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

• ClinicalTrials.gov Identifier: NCT01699048
• Recruitment Status: Completed
• First Posted: October 3, 2012
• Last Update Posted: September 29, 2017
• Sponsor: Russian Academy of Medical Sciences
• Information provided by (Responsible Party): Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Procedure: Hybrid (MIDCAB+PCI); Procedure: PCI; Procedure: CABG	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease
• Actual Study Start Date: December 1, 2012
• Actual Primary Completion Date: March 1, 2017
• Actual Study Completion Date: September 16, 2017

Arms and Interventions

Arm	Intervention/treatment
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 Name: MIDCAB
PCI; Multi-vessel PCI with DES (MV-PCI group, n=50)	Procedure: PCI; Multi-vessel PCI with DES
CABG; Coronary artery bypass graft (CABG) treatment (CABG group, n=50)	Procedure: CABG; Coronary artery bypass graft (CABG) treatment

Outcome Measures

Primary Outcome Measures :

1. Residual ischemia [ Time Frame: 6 - to 18-month follow-up ]
   ≥5% residual ischemia by single photon emission computed tomography (SPECT)

Secondary Outcome Measures :

1. MACCE [ Time Frame: up to 5 years ]

   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.

2. Procedural success [ Time Frame: up to discharge from the hospital ]
   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.
3. Procedural and post-procedural blood loss and number of transfusions [ Time Frame: up to discharge from the hospital ]
   dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC
4. Recovery time [ Time Frame: up to discharge from the hospital ]
   Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission
5. Target vessel/graft failure [ Time Frame: 6- to 18-month follow-up ]
   (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. Restenosis [ Time Frame: 6- to 18-month follow-up ]
   angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

Russian Federation

Research Institute of Complex Issues of Cardiovascular Diseases

Kemerovo, Kemerovo region, Russian Federation, 650002

Sponsors and Collaborators

Russian Academy of Medical Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr. Vladimir Ganyukov, Hybrid minimally invasive and Interventional coronary revascularization in patients with Multi-vessel coronary artery disease versus complete Endovascular Revascularisation or coronary Artery bypass graft (treatment strategies)., Russian Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01699048
• Other Study ID Numbers: HREVS
• First Posted: October 3, 2012
• Last Update Posted: September 29, 2017
• Last Verified: September 2017

Keywords provided by Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences:

multivessel PCI,MIDCAB,CABG; Hybrid coronary revascularization

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes