Italian Elderly ACS.
Methods | Prospective, randomised, multicentre trial | |
Participants | 313 participants with symptoms suggestive of acute myocardial ischaemia at rest within 48 hours before randomisation and ischaemic ECG changes (transient or persistent ST‐segment elevation or depression > 0.5 mm but < 1 mm in the case of ST‐elevation or persistent and definite T wave inversion > 1 mm in at least 2 contiguous leads) and/or elevate levels (> upper limit of normal) of creatine kinase‐myocardial band (CK‐MB) or cTn. Overall impression of level of risk in participants: high risk; all participants were elderly (≥ 75 years of age). |
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Interventions | Early aggressive strategy (coronary angiography and, when indicated, revascularization within 72 hours) or initially conservative strategy (angiography and revascularization only for recurrent ischaemia). | |
Outcomes | All‐cause death (6 months, 1 year), MI (6 months, 1 year), rehospitalisation (6 month, 1 year), major bleeding (6 months, 1 year), days spent in hospital (6 months, 1 year), stroke (6 month, 1 year). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated list, stratified by the centre, and randomly balanced every 4, 6 or 8 participants for each centre. |
Allocation concealment (selection bias) | Low risk | Centralised randomisation was immediately made available to the investigator upon registering the participant on the website http://elderly.altavianet.it. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessments were collected in a web‐based case report form. This was audited/supervised by study monitors who visit study centres. An independent event adjudication committee adjudicated all serious adverse events on the basis of the review of the original source documents. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four participants were lost to follow‐up and 2 participants withdrew. Attrition was equal between groups. All recruited participants were accounted for in analysis of each group on an ITT basis. |
Other bias | Low risk | There was no industry sponsorship. |