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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 currently recruiting participants.
Verified October 2012 by Russian Academy of Medical Sciences
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: October 4, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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:

U.S. FDA Resources

Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • MACCE [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Recovery time [ Time Frame: up to discharge from the hospital ] [ Designated as safety issue: Yes ]
    Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission

  • • New York Heart Association (NYHA) class modification with respect to baseline [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • life quality assessed by one of the life quality questionnaires [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2013 (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 will be death, MI, stroke, or new myocardial ischemia and will be TVR and non-TVR at 30 days, 12 months and 5-year follow-up.

The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and number of transfusions, Recovery time, Heart Failure (New York Heart Association (NYHA)), life quality assessed by one of the life quality questionnaires

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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. Left main lesions.
  3. Coronary artery occlusion of the major vessel.
  4. Single vessel disease.
  5. Need for emergency revascularization (Acute MI, ACS etc.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699048

Contacts
Contact: Vladimir I Ganyukov, MD +79131273905 ganyukov@mail.ru
Contact: Vadim A Popov, MD +79134332444 drpopov@mail.ru

Locations
Russian Federation
Research Institute of Complex Issues of Cardiovascular Diseases Recruiting
Kemerovo, Kemerovo region, Russian Federation, 650002
Contact: Vladimir I Ganyukov, MD     +79131273905     ganyukov@mail.ru    
Contact: Vadim A Popov, MD     +79134332444     drpopov@mail.ru    
Principal Investigator: Vadim A Popov, MD            
Principal Investigator: Vladimir I Ganyukov, MD            
Sub-Investigator: Alexander A Shilov, MD            
Sponsors and Collaborators
Russian Academy of Medical Sciences
  More Information

No publications provided

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: October 4, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Russian Academy of Medical Sciences:
CAD,PCI,MIDCAB,CABG

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 June 18, 2013