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

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

Tracking Information
First Submitted Date  ICMJE October 1, 2012
First Posted Date  ICMJE October 3, 2012
Last Update Posted Date September 29, 2017
Actual Study Start Date  ICMJE December 1, 2012
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Residual ischemia [ Time Frame: 6 - to 18-month follow-up ]
≥5% residual ischemia by single photon emission computed tomography (SPECT)
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
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.
Change History Complete list of historical versions of study NCT01699048 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • 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.
  • 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
  • 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);
  • Restenosis [ Time Frame: 6- to 18-month follow-up ]
    angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%;
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
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 [ Time Frame: up to 5 years ]
  • Procedural success. Time Frame: during index hospitalization up to discharge from the hospital. 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: during index hospitalization 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
  • New York Heart Association (NYHA) class modification with respect to baseline [Time Frame: at 12 months post-procedure up to 5 years]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG
Official Title  ICMJE Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases
Intervention  ICMJE
  • 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
  • Procedure: PCI
    Multi-vessel PCI with DES
  • Procedure: CABG
    Coronary artery bypass graft (CABG) treatment
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: Hybrid (MIDCAB+PCI)
  • PCI
    Multi-vessel PCI with DES (MV-PCI group, n=50)
    Intervention: Procedure: PCI
  • CABG
    Coronary artery bypass graft (CABG) treatment (CABG group, n=50)
    Intervention: Procedure: CABG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2012)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 16, 2017
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01699048
Other Study ID Numbers  ICMJE HREVS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences
Study Sponsor  ICMJE Russian Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Russian Academy of Medical Sciences
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP