Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents

Coronary Artery Disease Clinical Trial

— GERSHWIN  

Official title:

Model Project for the Reduction of Coronary Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627900
• Other study ID #: EK-Vorgang: Verschiedenes
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2008
• Last updated: February 24, 2008
• Start date: April 2003

Study information

• Verified date: February 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) 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, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines.

In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care.

In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 958
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for implantation of a coronary stent

• de novo lesions < or = 30 mm in patients with diabetes

• de novo lesions 12-30 mm or RVD 2.5-3.00 mm in patients without diabetes

Exclusion Criteria:

• acute MI

• lesion length >30 mm

• in-stent restenosis

• distal lesion in RVD < 2.25 mm

• lesion in left main or bypass vessel

• contraindication to Clopidogrel

Study Design

Allocation: Non-Randomized

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• bare metal stent
implantation of a bare metal stent
• Cypher-Stent (Implantation of a sirolimus-eluting stent)
Implantation of a sirolimus-eluting stent

Locations

Country	Name	City	State
Germany	Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Techniker Krankenkasse

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Brüggenjürgen B, McBride D, Bode C, Hamm CW, Kuck KH, Willich SN. Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study. Herz. 2007 Dec;32(8):650-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents		3,6,12,18,24, 36 months following stent implantation	No
Secondary	MACE (re-PCI, myocardial infarction, CABG, death)		3,6,12,24,36 months after stent implantation	No