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

Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease

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

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Coronary Artery Disease; Coronary Disease
• Intervention / Treatment: Procedure: Hybrid (MIDCAB+PCI); Procedure: PCI; Procedure: CABG

Detailed Description

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

1. 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)
2. Multi-vessel PCI with DES (MV-PCI group, n=50)
3. 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 ];

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Kemerovo region
    • Kemerovo, Kemerovo region, Russian Federation, 650002
      • Research Institute of Complex Issues of Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Hybrid group; 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)	Procedure: Hybrid (MIDCAB+PCI); Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval; Other Names: MIDCAB
OTHER: PCI; Multi-vessel PCI with DES (MV-PCI group, n=50)	Procedure: PCI; Multi-vessel PCI with DES
OTHER: CABG; Coronary artery bypass graft (CABG) treatment (CABG group, n=50)	Procedure: CABG; Coronary artery bypass graft (CABG) treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual ischemia	≥5% residual ischemia by single photon emission computed tomography (SPECT)	6 - to 18-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.	up to 5 years
Procedural success	Procedural success: The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.	up to discharge from the hospital
Procedural and post-procedural blood loss and number of transfusions	dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC	up to discharge from the hospital
Recovery time	Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission	up to discharge from the hospital
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);	6- to 18-month follow-up
Restenosis	angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;	6- to 18-month follow-up

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences

Publications and helpful links

General Publications

• Ganyukov VI, Kochergin NA, Shilov AA, Tarasov RS, Skupien J, Kozyrin KA, Barbarash OL, Musialek P. Randomized Clinical Trial of Surgical Versus Percutaneous Versus Hybrid Multivessel Coronary Revascularization: 3 Years' Follow-Up. JACC Cardiovasc Interv. 2021 May 24;14(10):1163-1165. doi: 10.1016/j.jcin.2021.02.037. No abstract available.
• Ganyukov V, Kochergin N, Shilov A, Tarasov R, Skupien J, Szot W, Kokov A, Popov V, Kozyrin K, Barbarash O, Barbarash L, Musialek P. 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). J Interv Cardiol. 2020 Jan 3;2020:5458064. doi: 10.1155/2020/5458064. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2012
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): September 16, 2017

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (ESTIMATE): October 3, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Hybrid coronary revascularization; multivessel PCI,MIDCAB,CABG
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: HREVS