VINO.
Methods | Prospective, randomised, multicentre trial with parallel groups. | |
Participants | 131 participants with ischaemic chest pain lasting more than 20 mins (within the preceding 24 hours) and ECG changes and elevated cardiac markers Overall impression on level of risk in participants: high; all participants were cardiac biomarker positive | |
Interventions | Conservative arm: aspirin, beta blocker, UFH Invasive arm: as above and routine angiography (average time to angiography: 6.2 hours). 0% glycoprotein 2b/3a receptor antagonist use | |
Outcomes | Death all causes (30 days, 6 months), MI (30 days, 6 months), death or non‐fatal MI (30 days, 6 months), rehospitalisation (30 days, 6 months) | |
Notes | Recruitment commenced May 1998. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequentially numbered envelopes. |
Allocation concealment (selection bias) | Low risk | Sealed envelope. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were accounted for by the end of the trial; the trial used ITT analysis. |
Other bias | Low risk | We did not detect any other sources of bias. |
ACEI = angiotensin converting enzyme inhibitors; UFH = unfractionated heparin; MI = myocardial infarction; ITT = intention to treat; ECG = electrocardiogram; UA = unstable angina; STEMI = ST segment elevation myocardial infarction; CAD = coronary artery disease