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Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.

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

Collaborators (595)

Chimowitz M, Derdeyn C, Fiorella D, Lynn M, Turan T, Lane B, Montgomery J, Janis S, Armstrong ME, Malloy J, Lutsep H, Barnwell S, Waters M, Hoh B, Hourihane M, Levy E, Alexandrov A, Harrigan M, Chiu D, Klucznik R, Clark J, McDougall C, Johnson M, Pride L, Lynch J, Zaidat S, Chimowitz M, Lynn M, Turan T, Lane B, Armstrong ME, Malloy J, Montgomery J, Swanson S, Cleveland J, Nizam A, Chimowitz M, Turan T, Lane B, Montgomery J, Armstrong ME, Malloy J, Helwig S, Peterson J, Lynn M, Montgomery J, Nizam A, Cotsonis G, Swanson S, Cleveland J, Lu L, Allen C, Derdeyn C, Vendt B, Cloft H, Rumboldt Z, Caplan L, Anderson D, Hart R, Bernstein R, O'Brien T, Hendrix G, Powers E, Chiaramida S, Turan T, Egan B, Lopes-Virella M, Hermayer K, Le NA, Benavente O, White C, Chimowitz M, Virgil Brown W, Lane B, Montgomery J, Le NA, Derdeyn C, Fiorella D, Barnwell S, Dion J, Meyers P, Gobin P, Zaidat S, Lane B, Chimowitz M, Williams M, Case C, Lanzino G, Moy C, Koroshetz W, Stern B, Zoarski G, Grotta J, Hess D, Johnson M, Verter J, Gotshall A, Minkin S, Caskey M, Kandl J, Steiner M, Stufflebean A, Vilardo N, Barnwell S, Lutsep H, Petersen B, Nesbit G, Clark W, Fields J, Larsen D, Enochs S, Feest K, Dugan B, Jamieson S, Hoh B, Waters M, Miller B, Khanna A, Sheehan T, Carlton L, Boyette R, Davis N, Levy E, Siddiqui A, Hourihane M, Sawyer R, Ionita C, Donovan M, Crumlish A, Hartney M, McAdoo J, Holler D, Harrigan M, Alexandrov A, Rothrock J, Lopez I, Patterson D, Cava L, Taylor T, Nelson L, Casey B, Albright K, Walker H, Chiu D, Klucznik R, Volpi J, Diaz O, Ling J, McCane D, Katz L, McDougall C, Albuquerque F, Fiorella D, Clark J, Frey J, Moguel-Cobos G, Ladha S, Kasel B, Cacciola J, Porter S, Kelly C, Honea N, Jahnke H, Pride L, Welch B, Johnson M, Lee J, Novakovic R, Hall C, Johnson K, Zaidat O, Torbey M, Book D, Lynch J, Fitzsimmons B, Helms A, Pierzchalski C, Delap J, Miller C, Brandenburg E, Das E, Farrow-Schmidt A, Budzik R, Pema P, Eubank G, Johnson K, Sample N, Taylor M, Metz W, Allison L, Campbell T, Crabtree C, Chaturvedi S, Xavier A, Rajamani K, Bhattacharya P, Madhaven R, Mada F, Sawaya K, Salowich-Palm L, Murray D, Vaphiadis D, Turk A, Chimowitz M, Turan T, Chaudry I, Turner R, Adams R, Papamitsakis N, Walker A, Starr G, Debenham E, Garry J, Peterson J, Helwig S, Kott B, Huddlestone J, Nohara A, Lynam L, Zhu Y, Barnhart M, Holsey C, Wall-Tweten M, Warner S, Sherif D, Deveshwar S, Sethi P, Dohmeier C, Yan Y, Reynolds M, Willis K, Weymann C, Champey D, Hickling W, Harbison W, Parker D, Howard A, Hammonds S, Overton A, Goodpasture T, Henderson P, Martin C, Johnson M, Woo H, Fiorella D, Perkins C, Donarummo L, Guido M, Krupp L, Coyle P, Gerber O, Fiore S, Madigan D, Baumeister M, Geronimo V, McHugh D, Heck D, Chase C, Runheim A, Kraft H, Dodds J, Greene-Chandos D, Norwood D, Whitley Y, Browning T, Burdette M, Rai A, Brooks C, Nance C, Gutmann L, Altemus P, Domico J, Power M, Weimer T, Whitescarver R, Rasmussen P, Masaryk T, Gupta R, Katzan I, Uchino K, Gebel J, Hussain M, Lu M, Bae C, Provencio J, Andrews-Hinders D, Wheeler T, Strozniak L, Tighe N, Richmond A, Toth G, Turczyk J, Mitsias P, Kole M, Katramados A, Russman A, Silver B, Sripathi N, Jones J, Hellinger F, Honeycutt D, Isa A, Bilanovic L, Brutsch B, Beaudry K, Caplan C, Basignani C, Donaldson K, Jovin T, Reddy V, Weschler L, Jankowitz B, Zaidi S, Horowitz M, Lin R, Hammer M, Jumaa M, DeCesare S, Crowley-Lisowski D, Adams A, Oakley J, Billigen J, Mawad M, Morsi H, Bershad E, Suarez J, Lopez G, Moore S, Pierce M, DeFreitas G, Elkind M, Meyers P, Willey J, Roberts J, Corporan T, Aragon Garcia R, Buciuc R, Uschmann H, Auchus A, Leacock R, Brumfield E, Bankston M, Gordy D, Tong F, Nahab F, Dion J, Cawley C, Frankel M, Gupta R, Nogueira R, Webb A, Ayala L, Hanson K, Holland E, Romano J, Yavagal D, Koch S, Aziz-Sultan M, Katsnelson M, Campo-Bustillo I, Lichtenberger M, Gobin Y, Leifer D, Riina H, Fink M, Jamieson D, Segal A, White H, Caronna J, Nikolov B, Salvaggio K, Velcheva M, Ogg M, Conners J, Lopes D, Prabhakaran S, Lee V, Shanks M, Catalano M, Griffin G, Cole T, Woods C, Hurst R, Kasner S, Weigele J, Cucchiara B, Messe S, Shafi N, Mullen M, Rose D, Rybinnik I, Sansing L, McGarvey M, Augelli E, DeSanto M, Gallatti N, Ventura L, Luciano J, Abruzzo T, Ringer A, Khatri P, Kanter D, Flaherty M, Kleindorfer D, Kempisty S, Sullivan K, Moore C, Sprafka L, Koenig C, Reinert B, Shownkeen H, Mazumdar A, Echiverri H, Bajwa R, Dzamashvili K, Sucholeiki R, Iacob M, Smith J, Lidtke S, Pastore P, Woodson K, Tarr R, Sunshine J, Sila C, Westbrook E, DeGeorgia M, Pundik S, Sundararajan S, Furlan A, Korosec D, Diorio D, Alexander M, Palestrant D, Lyden P, Miller C, Singh R, Serrano C, Ferguson E, Lin F, Kornbluth P, Zorge T, Song S, Babcock T, Smith T, Graffagnino C, Chilukuri V, Stoner J, Bombard D, Gauger L, Baxter B, Rankine D, Devlin T, Jones D, Sparks J, Gaddis D, Thacker I, Hise J, Graybeal D, Choudry R, Okai A, Broyles E, Johnson M, Smith R, Sams M, Castillo M, Zylak C, Geraghty M, Powell T, Bender W, Rawner E, Franks R, Aaron B, Cantrell T, Worrell K, Rosenwasser R, Jabbour P, Pineda C, Bell R, Brock D, August D, Simons E, Salvatore A, Wakefield M, Sheridan M, Salgado K, Furlong J, Lesley W, Lenehan R, Clark J, Wardlow R, Wulbrecht B, Carney M, Taggart S, Castillo R, Rappard G, Thompson D, Lee L, Galicia C, Cann J, Zoltzman I, Ghosalkar A, Oliveria Berndt L, Fessler R, Mick J, Kole B, Silverman B, Cullis P, Holtzman M, Warra N, Will-Murphy Y, Silverman M, Telck K, Gordon V, Kelly J, Lahey M, Zakhem N, Rieck C, Bernard J, Dibert S, Story J, Martin J, Price M, Agola J, Zweifler R, Rathbun J, Cummings S, Hollsten P, Bright S, Pryor J, Silverman S, Nogueira R, Buonanno F, Ning M, Singhal A, Rost N, Rista B, Chutinet A, Thankachan T, Pergolizzi R, Putman C, Cochran J, Lipsky R, Rosecan J, Greenberg M, John K, Restak C, Boucher K, Higashida R, Nguyen-Huynh M, Tatum J, Poisson S, Scanlon J, Yancey C, Stason S, Malek R, Sachdev H, Sachdev N, Emami M, Kelly-Tolley U, Chong B, Demaerschalk B, Aguilar M, Dodick D, Ingall T, Vargas B, Noe K, Sirven J, Drazkowski J, Boyd E, Dunshee J, Gailloud P, Wityk R, Nyquist P, Kohler B, Jones A, Moran C, Derdeyn C, Cross D, Carpenter D, Ford A, Lee J, Zazulia A, Hantler N, Newgent J, Rickmann J, Serna J, Carpenter L, Bank W, Liu A, Hsia A, Lin M, Schlosberg M, Martin J, Cota M, Fleming I.

Author information

  • 1Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery, Washington University School of Medicine, St Louis, MO, USA. Electronic address: derdeync@wustl.edu.
  • 2Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA.
  • 3Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, GA, USA.
  • 4Department of Neurosurgery, State University of New York, Stony Brook, NY, USA.
  • 5National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD, USA.
  • 6Department of Neurology, Oregon Health and Science University, Portland, OR, USA.
  • 7Department of Neurological Surgery and the Dotter Interventional Institute, Oregon Health Sciences University, Portland, OR, USA.
  • 8Departments of Neurology and Neuroscience, University of Florida, Gainesville, FL, USA.
  • 9Department of Neurosurgery, University of Florida, Gainesville, FL, USA.
  • 10Dent Neurological Institute, Buffalo, NY, USA.
  • 11Department of Neurosurgery, University of Buffalo, NY, USA.
  • 12Department of Neurology, University of Alabama, Birmingham, AL, USA.
  • 13Department of Neurosurgery, University of Alabama, Birmingham, AL, USA.
  • 14Department of Neurology, Houston Methodist Hospital, Houston, TX, USA.
  • 15Department of Radiology, Houston Methodist Hospital, Houston, TX, USA.
  • 16Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.
  • 17Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA.
  • 18Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
  • 19Departments of Radiology and Neurosurgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.
  • 20Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, USA.
  • 21Departments of Neurology, Radiology, and Neurosurgery, Medical College of Wisconsin, Milwaukee, WI.
  • 22Department of Radiology, Medical University of South Carolina, Charleston, SC, USA.
  • 23Department of Radiology, Mayo Clinic, Rochester, MN, USA.

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 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.

Copyright © 2014 Elsevier Ltd. All rights reserved.

Comment in

PMID:
24168957
[PubMed - indexed for MEDLINE]
PMCID:
PMC3971471
[Available on 2015/1/25]
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