Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394680
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : May 27, 2011
Hebrew University of Jerusalem
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
Options for coronary revascularization include stent implantation and coronary bypass surgery. Both modalities have their unique advantages and disadvantages in terms of clinical outcomes as well as financial impact on the medical system. We wish to investigate the late results of patients undergoing coronary revascularization, the need for re-hospitalization, re-intervention, patient satisfaction as well as the financial burden on the medical system. The study will be conducted by historical prospective review of hospital records in conjunction with records of the medical insurance companies ("HMO's").

Condition or disease
Coronary Arteriosclerosis Angina Unstable Myocardial Infarction

Detailed Description:

Cardio-vascular disease is the second leading cause of death in the western world. Two modes of treatment are currently used:

Coronary Artery Bypass Graft (CABG) Percutaneous Interventions (PCIs) i.e: balloon angioplasty and stents[ bare metal (BMS) and drug eluting (DES)].

CABG is a major operation but is considered to be safe and with good quality of life in the years to follow. The initial cost of CABG is high but usually stays low thereafter.

PCI is less invasive but its downfall is a high rate of restenosis hence leading to the return of angina. The initial cost is low but due to the return of symptoms the cost increases.

The goal of DES is to lower the rate of restenosis thus reducing the need for repeat hospitalizations and procedures. The initial cost of this stent is higher than that of the BMS but still lower than that of CABG.

The goal of this study is to assess and compare the average annual cost of treatment for patients with multi-vessel disease who underwent one of the following procedures:

  1. CABG
  2. DES
  3. BMS

The information for the study is derived from the data bases of the cardiology and cardio-thoracic surgery departments at Shaarey-Zedek hospital and from those of Clalit Health Services and Kupat Holim Meuhedet.

The study design is historical prospective. The participants are insured by the above mentioned HMOs and were treated during 2000-2004.

The final sample's size will be decided on according to a pilot study with 15 patients from each of the treatment groups.

To our knowledge no studies comparing CABG and DES have yet been published. We believe that our study could become a mile stone in the process of choosing the most suitable treatment for the patient and for the health system.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.
Study Start Date : November 2006
Actual Study Completion Date : May 2007

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease and were treated during 2000-2004

Inclusion Criteria:

  • Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease with occlusion of at least 70% of at least two of the main coronary vessels.

Exclusion Criteria:

  • Non multi- vessel Disease
  • Any additional cardiac disease

    1. Valvular
    2. Low EF (<30%)
  • Liver disease - according to liver enzymes
  • Other cardiac treatment (past or immediate future)

    1. Active MI (24hrs before revascularization)
    2. Previous revascularization before beginning of follow up.

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 identifier (NCT number): NCT00394680

Sponsors and Collaborators
Shaare Zedek Medical Center
Hebrew University of Jerusalem
Layout table for investigator information
Principal Investigator: Amir Shmueli, PhD The Hebrew University, School of Public Health

Layout table for additonal information Identifier: NCT00394680    
Other Study ID Numbers: CABGvsStent-Jerusalem
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: May 27, 2011
Last Verified: May 2011
Keywords provided by Shaare Zedek Medical Center:
coronary revascularization
stent inmplantation
coronary bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Coronary Disease