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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00422968
First received: January 16, 2007
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Percutaneous coronary intervention
Procedure: coronary artery bypass graft
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • Cerebrovascular accident [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (all and ischemia-driven) [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: No ]
  • Target lesion revascularization (all and ischemia-driven) [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis in the PCI group [ Time Frame: at 30 days, 6 months, 1 year, and yearly to 5 years ] [ Designated as safety issue: Yes ]
  • Binary restenosis in both in-stent and in-segment [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Graft patency and reocclusion rate [ Time Frame: at 9 months angiographic follow-up ] [ Designated as safety issue: No ]
  • Late luminal loss in both in-stent and in-segment [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]

Enrollment: 1454
Study Start Date: March 2005
Study Completion Date: December 2013
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422968

Locations
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
St.Mary's Catholic Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Yonsei University Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Seoul National University Hospital
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
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Jung Park, M.D., Ph.D., FACC, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00422968     History of Changes
Other Study ID Numbers: 2005-0012
Study First Received: January 16, 2007
Last Updated: April 29, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
Coronary artery disease
Stent
Bypass surgery, coronary artery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014