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

Official title

Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for Revascularization in Moderate to Highs Risk Patients With Ischemic Heart Disease and Reduced Left Ventricular Ejection Fraction

Overview

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.

Detailed description

The STICH trial demonstrated a reduction in overall mortality after 10 years, but the 5-year analyses did not show significant benefits of CABG versus medical therapy. The extension of the STICH study, the STICHES study established the superiority of CABG over medical therapy for all-cause mortality (58.9% versus 66.1%; HR 0.84, 95%CI: 0.73-0.97; p = 0.02) over 9.8 years. Thus, these studies suggest that to offset the early operative risks of CABG, 10-year survival is needed. As many patients with HF and/or LVSD are elderly, both clinicians and patients are often unwilling to accept increased short-term risk even if they might eventually achieve long-term benefit, and thus not favour CABG. The available evidence suggest that PCI is feasible for patients with ischemic LVSD, and that PCI may yield long-term mortality rates like CABG with lower short-term morbidity The planned trial is a multicentre, open-label, parallel, randomized, controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk, where guidelines accept both CABG and PCI as suitableand mortality. High risk is defined as patients with LVEF \<45%, (irrespectively of clinical HF and severe renal disease), left anterior descending (LAD) disease in one- or two vessel disease, three-vessel disease with a SYNTAX score of up to 22 and left main disease with a SYNTAX score of up to 32.

The trial is powered for non-inferiorty.

Interventions

• Procedure PCI
  Revascularization by PCI
• Procedure CABG
  Revascularization by CABG

Primary outcome measures

• Composite of all-cause mortality, stroke, MI and hospitalization for HF [Time frame: up to 10 years with analysis after 5 years]

Secondary outcome measures (1)

• Composite of occurrence of cardiovascular death or cardiovascular rehospitalization. [Time frame: up to 10 years with analysis after 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Rigshospitalet, University of Copenhagen — Copenhagen

Identifiers

NCT: NCT05534698 · H-21000675

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗