CABG or PCI in Patients With Ischemic Cardiomyopathy

Last updated: June 20, 2024
Sponsor: Vastra Gotaland Region
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Vascular Diseases

Cardiac Disease

Treatment

Percutaneous Coronary Intervention (PCI)

Clinical Study ID

NCT05329285
EPM dnr 2021-04972
  • Ages > 18
  • All Genders

Study Summary

The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) <40%) and multi-vessel coronary artery disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years.

  2. Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment

  3. LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, ormagnetic resonance (MR) or any other recognized assessment of LVEF

  4. Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardyscore ≥ 6 on a recent (> 6 months) coronary angiogram);

  5. Heart team believes that a meaningful revascularization can be achieved by both PCIor CABG, with complete revascularization defined as residual ischemia in <10% of theleft ventricle

  6. Heart team agrees that guideline directed medical therapy (GDMT) has been initiatedfor ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized withnewly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiringrevascularization before discharge, GDMT needs to be initiated, when possible,in-hospital before randomization, with the expectation that it will be titrated tomaximally tolerated doses after revascularization

  7. Written informed consent obtained

Exclusion

Exclusion Criteria:

  1. Previous randomization in the study

  2. Decompensated heart failure requiring inotropic /adrenergic support, invasive ornon-invasive ventilation or intra-aortic balloon pump/ventricular assist devicetherapy less than 48 hours prior to randomization

  3. Recent (<1 month) type 1 myocardial infarction

  4. Recent PCI (<3 months)

  5. Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiringsurgical repair/replacement

  6. Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dualantiplatelet therapy

  7. Expected survival less than 3 years due to non-cardiac illness

  8. Circumstances likely to lead to poor treatment compliance

  9. Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems

  10. Pregnancy or woman of childbearing potential who is not sterilized or using amedically accepted form of contraception

Study Design

Total Participants: 470
Treatment Group(s): 1
Primary Treatment: Percutaneous Coronary Intervention (PCI)
Phase:
Study Start date:
September 14, 2022
Estimated Completion Date:
December 31, 2052

Study Description

Short background/ Rationale/Aim:

CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and "CABG is recommended as the first revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk". However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease.

Study objective:

To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure.

Study design:

Multicentre, open-label, randomized controlled trial

Study population:

Patients with ischemic cardiomyopathy and reduced ejection fraction.

Number of subjects:

470 subjects

Investigational treatment:

PCI

Treatment in control group:

CABG

Study endpoints:

Primary endpoint (variable):

The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization at 3 years.

Key secondary endpoint The hierarchical occurrence (in descending order of importance) at 3-year follow-up of time to death, time to stroke, time to non-procedural myocardial infarction, number of heart failure hospitalizations and 1-year Kansas City Cardiomyopathy Questionnaire (KCCQ) score; evaluated using the win ratio approach.

Secondary safety endpoints

In-hospital occurrence of the following:

  1. Death

  2. Stroke

  3. Non-procedural myocardial infarction

  4. The occurrence of in-hospital BARC ≥3 bleeding

    Time to the occurrence of the following:

  5. Mediastinitis

  6. Pericardial tamponade Other secondary endpoints

  7. Time to the occurrence of the following: A. Death, stroke or non-procedural myocardial infarction B. Death or heart failure hospitalization C. Heart failure hospitalization D. Coronary revascularization E. Death or myocardial infarction F. Death or stroke 2. Total number of days in-hospital during index hospitalization 3. Total number of days in intensive care unit during index hospitalization 4. Quality of life at 30 days and 365 days.

Connect with a study center

  • Kardiologen

    Göteborg, 41345
    Sweden

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.