PRAGUE‐13 2015.
Methods | RCT multi‐centre. Randomisation ratio: 1:1. Number of study centres: 6 centres in Czech Republic. |
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Participants |
Inclusion criteria: people with STEMI, angiographically successful primary PCI of culprit artery (TIMI flow grades II or III), ≥ 1 other significant stenoses of non‐culprit artery(ies) found by coronary angiography (diameter of artery ≥ 2.5 mm), enrolment ≥ 48 hours following onset of symptoms. Exclusion criteria: stenosis of the left main of left coronary artery ≥ 50%, haemodynamically significant valvular disease, people in cardiogenic shock during STEMI, haemodynamic instability, angina pectoris > grade 2 CCS lasting 1 month prior to STEMI. Diagnostic criteria MVD: ≥ 1 vessel, beside of the culprit vessel, with significant stenosis. Significant stenosis: > 70% stenosis of non‐culprit artery(ies). Sample size: complete revascularisation n = 106 and culprit‐only revascularisation n = 108. |
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Interventions |
Complete revascularisation: PCI of the culprit artery and staged intervention for the non‐culprit artery(ies) between days 3 and 40 after the index procedure. Culprit‐only revascularisation: intervention on the culprit artery only. |
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Outcomes |
Primary: composite endpoint of death, non‐fatal acute MI, and stroke. Secondary: cardiovascular death, recurrent MI, target vessel failure, progression of studied stenosis of non‐culprit artery, stroke, hospitalisation for heart failure, changes in left ventricular EF, hospitalisation for unstable angina pectoris, outcomes of questionnaire regarding angina pectoris, target vessel revascularisation, non‐culprit target lesion revascularisation. |
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Notes | Only abstract published. Protocol ID: NCT01332591. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned in the abstract or in protocol posted on www.ClinicalTrial.gov. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned in the abstract or in protocol posted on www.ClinicalTrial.gov. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label study. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Open‐label study. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts not reported in the abstract. |
Selective reporting (reporting bias) | Low risk | Abstract reported the primary outcomes indicated in the published protocol in www.ClinicalTrial.gov NCT01332591. |
Other bias | Low risk | Study was funded by a Research Grant from the Czech Ministry of Health and by The International Clinical Research Center of St. Anne's University Hospital Brno (FNUSA‐ICRC) which is funded by the European Union. |