| Methods |
Prospective, randomised, multicentre trial. |
| Participants |
1200 participants with accelerating angina or angina at rest in the preceding 24 hours and an elevated cardiac troponin T > 0.3 µg/L and either ischaemic ECG changes or a documented history of coronary artery disease (CAD) (previous catheterization, history of myocardial infarction (MI) or positive exercise test).
Overall impression on level of risk in participants: high risk; all participants had a positive troponin test on randomisation. |
| Interventions |
Conservative arm: aspirin, enoxaparin, statin, clopidogrel.
Invasive arm: as above, abciximab and routine angiography (median time to angiography: 23 hours) postrandomisation. 94% glycoprotein 2b/3a receptor antagonist use. |
| Outcomes |
Death all causes (1, 3 and 4 years), MI (1 and 3 years), rehospitalisation (1 and 3 years), major bleeding during the index admission. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Permuted‐block randomisation, with stratification according to site, with block size randomly chosen to be 4, 6 or 8. Baseline characteristics were comparable between groups. |
| Allocation concealment (selection bias) |
Low risk |
Eligibility was confirmed prior to contacting a central telephone system for allocation. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Open. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Members of an independent clinical endpoints committee, who were blinded to treatment allocation of participants, adjudicated endpoints. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Six participants were lost to follow‐up. The trial used ITT analysis. |
| Other bias |
Unclear risk |
Clopidogrel was more common at discharge for early invasive (61%) versus selective invasive (49%) strategies. There was sponsorship from Eli Lilly, Sanofi‐Synthelabo, Aventis, Pfizer and Medtronic. Sponsors were reported to have had no involvement in the design of the study, data collection or analysis, or the writing of the manuscript. |
