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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01699048
First received: October 1, 2012
Last updated: June 3, 2017
Last verified: June 2017
  Purpose
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 Intervention
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Procedure: Hybrid (MIDCAB+PCI) Procedure: PCI Procedure: CABG

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.

  • 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

  • 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

  • Reduction in ischemic myocardium [ Time Frame: 6 - to 18-month follow-up ]
    . ≥5% reduction in ischemic myocardium scan with single photon emission computed tomography (SPECT)

  • Target vessel/graft failure [ Time Frame: 9- to 15-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);

  • Restenosis [ Time Frame: 9- to 15-month follow-up ]
    angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;


Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Study Completion Date: August 2020
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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. 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. Procedural success: The treatment will be considered successful when a revascularisation in the absence of complications during the index hospitalization has been achieved; III. Procedural and post-procedural hemorrhagic complications [ Time Frame: up to discharge from the hospital ]; IV. Recovery time [ Time Frame: up to discharge from the hospital ];

The secondary endpoints:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699048

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

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     History of Changes
Other Study ID Numbers: HREVS
Study First Received: October 1, 2012
Last Updated: June 3, 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

ClinicalTrials.gov processed this record on September 19, 2017