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

29 april 2014 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1454

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: coronary artery bypass graft
Procedure: bypass-transplantaat van de kransslagader
bypass-transplantaat van de kransslagader
Experimenteel: percutaneous coronary intervention
Using silorimus eluting stent
Apparaat: Percutaneous coronary intervention
Using silorimus eluting stent

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Binaire restenose in zowel in-stent als in-segment
Tijdsspanne: bij angiografische follow-up na 9 maanden
bij angiografische follow-up na 9 maanden
All-cause mortality
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: at 9 months angiographic follow-up
at 9 months angiographic follow-up
Late luminal loss in both in-stent and in-segment
Tijdsspanne: at 9 month angiographic follow-up
at 9 month angiographic follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seung-Jung Park

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2005

Primaire voltooiing (Werkelijk)

1 november 2009

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

16 januari 2007

Eerst ingediend dat voldeed aan de QC-criteria

16 januari 2007

Eerst geplaatst (Schatting)

17 januari 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

1 mei 2014

Laatste update ingediend die voldeed aan QC-criteria

29 april 2014

Laatst geverifieerd

1 april 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2005-0012

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