Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients

Launched by DANISH STUDY GROUP · Sep 6, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different heart procedures for patients who have severe coronary artery disease (CAD) and related heart problems, specifically those with left ventricular dysfunction (a type of heart weakness). The trial will compare two treatment options: PCI (Percutaneous Coronary Intervention, a less invasive procedure) and CABG (Coronary Artery Bypass Grafting, a more traditional surgery). Researchers want to find out if PCI is just as effective as CABG in preventing death and other serious heart issues in patients who are considered at moderate to high risk.

To participate in this trial, you must be at least 18 years old and have a specific type of heart weakness (measured by a left ventricular ejection fraction of less than 45%) and severe coronary artery disease. Your doctor must believe that either procedure could significantly help you. However, some patients may not be eligible if they have recently had a serious heart event, need certain types of heart support, or have other serious health issues. If you join the trial, you will be randomly assigned to receive either PCI or CABG, and your progress will be closely monitored to see how well the treatments work. This trial is important because it aims to improve care for patients with complex heart conditions who may not always receive the treatment they need.

Gender

ALL

Eligibility criteria

• 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