Economic Evaluation German Drug-Eluting Stent Registry
- Conditions
- Coronary Heart Disease
- Registration Number
- NCT00866398
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.
The study "Economic Evaluation of the German Drug-Eluting Stent Registry" examines the cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, and re-intervention rates.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3973
-
Indication for coronary stent implantation
-
Additional inclusion criteria BMS cohort:
- Acute Coronary Syndrome
- Diabetes Mellitus
- Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
- 3-Vessel Disease
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cost equivalence of drug-eluting coronary stents versus bare metal stents 12 months
- Secondary Outcome Measures
Name Time Method MACCE 12 months Quality of life 12 months