The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG (HREVS)

Russian Academy of Medical Sciences (RAMS)

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Coronary Disease

Treatments: Procedure: Hybrid (MIDCAB+PCI); Procedure: CABG; Procedure: PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01699048

HREVS

Details and patient eligibility

About

Minimally invasive revascularization of the left anterior descending artery followed by stent implantation versus percutaneous coronary intervention or coronary artery bypass in patients with multi-vessel coronary disease

Full description

Prospective, single-center, randomized trial, intended to compare three revascularization strategies in patients with multi-vessel coronary artery disease:

Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50) Multi-vessel PCI with DES (MV-PCI group, n=50) Coronary artery bypass graft (CABG) treatment (CABG group, n=50)

PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically proven DES (Xience V, Xience Prime).

Study objective Compare three different revascularization strategies in patients with multi-vessel coronary disease

The endpoints:

The primary endpoints:

I. % ischemic myocardium on a 12-month follow-up scan with single photon emission computed tomography (SPECT);

The secondary endpoints:

I. Major adverse cardiac and cerebral events (MACCE), including (1) death, (2) non-fatal myocardial infarction (non-fatal MI), transitory ischemic attack (TIA) or stroke within 30 days, 12 months and 5-year follow-up; II. Target vessel/graft failure (for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel Revascularization (TVR); III. Restenosis = angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%; IV. Procedural success: The treatment will be considered successful when a revascularisation in the absence of complications during the index hospitalization has been achieved; V. Procedural and post-procedural hemorrhagic complications [ Time Frame: up to discharge from the hospital ]; VI. Recovery time [ Time Frame: up to discharge from the hospital ];

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Multi-vessel coronary artery disease with ≥ 70% and <96% artery stenosis (according to QCA)
2. I-IV CCS functional class of angina
3. Asymptomatic patients with stress-test documented ischemia.
4. Patients at 1 month after acute myocardial infarction
5. Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG).
6. Consensus on the treatment strategy between the members of the working group, including cardiologist, cardiac surgeon and interventional specialist.
7. Patients must have signed an informed consent.

Exclusion criteria

1. Pregnancy.
2. Acute coronary syndrome.
3. Previous CABG.
4. Previous stent thrombosis.
5. Severe comorbidity with high procedural risk for either of the studied strategies.
6. Severe peripheral artery disease.
7. Other serious diseases limiting life expectancy (e.g. oncology)
8. Inability for long-term follow-up.
9. Participation in other clinical trials.
10. Inability to take dual antithrombotic therapy.

Angiographic exclusion criteria

1. Critical stenosis (>95%) in RCA,LAD, CX or Intermediate artery, feasible for revascularization.
2. Stenosis of left main ≥ 50%.
3. Coronary artery occlusion of the major vessel.
4. Single vessel disease.
5. Need for emergency revascularization (ACS).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Hybrid group

Other group

Description:

Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with the left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)

Treatment:

Procedure: Hybrid (MIDCAB+PCI)

PCI

Other group

Description:

Multi-vessel PCI with DES (MV-PCI group, n=50)

Treatment:

Procedure: PCI

CABG

Other group

Description:

Coronary artery bypass graft (CABG) treatment (CABG group, n=50)

Treatment:

Procedure: CABG