Topic: Cardiovascular
Conditions
Interventions
1. Complete Revascularisation: Staged PCI using second generation drug eluting stents of all suitable non-culprit lesions.
2. Culprit Only Revascularisation, Culprit Lesion-Only Revasc
Sponsors
Population Health Research Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women within 72 hours after successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis 2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has 2.1. at least 70% diameter stenosis (visual estimation) or 2.1. at least 50% diameter stenosis (visual estimation) with fractional flow reserve less than or equal to 0.80
Exclusion criteria
Exclusion criteria: 1. Planned revascularisation of non-culprit lesion(s) 2. Planned surgical revascularisation 3. Non-cardiovascular co-morbidity reducing life expectancy to less than 5 years 4. Any factor precluding 5 year follow up. 5. Prior coronary artery bypass graft (CABG) surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular (CV) death or new MI; Timepoint(s): hospital discharge, 30 days, 6 months, 12 months and then annually for up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether complete revascularisation reduces the composite of cardiovascular (CV) death, new Myocardial Infarction (MI) or ischaemia-driven revascularisation. 2. To determine whether the initial strategy of complete revascularisation improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life scale at 6 months and 5 years/final follow-up compared to baseline. Other: To determine whether an initial strategy of complete revascularisation is superior to an initial strategy of culprit lesion only revascularisation in reducing the composite of CV death, new MI, ischaemia-driven revascularisation or rehospitalisation for unstable angina or hospitalisation for heart failure and each component of the key secondary objectives taken separately as well as all-cause mortality, stroke, stent thrombosis, major bleeding, economic evaluation, including health resource utilization, costs and cost-effectiveness. | — |
Countries
Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Israel, Italy, Lithuania, Macedonia, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States of America
Outcome results
None listed