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. 2017 May 3;2017(5):CD011986. doi: 10.1002/14651858.CD011986.pub2

HELP AMI 2004.

Methods RCT multi‐centre.
Randomisation ratio: 3:1.
Number of study centres: not described in the article.
Participants Inclusion criteria: ischaemic chest pain started < 12 hours before hospital admission with or without ST‐segment elevation of ≥ 1 mm in ≥ 2 contiguous electrocardiographic leads (peripheral leads) or 2 mm in the precordial leads. MVD amenable to angioplasty of at least 2 lesions (culprit artery and ≥ 1 (maximum 3) lesions in a major non‐culprit coronary artery(ies)).
Exclusion criteria: presence of significant lesions in vein grafts or arterial conduits or in segments previously treated with angioplasty or stent, recent thrombolysis (< 1 week), cardiogenic shock, defined as hypotension with systolic blood pressure < 90 mmHg and tachycardia > 100 beats/minute, not due to hypovolaemia or requiring inotropic support or balloon counter pulsation. Single‐vessel disease, left main stenosis of ≥ 50%, intention to treat > 1 totally occluded major epicardial vessel, diffuse calcification or severe tortuosity in the culprit and non‐culprit arteries preventing the implantation of the study stents. A sided branch > 2 mm which required being covered by the stent, unless the operator was willing and technically able to maintain patency of this side branch with either further balloon angioplasty or stent placement.
Diagnostic criteria
MVD: not defined in the article.
Significant stenosis: not defined in the article.
Sample size: complete revascularisation n = 53 and culprit‐only revascularisation n = 17.
Interventions Complete revascularisation: PCI of all, culprit and non‐culprit coronary artery lesions suitable to intervention with a heparin‐coated stent.
Culprit‐only revascularisation: PCI of culprit artery only and intervention on non‐culprit artery(ies) was performed at discretion of the investigator, based on clinical status (persistent or recurrent angina), evidence of ischaemia in non‐invasive tests (perfusion scintigraphy or stress echo), angiographic severity of non‐culprit lesions and clinical relevance of the affected vessels as well as organisation standards of the participating centres.
Outcomes Primary: 12‐month revascularisation.
Secondary: in‐hospital revascularisation, reinfarction, and death. Procedural in‐hospital and total hospital cost, 12 months' follow‐up.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not mentioned in the article.
Allocation concealment (selection bias) Unclear risk Not mentioned in the article.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not mentioned in the article.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not mentioned in the article.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not mentioned in the article.
Selective reporting (reporting bias) High risk Study did not have a published protocol and was not registered on any clinical trial databases.
Other bias Unclear risk Unclear source of funding.