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

May 26, 2011 updated by: Shaare Zedek Medical Center
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").

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Collaborators

Hebrew University of Jerusalem

Investigators

  • Principal Investigator: Amir Shmueli, PhD, The Hebrew University, School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Estimate)

May 27, 2011

Last Update Submitted That Met QC Criteria

May 26, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABGvsStent-Jerusalem

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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