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

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ClinicalTrials.gov Identifier: NCT00422968
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Percutaneous coronary intervention Procedure: coronary artery bypass graft Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1454 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease
Study Start Date : March 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: coronary artery bypass graft
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00422968


Locations
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Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
St.Mary's Catholic Medical Center
Seoul, Korea, Republic of
Yonsei University Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
Investigators
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Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seung-Jung Park, M.D., Ph.D., FACC, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00422968    
Other Study ID Numbers: 2005-0012
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
Coronary artery disease
Stent
Bypass surgery, coronary artery
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases