SAMMPRIS
Trial question
What is the role of aggressive medical treatment in high-risk patients with intracranial artery stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 451
451 patients (179 female, 272 male)
Inclusion criteria: patients with recent TIA or stroke related to 70-99% stenosis of a major intracranial artery
Key exclusion criteria: tandem extracranial or intracranial stenosis proximal or distal to the target intracranial stenosis, intraluminal thrombus proximal to or at the target lesion, progressive neurological signs within 24 h before enrollment, any hemorrhagic infarct within 14 days before enrollment, non-atherosclerotic causes of intracranial stenosis, and the presence of a cardiac source of embolus
Interventions
N=227 aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle modification program)
N=224 percutaneous transluminal angioplasty and stenting (with Wingspan stent, plus aggressive medical management)
Primary outcome
Rate of stroke or death within 30 days after enrollment, ischemic stroke in the territory of the qualifying artery beyond 30 days of enrollment, or any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up
5.8
14.7
14.7 %
11.0 %
7.3 %
3.7 %
0.0 %
Aggressive medical
management
Percutaneous transluminal angioplasty and
stenting
Significant
decrease ▼
NNT = 11
Significant decrease in the rate of stroke or death within 30 days after enrollment, ischemic stroke in the territory of the qualifying artery beyond 30 days of enrollment, or any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up (5.8% vs. 14.7%; ARD -8.9, 95% CI -14.41 to -3.39)
Secondary outcomes
No significant difference in stroke or death at 1 year (23% vs. 29%; ARD -6, 95% CI -13.77 to 1.77)
Significant decrease in any stroke (19% vs. 26%; ARD -7, 95% CI -13.91 to -0.09)
Borderline significant increase in death (6% vs. 6%; )
Safety outcomes
No significant differences in disabling or fatal stroke, major non-stroke hemorrhage.
Significant difference in any major hemorrhage (4% vs. 13%).
Conclusion
In patients with recent TIA or stroke related to 70-99% stenosis of a major intracranial artery, aggressive medical management was superior to percutaneous transluminal angioplasty and stenting with respect to the rate of stroke or death within 30 days after enrollment, ischemic stroke in the territory of the qualifying artery beyond 30 days of enrollment, or any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up.
Reference
Derdeyn CP, Chimowitz MI, Lynn MJ et al. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41.
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