Retrospective Study of the Impact of Drug Eluting Stents
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | May 2007 |
| End Date: | May 2008 |
| Contact: | Lynn A. Shuler, RN, MA |
| Email: | lshuler@this.org |
| Phone: | 509.474.4302 |
Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs
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.
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.
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.
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.
Inclusion Criteria:
- Coronary artery stenting between March 1, 2001 and March 30, 2006
Exclusion Criteria:
- Implanted investigational drug eluting stents
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