Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction (MI), stroke or hospitalization for HF. To compare revascularization by PCI versus by CABG, we will perform a multicentre, open-label, parallel, randomized, controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics, where guidelines acknowledge that both PCI and CABG are relevant treatment options.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years
* LVEF\<45% with or without HF medication
* Heart team believes that a meaningful revascularization can be achieve both by PCI and by CABG
* Patients with severe CAD, where guidelines suggest equipoise between PCI and CABG
Exclusion Criteria:
* Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ ventricular assist device therapy less than 48 hours prior to randomization
* Recent (\< 1 month) ST-elevation myocardial infarction
* Recent (\< 1 month) type 2 myocardial infarction ▪ Valvular heart disease or any other cardiac conditions (for example, left ventricular aneurysm) indicating the need for surgical repair/replacement
* Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
* Pregnancy
Primary outcome measure(s)
Composite of all-cause mortality, stroke, MI and hospitalization for HF — up to 10 years with analysis after 5 years time to event
Trial sites (1)
Facility
City
Region
Status
Rigshospitalet, University of Copenhagen
Copenhagen
Denmark
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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