Document Detail


Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial.
MedLine Citation:
PMID:  22068990     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
William J Powers; William R Clarke; Robert L Grubb; Tom O Videen; Harold P Adams; Colin P Derdeyn;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  JAMA     Volume:  306     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-09     Completed Date:  2011-11-15     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1983-92     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00029146
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MeSH Terms
Descriptor/Qualifier:
Aged
Anastomosis, Surgical
Brain / blood supply
Brain Ischemia / complications,  drug therapy,  radionuclide imaging,  surgery*
Carotid Artery, Internal / pathology*
Carotid Stenosis / complications,  radionuclide imaging,  surgery*
Early Termination of Clinical Trials
Female
Hemodynamics
Humans
Male
Middle Aged
Middle Cerebral Artery / surgery*
Positron-Emission Tomography
Recurrence
Regional Blood Flow
Stroke / etiology,  prevention & control*
Temporal Arteries / surgery*
Grant Support
ID/Acronym/Agency:
K24 MH076955/MH/NIMH NIH HHS; NS39526/NS/NINDS NIH HHS; NS41895/NS/NINDS NIH HHS; NS42157/NS/NINDS NIH HHS; U01 NS042167/NS/NINDS NIH HHS
Investigator
Investigator/Affiliation:
William J Powers / ; Robert L Grubb / ; Tom O Videen / ; Colin P Derdeyn / ; Carol Hess Papps / ; Karen McElvany / ; Lydia Counts / ; Claudia Kelly / ; Tori Barnard / ; Jessica Ferrari / ; Tena Davis / ; Tracy Hall / ; William R Clarke / ; Harold P Adams / ; Michele Costigan / ; Ken Singletary / ; Yi Fang / ; John Marmet / ; Dixie Ecklund / ; Michelle Wichman / ; Michael Hansen / ; Richard Peters / ; Diane Anderson / ; Robert F Woolson / ; Cynthia Diltz / ; Julie Lang / ; Laura Beane / ; Jeri Sieren / ; Ying Zhang / ; Tom O Videen / ; John T Hood / ; Harold P Adams / ; Bryce K Weir / ; Thomas Brott / ; Philip Gorelick / ; Gary Ferguson / ; John Marler / ; Bernard Ravina / ; Wendy Galpern / ; Claudia Moy / ; Scott Janis / ; E Clarke Haley / ; Sean Grady / ; Yuko Palesch / ; David Eidelberg / ; Colin P Derdeyn / ; Lina Shinawi / ; Nancy Hantler / ; Amber Tyler / ; Mary Catanzaro / ; Susie Fritsch / ; Ralph Dacey / ; Michael Chicoine / ; Gregory Zipfel / ; Patricia Davis / ; Heena Olalde / ; Marge Rogers / ; Pam Jacobs / ; Patrick Hitchon / ; Enrique Leira / ; Matthew Howard / ; Jamal Hoballah / ; Jennifer Ireland / ; Randolph Marshall / ; Kevin Slane / ; E Sander Connolly / ; Joanne Festa / ; Robert Solomon / ; Mandip Dhamoon / ; Joshua Wiley / ; Guillermo Linares / ; Adrian Marchidann / ; Viktor Szeder / ; Olga Noskin / ; Dan Antoniello / ; Bernardo Liberato / ; Jennifer Frontera / ; Shyam Prabhakaran / ; J Chong / ; Clinton Wright / ; Mario Zuccarello / ; Carolyn Koenig / ; Lynn Sprafka / ; Matthew Flaherty / ; Brett Kissela / ; Dawn Kleindorfer / ; Suzanne Kempinsky-Cliver / ; Joseph Broderick / ; Collkeen Roggee / ; Daniel Kanter / ; Daniel Woo / ; Alexander Schneider / ; Irene Ewing / ; Fady Charbel / ; Kerriem Watson / ; Nadda Mlinarevich / ; Sean Ruland / ; Amin-Hanjani Sepideh / ; Rebecca Grysiewicz / ; Julie Jones / ; John Wilson / ; Steven Glazier / ; Charlottte Miller / ; Wendy Jenkins / ; Akiva Mintz / ; Jeffrey Craig / ; Charles Tegeler / ; Kathleen O'Brien / ; Marilou Ching / ; Catalina Ionita / ; Peterkin Lee-Kwen / ; Richard Chan / ; Frederick Munschauer / ; Kathleen Parkes / ; Mary Lou Coad / ; Kathleen Wrest / ; Karen Olson / ; Sharon Harrington / ; L Nelson Hopkins / ; Walter Grand / ; Richard Ferguson / ; E Marl Heckler / ; Lorraine Pereira / ; Robert Sawyer / ; James Budny / ; Eldad Levy / ; Lynn Nemeth / ; Jameela Ali / ; Peter Rasmussen / ; Doreen Andrews-Hinders / ; Irene Katzan / ; Ken Uchino / ; Marc Mayberg / ; Rishi Gupta / ; John Bartholomew / ; Jean-Luc Urbain / ; Terese Wheeler / ; Lori Strozniak / ; Ali Krisht / ; Sharon Partington / ; Deborah Fewell / ; James Schmidley / ; Gary Steinberg / ; Maria Coburn / ; Desiree Luu / ; Christine Wijman / ; Tim Darsaut / ; John Sinclair / ; Ralph Guzman / ; Anna Ciaravino / ; Monika Varga / ; Kathleen Biederman / ; Terry Horner / ; Troy Payner / ; Kathy Redelman / ; James Fleck / ; John Scott / ; Daniel Barrow / ; Emilee Holland / ; Fadi Nahab / ; Kathryn Rahimazadeh / ; Salina Waddy / ; Sally Burke / ; Marc Chimowitz / ; Michael Frankel / ; Owen Samuels / ; Sharion Sailor / ; Janey Braimah / ; Charlene Stark / ; Bethany Lane / ; Nicole Lessard / ; Harriet Howlett-Smith / ; Mustaffa Ezzedine / ; Barney Stern / ; Betty Shipp / ; Kate Hanson / ; Tanya Turan / ; Naema Osman / ; Christina Ivan / ; Askiel Bruno / ; Jose Biller / ; Flossy Nabila Lincoln / ; Sandy Guingrich / ; Angi Micheels / ; Michael Pritz / ; J D Fleck / ; Linda Williams / ; William Jones / ; Alison Sears / ; Kelley Faber / ; Alfredo Lopez / ; Linda Chadwick / ; Vincent Matthews / ; Michael Girdler / ; Michael Lawton / ; Lisa Hannegan / ; Wade Smith / ; Robert Dempsey / ; Pam Winne / ; M J Washburn / ; Alice Li / ; Justin Sattin / ; Matthew Jensen / ; Marcus Chacon / ; Douglas Dulli / ; George Newman / ; Madlein Geraghty / ; Nicole Page / ; Jamie Kish / ; Richard Chan / ; Kimberly Hesser / ; Steven Lownie / ; Vladimir Hachinski / ; Connie Frank / ; Lorraine Fleming / ; Karen Baptista / ; Suzan Matijevic / ; Tudor Jovin / ; Howard Yonas / ; Ken Uchino / ; Julia Billigen / ; Lori Kirby / ; Maxim Hammer / ; Mouhammad Jumaa / ; Ridwan Lin / ; Amer Malik / ; Nishant Ranawat / ; Vivek Reddy / ; Lawrence Wechsler / ; Syed Zaidi / ; Nishant Ranawat / ; Mary Ann Rothfus / ; David Adelson / ; Rishi Gupta / ; Ashis Tayal / ; James Gebel / ; Edwin Nemoto / ; Ronda Pindzola / ; Yvette Mallory / ; B Gregory Thompson / ; Donna Auer / ; Carol Persad / ; Dominique Powells / ; Darin Zahuranec / ; Devin Brown / ; Susan Hickenbottom / ; Robert Rosenwasser / ; Ellen Simons / ; Maureen Jensen / ; Rodney Bell / ; Monisha Kumar / ; Michael Moussouttas / ; Carissa Pineda / ; Deborah August / ; Erol Veznedaroglu / ; David Brock / ; Gerri McGinnis / ; Rachel Scollon / ; Kathleen Hilbert / ; Mark Johnson / ; Hal Unwin / ; Dion Graybeal / ; Thomas Kopitnik / ; Lisa Davis / ; April Blair / ; Duke Samson / ; Jessica Lee / ; Mounzer Kassab / ; Neil Martin / ; Jeffrey Saver / ; Judith Guzy / ; Jill Haines / ; Jennifer Varma / ; Hannah Smith / ; Rana Fiaz / ; Latisha Ali / ; S Thomas Carmichael / ; David Liebeskind / ; Bruce Ovbiagele / ; Bruce Obviagele / ; Paul Vespa / ; Kimberly Duke / ; Sid Starkman / ; Michael Froehler / ; Matthew Tenser / ; Pablo Villablanca / ; Chad Miller / ; Samer Shah / ; Johannes Czernin / ; Suichi Suzuki / ; Bruce Dobkin / ; Amytis Towfighi / ; Chelsea Kidwell / ; Andre Fredieu / ; Margaret Tremwel / ; Donna Manglona / ; Joseph Zabramski / ; JoAnn Snyder / ; James Frey / ; Robert Spetzler / ; Murray Flaster / ; M Asim Mahmood / ; Paul Akins / ; John Byer / ; John Schaefer / ; Deidre Wentworth / ; Susan Croopnick / ; Laura Newman / ; Kathleen Cabe / ; Sandra Hanson / ; Amy Castle / ; Eric Nussbaum / ; Linda Kuno / ; Jennifer Mattson / ; Howard Yonas / ; Alice Brown / ; Marc Malkoff / ; Glen Graham / ; Elaine Stack / ; Lori Kirby / ; Fernando Diaz / ; Richard Fessler / ; Vickie Gordon / ; Bradley Jacobs / ; Christopher Ogilvy / ; Deidre Buckley / ; Jaime Mansala / ; Allegra Bruce / ; Ferndinando Buonanno / ; David Greer / ; Meaghan Whalen / ; Frederic Meyer / ; Nicole Fode-Thomas / ; Steve Thalacker / ; David Piepgras / ; Jimmy Fulgham / ; John Atkinson / ; Jose Biller / ; Linda Chadwick / ; Douglas Anderson / ; Michael Schneck / ; Rima Dafer / ; Sarkis Morales Vidal / ; Edward Duckworth / ; Warren Selman / ; Gerri Zalaski / ; Valerie Cwiklinski / ; Cathy Sila / ; Robert Tarr / ; Nicholas Bambakadis / ; Jose Suarez / ; Carmel Graffagnino / ; Joanna Stoner / ; Sarah Moore / ; Allan Friedman / ; Vani Chilikuri / ; Jessica Kesler / ; Clarence Watridge / ; Mistina Pannell / ; Grace Miller / ; Michael Jaciewicz / ; Lance Wright / ; David Newell / ; Beth Miller Kraybill / ; William Likosky / ; Brandi French / ; Jeannie Bush / ; Amanda Brown / ; Joanie Block / ; Bonnie Blanchard / ; Kyra Becker / ; Laligam Sekhar / ; David Newell / ; Patricia Tanzi / ; Dian Nuxoll / ; Heather Bybee / ; Steven Cramer / ; John Volpi / ; Marilyn Bautista / ; Jonathan Zhang / ; David Chiu / ; James Ling / ; Donald Bledsoe / ; Jose Tenorio / ; Saleem Abdulrauf / ; Mandy Kane / ; Catharine Richard / ; Margaret Swoboda / ; Salvador Cruz-Flores / ; Brent Ibata / ; Richard Fessler / ; Kathryn Telck / ; Vickie Gordon / ; Daniel Pieper / ; Bruce Silverman / ; Fernando Diaz / ; John Whapham / ; Sandra Hanson / ; Amy Castle / ; Eric Nussbaum / ; David Sherman / ; Anne Leonard / ; Laura Moreno / ; Silvina Tonarelli / ; Robert Hart / ; Merrill Carolin / ; Gustavo Roman / ; Jean-Louis Caron / ; Oscar Benevente / ; Dennis Vollmer / ; Allyn Sher / ; Stacey Jett / ; Gerry Neely / ; Roi Ann Wallis / ; Kim Panizzon / ; Eliott Licht / ; Eric Cheng / ; Robert Gardner / ; Janey McAdoo / ; Darlene Haupt / ; Kathleen Riggs-Ruupp / ; Mounzer Kassab / ; Susan Wehner / ; Arshad Majid / ; Andrew Slivka / ; Julie Agriesti / ; Michael Dobbs / ; Anna Fowler / ; L Creed Pettigrew / ; Anand Vaishnar / ; Stephen Ryan / ; Sherry Williams / ; Fenwick Nichols / ; Brian Close / ; Askiel Bruno / ; Jeffrey Switzer / ; David Hess / ; Christiana Hall / ; Joanne Rogalsky-Nacca / ; Susan Wilson / ; Natalie Aucutt-Walter / ; David Huang / ; Roxanne Poole / ; Matthew Ostrander / ; William Logan / ; Sally Schroer / ; Gary Friday / ; Joan Brown / ; Colin P Derdeyn / ; Lennis Lich / ; Sally Schwarz / ; Greg Gaehle / ; Joseph Mantil / ; Pamela Strohmeyer / ; Elaine Gagermeier / ; Steve Mattmuller / ; T K Narayanan / ; Binzhi Shi / ; Martin Satter / ; Gordon Simmons / ; Brad Christian / ; Max Carone / ; Tonya Perkins / ; Marilyn Brackney / ; James Mountz / ; Julie Price / ; Donald Sashin / ; Carolyn Meltzer / ; Chet Mathis / ; Elma Abella / ; Dan Cariddi / ; Bruce Finley / ; Peter Valk / ; Jan Cronin / ; Ruth Tesar / ; Richard Hichwa / ; John Sunderland / ; Len Watkins / ; Laurie Ponto / ; Ronald Van Heertum / ; Norman Simpson / ; Chitra Saxena / ; Alan Lockwood / ; Michael Haka / ; Harry Chugani / ; Lynda Ferguson / ; Otto Musik / ; Tom Manger / ; Eric Reiman / ; Debbie Intorcia / ; Stephanie Reeder / ; Dan Bandy / ; Tricia Giurlani / ; Anita Prouty / ; Christine Burns / ; Charles Stone / ; Brad Christian / ; Alex Converse / ; Andrew Roberts / ; Terry Oakes / ; Kevin Dabbs / ; Brian Mullan / ; Mark Jacobson / ; Brad Kemp / ; Terry Brinkman / ; Pradeep Garg / ; Kathryn Morton / ; Paul Stroud / ; Kerry Link / ; Clive Brown-Proctor / ; Fred Fahey / ; Scott Wollenweber / ; Holly Smith / ; Peter Fox / ; Jean Hardies / ; Laura Morena / ; Shalaini Narayana / ; Paul Jerabek / ; John Mazziotta / ; Roger Woods / ; Olga Fernandez / ; Nazim Jaffer / ; Tom Brady / ; Alan Fischman / ; Ron Callahan / ; Jack Correi / ; Mark Goodman / ; Ron Crowe / ; John Votaw / ; J Douglas Bremner / ; Jonathan Nye / ; Janet Eary / ; Kenneth Krohn / ; Kristin Kauno / ; Barbara Lewellen / ; Linda Kimura / ; Steve Shoner / ; Tom Lewellen / ; R Edward Coleman / ; Neil Petry /
Comments/Corrections
Comment In:
Arch Neurol. 2012 Apr;69(4):518-20   [PMID:  22491197 ]
JAMA. 2011 Nov 9;306(18):2026-8   [PMID:  22068997 ]
Erratum In:
JAMA. 2011 Dec 28;306(24):2672
Note: Obviagele, Bruce [corrected to Ovbiagele, Bruce]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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