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

This study has been completed.
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00394680
First received: October 31, 2006
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

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
Coronary Arteriosclerosis
Angina Unstable
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 700
Study Start Date: November 2006
Study Completion Date: May 2007
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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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.
  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: NCT00394680

Sponsors and Collaborators
Shaare Zedek Medical Center
Hebrew University of Jerusalem
Investigators
Principal Investigator: Amir Shmueli, PhD The Hebrew University, School of Public Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00394680     History of Changes
Other Study ID Numbers: CABGvsStent-Jerusalem
Study First Received: October 31, 2006
Last Updated: May 26, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
coronary revascularization
stent inmplantation
coronary bypass

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Coronary Disease
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014