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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: LV Dysfunction; IHD
• Intervention / Treatment: Procedure: PCI; Procedure: CABG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars V Køber, MD; Phone Number: 31120540; Email: lk@heart.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, University of Copenhagen
    • Contact: Lars Køber, MD, D.Sci; Phone Number: 35 45 33 76; Email: LK@HEART.DK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCI; Revascularization by PCI	Procedure: PCI; Revascularization by PCI
Active Comparator: CABG; Revascularization based on CABG.	Procedure: CABG; Revascularization by CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause mortality, stroke, MI and hospitalization for HF	time to event	up to 10 years with analysis after 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of occurrence of cardiovascular death or cardiovascular rehospitalization.	time to event	up to 10 years with analysis after 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
combined occurrence of major bleeding, new renal filtration and dialysis	Safety	up to 10 years with analysis after 5 years

Collaborators and Investigators

• Sponsor: Danish Study Group
• Investigators: Study Chair: Lars V Køber, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2032
• Study Completion (Anticipated): February 1, 2033

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 11, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H-21000675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available in a RedCap database and will be shared with other researchers after final report.
• IPD Sharing Time Frame: up to 10 years
• IPD Sharing Access Criteria: For scientific purposes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No