Comparison of One-stop Hybrid Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Disease

December 18, 2009 updated by: China National Center for Cardiovascular Diseases

Comparison of "One-stop" Hybrid Coronary Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Coronary Artery Disease

The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with off-pump coronary artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.

Sample size:

- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.

Design/Methodology:

- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.

Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional OPCAB.

- Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB. An expertise-based randomization will be used.

The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study.

Study intervention:

- Candidates will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shengshou Hu, M.D.
        • Principal Investigator:
          • Yuejin Yang, M.D.
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Institute of cardiovascular diseases & Fuwai hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shengshou Hu, M.D.
        • Principal Investigator:
          • Yuejin Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory);
  • LAD diseases not suitable for PCI [i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions];
  • Angiographic characteristics of non-LAD lesion(s) amiable to PCI;
  • Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
  • Evaluated by both cardiac surgeon and cardiologist together.

Exclusion Criteria:

  • Need for emergent CABG;
  • Prior CABG;
  • Prior PCI with stenting within 6 months of study entry;
  • Stroke with 6 months of study entry;
  • Overt congestive heart failure;
  • Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
  • Hemodynamic instability;
  • Situations in which complete revascularization is not possible served;
  • Allergy to radiographic contrast, aspirin or clopidogrel.
  • Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
  • Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
  • History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One-stop hybrid revasularization
Procedure: Minimally invasive direct coronary artery bypass
MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
Other Names:
  • MIDCAB
Procedure: PCI-Drug eluting stents

PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB.

Device: Polymer-based Sirolimus-Eluting Stents (SES).

Other Names:
  • PCI
Active Comparator: Off-pump coronary artery bypass
Procedure: Off-pump coronary artery bypass
Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
Other Names:
  • OPCAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall MACCE rate.
Time Frame: 30 days after procedure and 2 years after enrollment
30 days after procedure and 2 years after enrollment
Cardiac death.
Time Frame: 30 days after procedure, 1 and 2 years after enrollment
30 days after procedure, 1 and 2 years after enrollment
Documented myocardial infarction.
Time Frame: 30 days after procedure, 1 and 2 years after enrollment
30 days after procedure, 1 and 2 years after enrollment
Target lesion revascularization.
Time Frame: 30 days after procedure, 1 and 2 years after enrollment
30 days after procedure, 1 and 2 years after enrollment
Recurrence of Angina.
Time Frame: 1 and 2 years after enrollment
1 and 2 years after enrollment
Cost-effectiveness analysis.
Time Frame: 1 and 2 years after enrollment
1 and 2 years after enrollment
Quality of life.
Time Frame: 6 months, 1 and 2 years after enrollment
6 months, 1 and 2 years after enrollment
Rehospitalization.
Time Frame: 6 months, 1 and 2 years after enrollment
6 months, 1 and 2 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Study Director: Shengshou Hu, M.D., China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

December 21, 2009

Last Update Submitted That Met QC Criteria

December 18, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20091216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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