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Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial

Derdeyn, Colin P, Prof ; Chimowitz, Marc I, Prof ; Lynn, Michael J, MS ; Fiorella, David, Prof ; Turan, Tanya N, MD ; Janis, L Scott, PhD ; Montgomery, Jean, RN ; Nizam, Azhar, MS ; Lane, Bethany F, RN ; Lutsep, Helmi L, Prof ; Barnwell, Stanley L, MD ; Waters, Michael F, MD ; Hoh, Brian L, MD ; Hourihane, J Maurice, MD ; Levy, Elad I, Prof ; Alexandrov, Andrei V, Prof ; Harrigan, Mark R, MD ; Chiu, David, Prof ; Klucznik, Richard P, MD ; Clark, Joni M, MD ; McDougall, Cameron G, Prof ; Johnson, Mark D, MD ; Pride, G Lee, MD ; Lynch, John R, MD ; Zaidat, Osama O, Prof ; Rumboldt, Zoran, Prof ; Cloft, Harry J, Prof

The Lancet (British edition), 2014-01, Vol.383 (9914), p.333-341 [Revista revisada por pares]

Kidlington: Elsevier Ltd

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Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial
Autor: Derdeyn, Colin P, Prof ; Chimowitz, Marc I, Prof ; Lynn, Michael J, MS ; Fiorella, David, Prof ; Turan, Tanya N, MD ; Janis, L Scott, PhD ; Montgomery, Jean, RN ; Nizam, Azhar, MS ; Lane, Bethany F, RN ; Lutsep, Helmi L, Prof ; Barnwell, Stanley L, MD ; Waters, Michael F, MD ; Hoh, Brian L, MD ; Hourihane, J Maurice, MD ; Levy, Elad I, Prof ; Alexandrov, Andrei V, Prof ; Harrigan, Mark R, MD ; Chiu, David, Prof ; Klucznik, Richard P, MD ; Clark, Joni M, MD ; McDougall, Cameron G, Prof ; Johnson, Mark D, MD ; Pride, G Lee, MD ; Lynch, John R, MD ; Zaidat, Osama O, Prof ; Rumboldt, Zoran, Prof ; Cloft, Harry J, Prof
Materias: Adult ; Aged ; Aged, 80 and over ; Angioplasty - adverse effects ; Angioplasty - methods ; Aspirin - therapeutic use ; Biological and medical sciences ; Blood pressure ; Carotid Stenosis - complications ; Carotid Stenosis - therapy ; Cholesterol ; Clopidogrel ; Drug therapy ; Female ; Follow-Up Studies ; General aspects ; Humans ; Internal Medicine ; Intracranial Arteriosclerosis - complications ; Intracranial Arteriosclerosis - therapy ; Ischemic Attack, Transient - etiology ; Ischemic Attack, Transient - prevention & control ; Male ; Medical sciences ; Middle Aged ; Platelet Aggregation Inhibitors - adverse effects ; Platelet Aggregation Inhibitors - therapeutic use ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Risk factors ; Secondary Prevention ; Single-Blind Method ; Stents ; Stroke - etiology ; Stroke - prevention & control ; Ticlopidine - analogs & derivatives ; Ticlopidine - therapeutic use ; Treatment Outcome ; Veins & arteries
Es parte de: The Lancet (British edition), 2014-01, Vol.383 (9914), p.333-341
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SourceType-Scholarly Journals-1
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content type line 23
Authors contributed equally
CPD and MIC contributed equally.
Members listed in the appendix
Descripción: Summary Background Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial 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. Methods We 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. This study is registered with ClinicalTrials.gov , number NCT 00576693. Findings 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 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (–0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%]of 224 patients vs 10 [4%] of 227 patients; p=0·0009). Interpretation 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. Our 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. Funding National Institute of Neurological Disorders and Stroke (NINDS) and others.
Editor: Kidlington: Elsevier Ltd
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Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial

Kidlington: Elsevier Ltd

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