Coronary Artery Disease Clinical Trial
Official title:
Model Project for the Reduction of Coronary Restenosis
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
n/a
Allocation: Non-Randomized
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