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JAMA. 2011 Nov 9;306(18):1983-92. doi: 10.1001/jama.2011.1610.

Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial.

Collaborators (539)

Powers WJ, Grubb RL Jr, Videen TO, Derdeyn CP, Papps CH, McElvany K, Counts L, Kelly C, Barnard T, Ferrari J, Davis T, Hall T, Clarke WR Jr, Adams HP Jr, Costigan M, Singletary K, Fang Y, Marmet J, Ecklund D, Wichman M, Hansen M, Peters R, Anderson D, Woolson RF, Diltz C, Lang J, Beane L, Sieren J, Zhang Y, Videen TO, Hood JT Jr, Adams HP Jr, Weir BK, Brott T, Gorelick P, Ferguson G, Marler J, Ravina B, Galpern W, Moy C, Janis S, Haley EC, Grady S, Palesch Y, Eidelberg D, Derdeyn CP, Shinawi L, Hantler N, Tyler A, Catanzaro M, Fritsch S, Dacey R, Chicoine M, Zipfel G, Davis P, Olalde H, Rogers M, Jacobs P, Hitchon P, Leira E, Howard M, Hoballah J, Ireland J, Marshall R, Slane K, Connolly ES, Festa J, Solomon R, Dhamoon M, Wiley J, Linares G, Marchidann A, Szeder V, Noskin O, Antoniello D, Liberato B, Frontera J, Prabhakaran S, Chong J, Wright C, Zuccarello M, Koenig C, Sprafka L, Flaherty M, Kissela B, Kleindorfer D, Kempinsky-Cliver S, Broderick J, Roggee C, Kanter D, Woo D, Schneider A, Ewing I, Charbel F, Watson K, Mlinarevich N, Ruland S, Sepideh AH, Grysiewicz R, Jones J, Wilson J, Glazier S, Miller C, Jenkins W, Mintz A, Craig J, Tegeler C, O'Brien K, Ching M, Ionita C, Lee-Kwen P, Chan R, Munschauer F 3rd, Parkes K, Coad ML, Wrest K, Olson K, Harrington S, Hopkins LN, Grand W, Ferguson R, Heckler E, Pereira L, Sawyer R, Budny J, Levy E, Nemeth L, Ali J, Rasmussen P, Andrews-Hinders D, Katzan I, Uchino K, Mayberg M, Gupta R, Bartholomew J, Urbain JL, Wheeler T, Strozniak L, Krisht A, Partington S, Fewell D, Schmidley J, Steinberg G, Coburn M, Luu D, Wijman C, Darsaut T, Sinclair J, Guzman R, Ciaravino A, Varga M, Biederman K, Horner T, Payner T, Redelman K, Fleck J, Scott J, Barrow D, Holland E, Nahab F, Rahimazadeh K, Waddy S, Burke S, Chimowitz M, Frankel M, Samuels O, Sailor S, Braimah J, Stark C, Lane B, Lessard N, Howlett-Smith H, Ezzedine M, Stern B, Shipp B, Hanson K, Turan T, Osman N, Ivan C, Bruno A, Biller J, Lincoln FN, Guingrich S, Micheels A, Pritz M, Fleck J, Williams L, Jones W, Sears A, Faber K, Lopez A, Chadwick L, Matthews V, Girdler M, Lawton M, Hannegan L, Smith W, Dempsey R, Winne P, Washburn M, Li A, Sattin J, Jensen M, Chacon M, Dulli D, Newman G, Geraghty M, Page N, Kish J, Chan R, Hesser K, Lownie S, Hachinski V, Frank C, Fleming L, Baptista K, Matijevic S, Jovin T, Yonas H, Uchino K, Billigen J, Kirby L, Hammer M, Jumaa M, Lin R, Malik A, Ranawat N, Reddy V, Wechsler L, Zaidi S, Ranawat N, Rothfus MA, Adelson D, Gupta R, Tayal A, Gebel J, Nemoto E, Pindzola R, Mallory Y, Thompson BG, Auer D, Persad C, Powells D, Zahuranec D, Brown D, Hickenbottom S, Rosenwasser R, Simons E, Jensen M, Bell R, Kumar M, Moussouttas M, Pineda C, August D, Veznedaroglu E, Brock D, McGinnis G, Scollon R, Hilbert K, Johnson M, Unwin H, Graybeal D, Kopitnik T, Davis L, Blair A, Samson D, Lee J, Kassab M, Martin N, Saver J, Guzy J, Haines J, Varma J, Smith H, Fiaz R, Ali L, Carmichael ST, Liebeskind D, Ovbiagele B, Vespa P, Duke K, Starkman S, Froehler M, Tenser M, Villablanca P, Miller C, Shah S, Czernin J, Suzuki S, Dobkin B, Towfighi A, Kidwell C, Fredieu A, Tremwel M, Manglona D, Zabramski J, Snyder J, Frey J, Spetzler R, Flaster M, Mahmood MA, Akins P, Byer J, Schaefer J, Wentworth D, Croopnick S, Newman L, Cabe K, Hanson S, Castle A, Nussbaum E, Kuno L, Mattson J, Yonas H, Brown A, Malkoff M, Graham G, Stack E, Kirby L, Diaz F, Fessler R, Gordon V, Jacobs B, Ogilvy C, Buckley D, Mansala J, Bruce A, Buonanno F, Greer D, Whalen M, Meyer F, Fode-Thomas N, Thalacker S, Piepgras D, Fulgham J, Atkinson J, Biller J, Chadwick L, Anderson D, Schneck M, Dafer R, Vidal SM, Duckworth E, Selman W, Zalaski G, Cwiklinski V, Sila C, Tarr R, Bambakadis N, Suarez J, Graffagnino C, Stoner J, Moore S, Friedman A, Chilikuri V, Kesler J, Watridge C, Pannell M, Miller G, Jaciewicz M, Wright L, Newell D, Kraybill BM, Likosky W, French B, Bush J, Brown A, Block J, Blanchard B, Becker K, Sekhar L, Newell D, Tanzi P, Nuxoll D, Bybee H, Cramer S, Volpi J, Bautista M, Zhang J, Chiu D, Ling J, Bledsoe D, Tenorio J, Abdulrauf S, Kane M, Richard C, Swoboda M, Cruz-Flores S, Ibata B, Fessler R, Telck K, Gordon V, Pieper D, Silverman B, Diaz F, Whapham J, Hanson S, Castle A, Nussbaum E, Sherman D, Leonard A, Moreno L, Tonarelli S, Hart R, Carolin M, Roman G, Caron JL, Benevente O, Vollmer D, Sher A, Jett S, Neely G, Wallis RA, Panizzon K, Licht E, Cheng E, Gardner R, McAdoo J, Haupt D, Riggs-Ruupp K, Kassab M, Wehner S, Majid A, Slivka A, Agriesti J, Dobbs M, Fowler A, Pettigrew LC, Vaishnar A, Ryan S, Williams S, Nichols F, Close B, Bruno A, Switzer J, Hess D, Hall C, Rogalsky-Nacca J, Wilson S, Aucutt-Walter N, Huang D, Poole R, Ostrander M, Logan W, Schroer S, Friday G, Brown J, Derdeyn CP, Lich L, Schwarz S, Gaehle G, Mantil J, Strohmeyer P, Gagermeier E, Mattmuller S, Narayanan T, Shi B, Satter M, Simmons G, Christian B, Carone M, Perkins T, Brackney M, Mountz J, Price J, Sashin D, Meltzer C, Mathis C, Abella E, Cariddi D, Finley B, Valk P, Cronin J, Tesar R, Hichwa R, Sunderland J, Watkins L, Ponto L, Van Heertum R, Simpson N, Saxena C, Lockwood A, Haka M, Chugani H, Ferguson L, Musik O, Manger T, Reiman E, Intorcia D, Reeder S, Bandy D, Giurlani T, Prouty A, Burns C, Stone C, Christian B, Converse A, Roberts A, Oakes T, Dabbs K, Mullan B, Jacobson M, Kemp B, Brinkman T, Garg P, Morton K, Stroud P, Link K, Brown-Proctor C, Fahey F, Wollenweber S, Smith H, Fox P, Hardies J, Morena L, Narayana S, Jerabek P, Mazziotta J, Woods R, Fernandez O, Jaffer N, Brady T, Fischman A, Callahan R, Correi J, Goodman M, Crowe R, Votaw J, Bremner JD, Nye J, Eary J, Krohn K, Kauno K, Lewellen B, Kimura L, Shoner S, Lewellen T, Coleman RE, Petry N.

Author information

  • 1Department of Neurology, Box 7025, Room 2131, 170 Manning Dr, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. powersw@neurology.unc.edu

Erratum in

  • JAMA. 2011 Dec 28;306(24):2672. Obviagele, Bruce [corrected to Ovbiagele, Bruce].

Abstract

CONTEXT:

Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically.

OBJECTIVE:

To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia.

DESIGN:

Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010.

SETTING:

Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majority were academic medical centers.

PARTICIPANTS:

Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. Of 195 patients who were randomized, 97 were randomized to receive surgery and 98 to no surgery. Follow-up for the primary end point until occurrence, 2 years, or termination of trial was 99% complete. No participant withdrew because of adverse events.

INTERVENTIONS:

Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Antithrombotic therapy and risk factor intervention were recommended for all participants.

MAIN OUTCOME MEASURE:

For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgical group and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization.

RESULTS:

The trial was terminated early for futility. Two-year rates for the primary end point were 21.0% (95% CI, 12.8% to 29.2%; 20 events) for the surgical group and 22.7% (95% CI, 13.9% to 31.6%; 20 events) for the nonsurgical group (P = .78, Z test), a difference of 1.7% (95% CI, -10.4% to 13.8%). Thirty-day rates for ipsilateral ischemic stroke were 14.4% (14/97) in the surgical group and 2.0% (2/98) in the nonsurgical group, a difference of 12.4% (95% CI, 4.9% to 19.9%).

CONCLUSION:

Among participants with recently symptomatic AICAO and hemodynamic cerebral ischemia, EC-IC bypass surgery plus medical therapy compared with medical therapy alone did not reduce the risk of recurrent ipsilateral ischemic stroke at 2 years.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00029146.

Comment in

PMID:
22068990
[PubMed - indexed for MEDLINE]
PMCID:
PMC3601825
Free PMC Article

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