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

NCT05534698 | Not Yet Recruiting DMC

• 1 other identifier: H-21000675
• Study Type: interventional
• Target: 1,550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IHD; LV Dysfunction

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality, stroke, MI and hospitalization for HF

  time to event

  up to 10 years with analysis after 5 years

Secondary Outcomes (1)

• Composite of occurrence of cardiovascular death or cardiovascular rehospitalization.

  up to 10 years with analysis after 5 years

Other Outcomes (1)

• combined occurrence of major bleeding, new renal filtration and dialysis

  up to 10 years with analysis after 5 years

Study Arms (2)

PCI

ACTIVE COMPARATOR

Revascularization by PCI

Procedure: PCI

CABG

ACTIVE COMPARATOR

Revascularization based on CABG.

Procedure: CABG

Interventions

PCI PROCEDURE

Revascularization by PCI

PCI

CABG PROCEDURE

Revascularization by CABG

CABG

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Study Group: lead

Study Sites (1)

Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Lars V Køber, MD

  Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Lars V Køber, MD

CONTACT

31120540; lk@heart.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Multicentre, open-label, parallel, randomized, controlled trial comparing revascularization by CABG versus by PCI in patients with severe CAD and at high risk

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): February 1, 2033
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: up to 10 years
• Access Criteria: For scientific purposes

Locations

DK (1)