ArticlesAggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial
Introduction
Intracranial atherosclerosis is a common cause of stroke and is associated with a high risk of recurrent stroke, especially in patients with a recent stroke or transient ischaemic attack and severe arterial stenosis.1, 2, 3, 4 The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was designed to assess whether percutaneous transluminal angioplasty and stenting (PTAS) plus aggressive medical treatment is more effective than aggressive medical treatment alone in high-risk patients with this disease.5 Enrolment in SAMMPRIS began on Nov 25, 2008, but was stopped for safety concerns on April 5, 2011, because the 30-day rate of stroke and death was higher in the PTAS group.6
When enrolment was stopped, fewer than half the 451 patients had been followed up for longer than 1 year.6 Since then, patients in both treatment groups have been followed up for 2 more years to establish whether the early benefit in the medical group would persist over longer follow-up, or whether the medical group would have a high incidence of late strokes that would eliminate the early efficacy gap between the two groups. In this Article, we report the final results of the SAMMPRIS trial.
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Patients and study design
The trial design and early results are available elsewhere.5, 6, 7 SAMMPRIS was a randomised, superiority, multi-centre, clinical trial funded by the National Institute of Neurological Disorders and Stroke (NINDS). The US Food and Drug Administration (FDA) issued an Investigational Device Exemption to do the study with the Wingspan stent system (Stryker Neurovascular, Fremont, CA, USA; formerly Boston Scientific Neurovascular),8 which had been approved under a Humanitarian Device Exemption in
Results
Between Nov 25, 2008, and March 31, 2011, we randomly assigned 451 patients to treatment: 227 to the medical group and 224 to the PTAS group (figure 1). Baseline characteristics were much the same between the two groups (table 1). The median duration of follow-up in all patients was 32·4 months (IQR 24·2–40·5; range 0 months to 52·6 months). A larger proportion of patients in the medical group were lost to follow-up or withdrew consent than in the PTAS group (24 [11%] of 227 vs 10 [5%] of 224;
Discussion
The early benefit of aggressive medical treatment compared with PTAS in high-risk patients with intracranial arterial stenosis persisted over a median duration of 32·4 months of follow-up in this trial. Although we cannot rule out the possibility that longer follow-up would have shown less benefit from medical treatment alone, we think this possibility is unlikely because there was no suggestion that the efficacy gap between the two groups narrowed over time—the absolute risk reduction from
References (30)
- et al.
Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial
J Stroke Cerebrovasc Dis
(2011) - et al.
Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia
Am J Cardiol
(2004) - et al.
Clopidogrel with aspirin in acute minor stroke or transient ischemic attack
N Engl J Med
(2013) - et al.
Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis
Lancet
(2003) Mechanisms of ischemic stroke secondary to large artery atherosclerotic disease
Neuroimaging Clin N Am
(2007)- et al.
Detection of high-risk atherosclerotic plaque: report of the NHLBI Working Group on current status and future directions
JACC Cardiovasc Imaging
(2012) - et al.
Large artery intracranial occlusive disease: a large worldwide burden but a relatively neglected frontier
Stroke
(2008) Intracranial atherosclerosis: current concepts
Stroke
(2011)- et al.
Long-term mortality and recurrent stroke risk among Chinese stroke patients with predominant intracranial atherosclerosis
Stroke
(2003) - et al.
Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis
Circulation
(2006)