Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorDanish Study Group
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PCI
- CABG
Treatment groups
1,550 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov