Retrospective Study of the Impact of Drug Eluting Stents

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: NCT00487604
Recruitment Status : Unknown
Verified April 2007 by Providence Health & Services.
Recruitment status was:  Recruiting
First Posted : June 18, 2007
Last Update Posted : August 2, 2007
Information provided by:
Providence Health & Services

Brief Summary:
The purpose of this study is to determine whether the use of drug eluting stents is associated with higher rates of death, myocardial infarction, and major bleeding. In addition, the overall economic costs of implanting drug eluting stents compared to bare metal stents will be assessed.

Condition or disease
Coronary Artery Disease

Detailed Description:

A major limitation of percutaneous coronary stenting compared to coronary artery bypass grafting surgery has been the significantly higher need for repeat revascularization due to restenosis occurring at or near the stent site. By eluting a potent anti-proliferative agent from a polymer coated stent in a time-controlled manner, it has been possible to markedly inhibit intimal proliferation that results from implantation of a bare metal stent, dramatically reducing the need for future target lesion revascularization.

Recent angioscopic and autopsy studies have demonstrated markedly delayed and incomplete endothelialization following drug-eluting stent implantation. These events are rarely observed following bare metal stent implantation. In addition, drug-eluting stents have been associated with hypersensitivity reactions, which may predispose patients to subacute thrombosis. Finally, serial intra-coronary ultrasound studies demonstrate late stent mal-apposition, which is believed to create a possible nidus for thrombus formation.

By means of examining several extensive administrative databases, this study will retrospectively examine approximately 9,800 consecutive patients who underwent either bare metal or drug eluting coronary artery stenting at Sacred Heart Medical Center, Spokane, WA between March 1, 2001 and March 30, 2006. Time frame of follow-up is at least 18 months.

Comparison: The strategy of implanting stents during three time periods will be compared to each other. In the first study period which occurred prior to commercial release of the Cypher drug eluting stent, all patients received bare metal stents. The second study group will include all patients from the time frame between release of the Cypher stent and the Taxus drug eluting stent (approximately one year) after which a contractual decision was made to only utilize Taxus stents. During second time frame of corresponding to availability of the Cypher stent, about 30% of total stent cases received drug eluting stents predominately for "on label" indications. The third study group occurred during a time-frame when Taxus drug eluting stents were implanted in about 90% of overall patients including many with "off label" indications.

Study Type : Observational
Estimated Enrollment : 9800 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs
Study Start Date : May 2007
Estimated Study Completion Date : May 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Coronary artery stenting between March 1, 2001 and March 30, 2006

Exclusion Criteria:

  • Implanted investigational drug eluting stents

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): NCT00487604

Contact: Lynn A. Shuler, RN, MA 509.474.4302
Contact: Sandra J. Albritton, RN, MSN 509.474.4345

United States, Washington
Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Sandra J. Albritton, RN, MN    509-474-4345   
Contact: Lynn A. Shuler, RN, MA    509.474.4302   
Sponsors and Collaborators
Providence Health & Services
Principal Investigator: Michael E. Ring, MD Providence Health & Services Identifier: NCT00487604     History of Changes
Other Study ID Numbers: PMRC1371
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: August 2, 2007
Last Verified: April 2007

Keywords provided by Providence Health & Services:
Coronary Artery Disease
Drug Eluting Stent
Bare Metal Stent
Subacute thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases