Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.
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|ClinicalTrials.gov Identifier: NCT00394680|
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : May 27, 2011
|Condition or disease|
|Coronary Arteriosclerosis Angina Unstable Myocardial Infarction|
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:
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|
|Estimated Enrollment :||700 participants|
|Official Title:||Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||May 2007|
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 ClinicalTrials.gov identifier (NCT number): NCT00394680
|Principal Investigator:||Amir Shmueli, PhD||The Hebrew University, School of Public Health|