Clinical trial NCT00627900: Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents
Official title: Model Project for the Reduction of Coronary Restenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: drug-eluting stents
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Techniker Krankenkasse
First posted: 2008-03-04
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED

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 "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


Eligibility criteria: 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

Primary outcomes:
measure: Cost equivalence of sirolimus-eluting coronary stents versus bare metal stents
timeFrame: 3,6,12,18,24, 36 months following stent implantation
Secondary outcomes:
measure: MACE (re-PCI, myocardial infarction, CABG, death)
timeFrame: 3,6,12,24,36 months after stent implantation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan N Willich, MD, MPH, MBA
role: STUDY_DIRECTOR
References:
citation: Bruggenjurgen 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. doi: 10.1007/s00059-007-3048-2.