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 |
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.