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

29 de abril de 2014 actualizado por: 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).

Descripción general del estudio

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Actual)

1454

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: coronary artery bypass graft
cirugía de revascularización coronaria
Experimental: percutaneous coronary intervention
Using silorimus eluting stent
Using silorimus eluting stent

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization
Periodo de tiempo: one-year after treatment
one-year after treatment

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Reestenosis binaria tanto en el stent como en el segmento
Periodo de tiempo: a los 9 meses de seguimiento angiográfico
a los 9 meses de seguimiento angiográfico
All-cause mortality
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: at 9 months angiographic follow-up
at 9 months angiographic follow-up
Late luminal loss in both in-stent and in-segment
Periodo de tiempo: at 9 month angiographic follow-up
at 9 month angiographic follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2005

Finalización primaria (Actual)

1 de noviembre de 2009

Finalización del estudio (Actual)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

16 de enero de 2007

Primero enviado que cumplió con los criterios de control de calidad

16 de enero de 2007

Publicado por primera vez (Estimar)

17 de enero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2014

Última verificación

1 de abril de 2014

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre cirugía de revascularización coronaria

  • Meshalkin Research Institute of Pathology of Circulation
    Reclutamiento
    Enfermedad de la arteria coronaria | Cirugía | Fracaso del injerto | Estenosis de la arteria coronaria | Isquemia cardiaca
    Federación Rusa
3
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