Asymptomatic Clinical Trial
Official title:
Stenting vs. Best Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis - a Randomized Controlled Trial
Background. Carotid artery stenting (CAS) recently has become an accepted method for
treatment of patients with high-grade carotid artery stenosis, who are at an increased risk
for surgical carotid endarterectomy (CEA). The reported rates of neurological complications
of CAS substantially decreased during the past years, and the routine use of cerebral
protection devices and low profile catheter systems have further increased the procedure´s
safety. In the early 90's large surgical trials in North America and Europe (NASCET, ECST
and ACAS) demonstrated superiority of CEA compared to best medical treatment for symptomatic
and asymptomatic patients. Provided that the ongoing randomized controlled trials comparing
CAS and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable
to symptomatic and asymptomatic patients with high grade carotid stenosis. However,
particularly in asymptomatic patients, the indication for revascularisation remains
debatable. Protected CAS is associated with a very low rate of neurological complications,
which are below the AHA recommendation for treating asymptomatic patients (3%). However, the
introduction of new vascular protective medications like statins and clopidogrel during the
recent years substantially improved the spectrum of best medical treatment, and the findings
of NASCET, ECST and ACAS with respect to best medical treatment may therefore not be
applicable any more.
Study hypothesis and aims. Given the low frequency of spontaneous neurological
complications, the preferable therapeutic approach to patients with asymptomatic high grade
( > 80%) carotid artery stenoses is currently unknown. Modern best medical treatment may
manage to stabilize the atherosclerotic plaque, while CAS has the potential of resolving the
carotid stenosis. Comparative data, however, are not available as yet. We hypothesized that
protected CAS has a beneficial effect on occurrence of ipsilateral neurological
complications and major adverse cardiac events in high-risk patients with asymptomatic > 80%
internal carotid artery stenosis. Therefore, the aim of the present randomized controlled
trial was to analyze neurological and cardiovascular outcome of patients treated with
elective CAS plus best medical treatment compared to best medical treatment only.
Carotid artery stenting (CAS) recently has become an accepted method for treatment of
patients with high-grade carotid artery stenosis, who are at an increased risk for surgical
carotid endarterectomy (CEA). The reported rates of neurological complications of CAS
substantially decreased during the past years, and the routine use of cerebral protection
devices and low profile catheter systems have further increased the procedure´s safety. In
the early 90ies large surgical trials in North America and Europe (NASCET, ECST and ACAS)
demonstrated superiority of CEA compared to best medical treatment for symptomatic and
asymptomatic patients. Provided that the ongoing randomized controlled trials comparing CAS
and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable to
symptomatic and asymptomatic patients with high grade carotid stenosis. However,
particularly in asymptomatic patients, the indication for revascularisation remains
debatable. Protected CAS is associated with a very low rate of neurological complications,
which are below the AHA recommendation for treating asymptomatic patients (3%). However, the
introduction of new vascular protective medications like statins and clopidogrel during the
recent years substantially improved the spectrum of best medical treatment, and the findings
of NASCET, ECST and ACAS with respect to best medical treatment may therefore not be
applicable any more.
Given the low frequency of spontaneous neurological complications, the preferable
therapeutic approach to patients with asymptomatic high grade ( > 80%) carotid artery
stenoses is currently unknown. Modern best medical treatment may manage to stabilize the
atherosclerotic plaque, while CAS has the potential of resolving the carotid stenosis.
Comparative data, however, are not available as yet. We hypothesized that protected CAS has
a beneficial effect on occurrence of ipsilateral neurological complications and major
adverse cardiac events in high-risk patients with asymptomatic > 80% internal carotid artery
stenosis. Therefore, the aim of the present randomized controlled trial was to analyze
neurological and cardiovascular outcome of patients treated with elective CAS plus best
medical treatment compared to best medical treatment only.
SYNOPSIS
BACKGROUND:
The preferable treatment - whether revascularization or conservative - of asymptomatic
high-risk patients with > 80% internal carotid artery stenosis (NASCET criteria) is
currently unknown.
STUDY HYPOTHESIS:
We hypothesized that protected carotid artery stenting (CAS) plus best medical treatment is
associated with reduced rates of ipsilateral neurological complications and major adverse
cardiac events in high-risk patients with asymptomatic > 80% internal carotid artery
stenosis compared to best medical treatment only.
STUDY DESIGN:
The study is designed as a randomized controlled trial with 1:1 random assignment between
two treatment modalities including 300 patients within an scheduled inclusion period of 18
months. The primary and secondary study endpoints are evaluated for an initial two year
follow-up period after randomization. Secondary follow-up will be performed for 1, 1.5, 3, 5
and 10 years post randomization.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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