GIIb/IIIa, glycoprotein IIb/IIIa; MI, myocardial infarction; NA, not applicable; PTCA, percutaneous transluminal coronary angioplasty; STEMI, ST elevation MI; TIMI IIIB, Thrombolysis in Myocardial Infarction IIIB; TPA, tissue plasminogen activator; UA, unstable angina; UFH, unfractionated heparin; ULN, upper limit of normal; TIMI IIIB, Thrombolysis in Myocardial Infarction IIIb Trial; VINO, Value of first day angiography/angioplasty in evolving non-ST segment elevation myocardial infarction: An open multicenter randomized trial; FRISC II, FRagmin and Fast Revascularisation during InStability in Coronary artery disease II trial; ICTUS, Invasive versus Conservative Treatment in Unstable Coronary Syndromes; TACTICS-TIMI 18, Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy—Thrombolysis in Myocardial Infarction 18 Trial.