Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease (PRECOMBAT)

April 29, 2014 updated by: Seung-Jung Park

PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease

The primary objective of the PRE-COMBAT trial is:

To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) compared with bypass surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not inferior to the standard strategy (bypass surgery).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite bypass surgery has been considered as the standard strategy for the treatment of unprotected left main coronary artery (LMCA) lesions, several studies have demonstrated that percutaneous coronary intervention (PCI) of the unprotected LMCA is feasible and appears to be an alternative strategy in selected patients. However, the safety and efficacy of PCI in patients with unprotected LMCA stenosis are still a matter of debate.

Previous studies have demonstrated the safety and feasibility of unprotected LMCA intervention using bare metal stents (BMS). There was a favorable initial outcome after LMCA intervention using BMS in low-risk patients. However, in-stent restenosis after BMS implantation has emerged as the interference to widely perform PCI for unprotected LMCA lesions and the most important reason for selection of bypass surgery as the first choice for treating LMCA stenosis. In-stent restenosis in these patients not only influences long-term survival, but also make repeat intervention more complex. Despite endeavors to decrease in-stent restenosis after LMCA intervention using BMS, such as aggressive debulking atherectomy, the restenosis rate still remains at 20-30%. The sirolimus-eluting stent (SES) (Cypher, Cordis, Johnson & Johnson Corp, Miami, Florida) markedly decreases in-stent restenosis in elective patients with relatively simple coronary lesions. In real-world practice using SES, patients undergoing SES implantation were treated with a less restrictive interventional approach. However, the results are very promising similar to the randomized controlled trials. These findings warrant new studies to compare the efficacy of SES for more complex lesion subsets including LMCA disease with coronary artery bypass graft (CABG).

Study Type

Interventional

Enrollment (Actual)

1454

Phase

  • Phase 3

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

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Yonsei University Medical Center
      • Seoul, Korea, Republic of
        • St.Mary's Catholic Medical Center
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient must be at least 18 years of age.
  • Significant de novo left main stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation)
  • Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and bypass surgery
  • Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:

    • Heparin
    • Aspirin
    • Both Clopidogrel and TIclopidine
    • Sirolimus, paclitaxel, ABT 578
    • Stainless steel and/or
    • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
  • Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
  • Any previous PCI within 1 year
  • Previous bypass surgery
  • Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
  • Intention to treat more than one totally occluded major epicardial vessel
  • Acute MI patients within 1 week
  • Patients with EF<30%.
  • Patients with cardiogenic shock
  • Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
  • Creatinine level > 2.0mg/dL or dependence on dialysis.
  • Severe hepatic dysfunction (AST and ALT > 3 times upper normal reference values).
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  • Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • Subject unable or unwilling to follow-up with visits required by protocol
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

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
Active Comparator: coronary artery bypass graft
Procedure: coronary artery bypass graft
coronary artery bypass graft
Experimental: percutaneous coronary intervention
Using silorimus eluting stent
Device: Percutaneous coronary intervention
Using silorimus eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization
Time Frame: one-year after treatment
one-year after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Binary restenosis in both in-stent and in-segment
Time Frame: at 9 month angiographic follow-up
at 9 month angiographic follow-up
All-cause mortality
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Cardiac death
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Myocardial infarction
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Cerebrovascular accident
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Target vessel revascularization (all and ischemia-driven)
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Target lesion revascularization (all and ischemia-driven)
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Stent thrombosis in the PCI group
Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years
at 30 days, 6 months, 1 year, and yearly to 5 years
Graft patency and reocclusion rate
Time Frame: at 9 months angiographic follow-up
at 9 months angiographic follow-up
Late luminal loss in both in-stent and in-segment
Time Frame: at 9 month angiographic follow-up
at 9 month angiographic follow-up

Collaborators and Investigators

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

Sponsor

Seung-Jung Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 16, 2007

First Submitted That Met QC Criteria

January 16, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0012

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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