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

ConditionsIHDLV Dysfunction
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PCI

    Procedure/Surgery

    Revascularization by PCI

  • CABG

    Procedure/Surgery

    Revascularization by CABG

Treatment groups

1,550 Participants
are divided into 2 treatment groups
Group A: PCIActive comparator 1 intervention
Group B: CABGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

time to event

Time frame
up to 10 years with analysis after 5 years

Secondary outcomes

1

Composite of occurrence of cardiovascular death or cardiovascular rehospitalization.

time to event

Time frame
up to 10 years with analysis after 5 years

Other outcomes

1

combined occurrence of major bleeding, new renal filtration and dialysis

Safety

Time frame
up to 10 years with analysis after 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Study Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: