RecruitingNot ApplicableNCT05761067

STICH-3.0 International Trial Consortium

The CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH) 3.0 International Trial Consortium

Sponsor

Vastra Gotaland Region

Enrollment

2,800 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

Heart Failure Coronary Artery Disease

Summary

The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD. Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and analyzed. The primary endpoint is all-cause mortality.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age \>18 years
LVEF ≤40%
Extensive coronary artery disease (typically defined as a British Cardiovascular Intervention Society jeopardy score of ≥6, on a scale from 0 to 12, with higher scores indicating greater extent of disease).

Exclusion Criteria7

Decompensated heart failure 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;
Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) indicating the need for surgical repair/replacement;
Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy;
Pregnancy;
Circumstances likely to lead to poor treatment adherence;
STEMI within 72 hours;
PCI within 3 months.