DANAMI‐3‐PRIMULTI 2015.
Methods | RCT multi‐centre. Randomisation ratio: 1:1. Number of study centres: 2 centres in Denmark. |
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Participants |
Inclusion criteria: chest pain < 12 hours' duration and ST elevation > 0.1 mV in at least 2 contiguous leads and with diameter stenosis of > 50% in ≥ non‐culprit artery(ies). Exclusion criteria: intolerance to contrast media, anticoagulant, antithrombotic drugs, unconsciousness or cardiogenic shock, stent thrombosis, indications for CABG, or increased bleeding risk. Diagnostic criteria MVD: significant stenosis in ≥ 1 of the non‐culprit artery(ies) or their major side branches in addition to that in the culprit artery. Significant stenosis: > 50% stenosis visually in arteries > 2 mm diameter and FFR ≤ 0.8 or > 90% stenosis visually regardless FFR measurement. Sample size: complete revascularisation n = 314 and culprit‐only revascularisation n = 313. |
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Interventions |
Complete revascularisation: PCI of culprit and in a second intervention 48 hours after P‐PCI and before discharge, FFR‐guided PCI in all non‐culprit significant stenotic lesions and > 90% stenotic despite FFR measurement. Culprit‐only revascularisation: Intervention on the culprit‐only. |
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Outcomes |
Primary: composite of all‐cause mortality, non‐fatal MI, and ischaemia‐driven (subjective or objective) revascularisation of lesions in non‐culprit artery(ies) 1 year' follow‐up. Secondary: all‐cause mortality, non‐fatal MI, cardiac death, urgent or non‐urgent PCI of lesions in non‐culprit artery(ies). |
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Notes | Protocol ID: NCT01960933. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed electronically via a centralised web‐based system. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned how allocation concealment was insured. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Even though the study was open label there was an independent events committee that adjudicated all events. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | In the complete revascularisation group around 0.3% dropped out, while in the culprit‐only group all participants completed the study. |
Selective reporting (reporting bias) | Low risk | Study reported the primary outcomes indicated in the published protocol in www.ClinicalTrial.gov NCT01960933. |
Other bias | Low risk | Study was funded by national funding institution (Danish Agency of Science, Technology and Innovation and Danish Council for Strategic Research) and the funding institution was not involved in the study other than economically. |