PRAMI 2013.
Methods | RCT multi‐centre. Randomisation ratio: 1:1. Number of study centres: 5 centres in the UK. |
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Participants |
Inclusion criteria: people of any age with STEMI and MVD detected at the time of angiography. Exclusion criteria: cardiogenic shock, unable to provide consent, previous CABG, non‐infarct artery stenosis of͵≥ 50% in the left main stem or the ostial branch of both the left anterior descending and circumflex arteries (because these are indications for CABG), or if the only non‐infarct stenosis was a chronic total occlusion (because it was felt that PCI in such circumstances was contraindicated owing to a low success rate). Diagnostic criteria MVD: presence of significant stenosis in ≥ 1 coronary artery other than the culprit vessel. Significant stenosis: stenosis ≥ 50%. Sample size: complete revascularisation n = 234 and culprit‐only revascularisation n = 231. |
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Interventions |
Complete revascularisation: intervention on all, culprit and non‐culprit arteries with stenosis of ≥ 50%. Culprit‐only revascularisation: PCI of culprit vessel only, except in people with refractory angina with objective evidence of ischaemia which may require staged intervention. |
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Outcomes |
Primary: composite of death from cardiac causes, non‐fatal MI, or refractory angina. Secondary: death from non‐cardiac causes and revascularisation procedure. |
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Notes | Study was stopped earlier because of a highly significant difference between groups, favouring the complete revascularisation group. The study was funded by Bart's and the London Trust (BLT) Charitable Foundation (UK). Protocol ID: ISRCTN73028481. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was computer‐generated. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned how allocation concealment was insured. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study was open label for the participant. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Independent cardiologist and cardiac surgeon who were not notified about study‐group assignments examined specified primary and secondary outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Similar dropout rate in both groups, 4.3% in the complete vs 3.5% in the culprit‐only intervention group; however, given the small number of events, the results may be susceptible to attrition bias. |
Selective reporting (reporting bias) | Low risk | Study reported the primary outcomes indicated in the published protocol in www.isrctn.com ISRCTN73028481. |
Other bias | High risk | Early termination of the study may overestimate/underestimate certain differences. |