Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS)

The final results of a randomised trial

Colin P. Derdeyn, Marc I. Chimowitz, Michael J. Lynn, David Fiorella, Tanya N. Turan, L. Scott Janis, Jean Montgomery, Azhar Nizam, Bethany F. Lane, Helmi L. Lutsep, Stanley L. Barnwell, Michael F. Waters, Brian L. Hoh, J. Maurice Hourihane, Elad I. Levy, Andrei Alexandrov, Mark R. Harrigan, David Chiu, Richard P. Klucznik, Joni M. Clark & 7 others Cameron G. McDougall, Mark D. Johnson, G. Lee Pride, John R. Lynch, Osama O. Zaidat, Zoran Rumboldt, Harry J. Cloft

Research output: Contribution to journalArticle

291 Citations (Scopus)

Abstract

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 highrisk 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.

Original languageEnglish (US)
Pages (from-to)333-341
Number of pages9
JournalThe Lancet
Volume383
Issue number9914
DOIs
StatePublished - Jan 1 2014

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Pathologic Constriction
Arteries
Stroke
Therapeutics
Angioplasty
Stents
National Institute of Neurological Disorders and Stroke
Transient Ischemic Attack
Life Style
Hemorrhage

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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

In: The Lancet, Vol. 383, No. 9914, 01.01.2014, p. 333-341.

Research output: Contribution to journalArticle

Derdeyn, CP, Chimowitz, MI, Lynn, MJ, Fiorella, D, Turan, TN, Janis, LS, Montgomery, J, Nizam, A, Lane, BF, Lutsep, HL, Barnwell, SL, Waters, MF, Hoh, BL, Hourihane, JM, Levy, EI, Alexandrov, A, Harrigan, MR, Chiu, D, Klucznik, RP, Clark, JM, McDougall, CG, Johnson, MD, Pride, GL, Lynch, JR, Zaidat, OO, Rumboldt, Z & Cloft, HJ 2014, 'Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): The final results of a randomised trial', The Lancet, vol. 383, no. 9914, pp. 333-341. https://doi.org/10.1016/S0140-6736(13)62038-3
Derdeyn, Colin P. ; Chimowitz, Marc I. ; Lynn, Michael J. ; Fiorella, David ; Turan, Tanya N. ; Janis, L. Scott ; Montgomery, Jean ; Nizam, Azhar ; Lane, Bethany F. ; Lutsep, Helmi L. ; Barnwell, Stanley L. ; Waters, Michael F. ; Hoh, Brian L. ; Hourihane, J. Maurice ; Levy, Elad I. ; Alexandrov, Andrei ; Harrigan, Mark R. ; Chiu, David ; Klucznik, Richard P. ; Clark, Joni M. ; McDougall, Cameron G. ; Johnson, Mark D. ; Pride, G. Lee ; Lynch, John R. ; Zaidat, Osama O. ; Rumboldt, Zoran ; Cloft, Harry J. / Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS) : The final results of a randomised trial. In: The Lancet. 2014 ; Vol. 383, No. 9914. pp. 333-341.
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title = "Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): The final results of a randomised trial",
abstract = "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 highrisk 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.",
author = "Derdeyn, {Colin P.} and Chimowitz, {Marc I.} and Lynn, {Michael J.} and David Fiorella and Turan, {Tanya N.} and Janis, {L. Scott} and Jean Montgomery and Azhar Nizam and Lane, {Bethany F.} and Lutsep, {Helmi L.} and Barnwell, {Stanley L.} and Waters, {Michael F.} and Hoh, {Brian L.} and Hourihane, {J. Maurice} and Levy, {Elad I.} and Andrei Alexandrov and Harrigan, {Mark R.} and David Chiu and Klucznik, {Richard P.} and Clark, {Joni M.} and McDougall, {Cameron G.} and Johnson, {Mark D.} and Pride, {G. Lee} and Lynch, {John R.} and Zaidat, {Osama O.} and Zoran Rumboldt and Cloft, {Harry J.}",
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language = "English (US)",
volume = "383",
pages = "333--341",
journal = "The Lancet",
issn = "0140-6736",
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TY - JOUR

T1 - Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS)

T2 - The final results of a randomised trial

AU - Derdeyn, Colin P.

AU - Chimowitz, Marc I.

AU - Lynn, Michael J.

AU - Fiorella, David

AU - Turan, Tanya N.

AU - Janis, L. Scott

AU - Montgomery, Jean

AU - Nizam, Azhar

AU - Lane, Bethany F.

AU - Lutsep, Helmi L.

AU - Barnwell, Stanley L.

AU - Waters, Michael F.

AU - Hoh, Brian L.

AU - Hourihane, J. Maurice

AU - Levy, Elad I.

AU - Alexandrov, Andrei

AU - Harrigan, Mark R.

AU - Chiu, David

AU - Klucznik, Richard P.

AU - Clark, Joni M.

AU - McDougall, Cameron G.

AU - Johnson, Mark D.

AU - Pride, G. Lee

AU - Lynch, John R.

AU - Zaidat, Osama O.

AU - Rumboldt, Zoran

AU - Cloft, Harry J.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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 highrisk 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.

AB - 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 highrisk 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.

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