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. 2016 May 26;2016(5):CD004815. doi: 10.1002/14651858.CD004815.pub4

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).
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.