High-risk patients with intracranial artery stenosis: aggressive medical treatment with or without stenting
Early results of the SAMMPRIS ( Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis ) trial has showed that, by 30 days, 33 ( 14.7% ) of 224 patients in the stenting group and 13 ( 5.8% ) of 227 patients in the medical group had died or had a stroke ( percentages are product limit estimates ), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial.
Researchers have randomly assigned ( 1:1, stratified by centre with randomly permuted block sizes ) 451 patients with recent transient ischaemic attack or stroke related to 70-99% stenosis of a major intracranial artery to aggressive medical management ( antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme ) or aggressive medical management plus stenting with the Wingspan stent.
The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up.
Primary endpoint analysis of between-group differences with log-rank test was by intention to treat.
During a median follow-up of 32.4 months, 34 ( 15% ) of 227 patients in the medical group and 52 ( 23% ) of 224 patients in the stenting group had a primary endpoint event.
The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting ( PTAS ) group ( p=0.0252 ).
Beyond 30 days, 21 ( 10% ) of 210 patients in the medical group and 19 ( 10% ) of 191 patients in the stenting group had a primary endpoint.
The absolute differences in the primary endpoint rates between the two groups were 7.1% at year 1 ( p=0.0428 ), 6.5% at year 2 ( p=0.07 ) and 9.0% at year 3 ( p=0.0193 ).
The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke ( 26% vs 19%; p=0.0468 ) and major haemorrhage ( 13% vs 4%; p=0.0009 ).
The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up.
The findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. ( Xagena )
Derdeyn CP et al, The Lancet 2014; 383: 333-341
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