Retrospective Study of the Impact of Drug Eluting Stents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Providence Health & Services.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00487604
First received: June 14, 2007
Last updated: August 1, 2007
Last verified: April 2007
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Estimated Enrollment: 9800
Study Start Date: May 2007
Estimated Study Completion Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Implanted investigational drug eluting stents
  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: NCT00487604

Contacts
Contact: Lynn A. Shuler, RN, MA 509.474.4302 lshuler@this.org
Contact: Sandra J. Albritton, RN, MSN 509.474.4345 salbritt@this.org

Locations
United States, Washington
Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Sandra J. Albritton, RN, MN    509-474-4345    salbritt@this.org   
Contact: Lynn A. Shuler, RN, MA    509.474.4302    lshuler@this.org   
Sponsors and Collaborators
Providence Health & Services
Investigators
Principal Investigator: Michael E. Ring, MD Providence Health & Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00487604     History of Changes
Other Study ID Numbers: PMRC1371
Study First Received: June 14, 2007
Last Updated: August 1, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014