Dambrink and Ghani 2010.
Methods | RCT. Randomisation ratio: 2:1. Number of study centres: 1 centre in the Netherlands. |
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Participants |
Inclusion criteria: MVD with successful P‐PCI for STEMI. Exclusion criteria: urgent indication for additional revascularisation, aged > 80 years, chronic occlusion of 1 of the non‐culprit artery(ies), prior CABG, left main stenosis of ≥ 50%, restenotic lesions in non‐culprit artery(ies), chronic atrial fibrillation, limited life‐expectancy, or other factors that made complete follow‐up unlikely. Diagnostic criteria MVD: ≥ 1 significant stenosis in at least 2 major epicardial coronary arteries or the combination of a side branch and a main epicardial vessel provided that they supplied different territories. Significant stenosis: diameter ≥ 50% in luminal diameter in at least 1 view. FFR < 0.75 defined ischaemic stenosis and those were intervened only, and > 90% stenosis were intervened without FFR measurement. Sample size: complete revascularisation n = 80 and culprit‐only revascularisation n = 41. |
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Interventions |
Complete revascularisation: staged intervention on significant stenotic non‐culprit lesions compatible with ischaemia (FFR < 0.75) with plain angioplasty, BMS, or DES. Culprit‐only revascularisation: medical management after P‐PCI of culprit artery only unless ischaemic symptoms were elicited with exercise testing, dobutamine stress echocardiography, or myocardial scintigraphy, in those cases ischaemia‐guided revascularisation was performed. |
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Outcomes |
Primary: EF at 6 months. Secondary: change in EF, wall motion score, left ventricle end‐systolic and end‐diastolic volume, and MACE. |
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Notes | Early termination because of slow enrolment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed with a computer program. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned how allocation concealment was insured. |
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 | Only mentioned in the study that echocardiographic and radionucleotide data were blinded to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | In the complete revascularisation group 1.3% dropped out, vs 2.4% in the culprit‐only group. |
Selective reporting (reporting bias) | High risk | Study did not have a published protocol and was not registered on any clinical trial databases. |
Other bias | High risk | Study had early termination because of slow enrolment. Unclear source of funding. |