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Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease (HYBRID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443754
Recruitment Status : Terminated (Lack of recruitment)
First Posted : September 30, 2011
Last Update Posted : October 3, 2016
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation

Brief Summary:

The present study is designed as a prospective, single centre, open label, observational trial.

The study will collect information about the medical care patients receive during their planned procedure(s). No new testing or procedures will be done.

Patients elected for hybrid revascularization will be asked their written consent to the use of their personal data.

Left internal mammary artery to the Left Anterior Descending Coronary Artery (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous revascularization of the other vessels in the frame of the same hospitalization.

After discharge patients will attend clinic visits at 30 days and 12 months, as per usual clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Condition or disease Intervention/treatment
Coronary Artery Disease (CAD) Procedure: LIMA-LAD surgical revascularization Procedure: PCI

Detailed Description:

Hybrid coronary revascularization integrates the positive features of both Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG), combining the durability of Left Anterior Descending Coronary Artery (LIMA) coronary bypass with the minimal invasiveness and lower risk of percutaneous intervention. Thereby it might represent a better option in a sizeable proportion of patients.

Candidate patients in whom hybrid revascularization would be advantageous are several subgroups of Coronary Artery Disease (CAD) patients that are increasing in numbers: the elderly patients with a high risk of mortality and/or morbidity for CABG, patients with significant disabilities and patients in whom treatment durability is important but a significantly invasive approach is not an option.

There are several potential advantages of the hybrid procedure over conventional CABG in selected patients. These advantages include the avoidance of cardiopulmonary bypass-related morbidity, no aortic manipulation with the LIMA-LAD with the beating heart procedure, less blood loss and decreased transfusions, a shorter recovery time than after conventional CABG and patient's preference for "minimally invasive" surgery.

The investigators hypothesize that in selected patients with diffuse coronary disease, a "hybrid" approach employing a staged revascularisation procedure may allow to lower the surgical risk, increase the completeness and effectiveness of revascularisation and, hopefully, to improve immediate and long term outcome.

To test this hypothesis, a well designed, properly sized, prospective, randomized study is needed. Available data, however, do not provide sufficient information to speculate on a clinically meaningful, yet achievable, effectiveness.

Aim of this observational study is therefore to collect more information on the target population, the clinical outcomes and optimal management in order to inform the design of a comparative effectiveness trial.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hybrid Revascularisation by Combined CABG and PCI in Multivessel Coronary Disease. An Observational Study.
Study Start Date : September 2011
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Hybrid group
Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization (LIMA-LAD surgical revascularization followed by PCI)
Procedure: LIMA-LAD surgical revascularization

Off-pump coronary artery bypass (OPCAB) in which coronary revascularization is performed on the beating heart will be followed, the choice of the technical solutions being left at the discretion of the cardiac surgeon:

  • use of a left anterior small thoracotomy (LAST), LIMA harvesting using thoracoscopic methods and manual anastomosis of the LIMA-LAD using a stabilization device;
  • minimally invasive direct coronary bypass surgery (MIDCAB). The procedures can be performed alone or in combination with one another.
Procedure: PCI

State of the art drug eluting stent (DES)-based percutaneous coronary intervention will be used by each participating site, according to current international guidelines.

Zotarolimus, everolimus or sirolimus drug-eluting stents will be used in all sites.

Primary Outcome Measures :
  1. composite of major cardiac and cerebrovascular events (MACCE) [ Time Frame: From date of inclusion until the date of first documented MACCE, assessed up to 12 months ]

    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
    • MI
    • hospitalization for repeat revascularization procedure

Secondary Outcome Measures :
  1. • Procedural success [ Time Frame: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks) ]
    successful treatment will be declared when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.

  2. • Procedural and post-procedural blood loss and number of transfusions [ Time Frame: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks) ]
  3. • Recovery time [ Time Frame: from end of intervention up to discharge from the hospital (expected average of hospital stay: 2 weeks) ]
    time to extubation; number of days in ICU; total duration of hospital admission

  4. • New York Heart Association (NYHA) class modification with respect to baseline [ Time Frame: at 12 months post-procedure ]
  5. Quality of life (SF-12 questionnaire) [ Time Frame: at 12 months post-procedure ]
  6. Length of time to return to work or normal activities [ Time Frame: from hospital discharge (index hospitalization) up to date of return to work or normal activities assessed up to 12 months after intervention ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to participating sites with clinical indication to revascularization and with clinical characteristics and multi-vessel disease amenable to hybrid revascularization

Inclusion Criteria:

Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization and fulfilling the following criteria:

  1. ≥70% left-anterior descendent (LAD) obstruction suitable for surgical revascularization using the left internal mammary artery (LIMA);
  2. patients amenable to a off-pump beating heart revascularization procedure;
  3. non-LAD coronary lesions suitable for percutaneous coronary artery intervention (PCI), as adjudicated by one interventional cardiologist and one cardiac surgeon;
  4. ≥ 70 years of age
  5. Written informed consent for the use of personal data

Exclusion Criteria:

  1. patients hemodynamically unstable;
  2. acute or recent (< 1 month) myocardial infarction;
  3. severe heart failure (NYHA Class IV);
  4. creatinine > 2.2 mg/dl;
  5. allergy to radiographic contrast;
  6. contraindication to double antiaggregation therapy (DAT) for at least 12 months;
  7. previous cardiac surgery of any type;
  8. previous thoracic surgery involving left pleural space;
  9. previous coronary stenting: within one month for BMS, within 6 months for DES;
  10. disabling stroke within previous 6 months;
  11. need for concomitant cardiac surgery during index hospitalization;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01443754

Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48010
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
Principal Investigator: Mauro Del Giglio, MD GVM Care&Research

Responsible Party: Ettore Sansavini Health Science Foundation Identifier: NCT01443754     History of Changes
Other Study ID Numbers: ESREFO04
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases