Clinical Study

Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year—Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS)

Table 3

Inclusion and exclusion criteria of the HREVS trial.

Inclusion criteriaExclusion criteria

1. Male or female ≥18 years of age
2. II–IV Canadian Cardiovascular Society functional
class of angina
3. Angiographically confirmed multivessel coronary
artery diseases involving LAD, with lesions severity
≥70% diameter stenosis (DS) by quantitative
coronary angiography (QCA), or 50–70% DS with
functional evidence of ischemia by either FFR ≤0.80 or stress SPECT
4. At least 1 month after acute MI (in patients with
history of MI)
5. Heart team-determined indication to coronary
revascularization with equal feasibility to perform complete revascularization using either of the three
methods (HCR, MVD-PCI, CABG)
6. Written informed consent for participation in the
study, including random treatment allocation and
compliance with study requirements inclusive of
follow-up visits and 12 ± 1 month SPECT followed by
control angiography
1. Acute coronary syndrome (ACS)
2. Any previous coronary revascularization (CABG,
HCR, or PCI)
3. Presence of any condition or abnormality that in
the opinion of the investigator would compromise
the safety of the patient or the quality of the data
4. Pregnancy
5. Stenosis of the left main coronary artery requiring
revascularization
6. Significant calcification or occlusion of a major
coronary vessel
7. Left ventricle aneurysm or valvular heart disease
requiring surgical management
8. Comorbidity associated with an increased
procedural risk for any of the treatment strategies or
other study procedures
9. Peripheral arterial disease with pain-free walking
distance ≤50m
10. Life expectancy ≤5 years
11. Inability to comply with dual antiplatelet therapy
(DAPT)
12. Inability to undergo follow-up procedures
including long-term follow-up
13. Participation in another clinical study