TY - JOUR
T1 - Cervical Arterial Dissection
T2 - Time for a Therapeutic Trial?
AU - Beletsky, Vadim
AU - Nadareishvili, Zurab
AU - Lynch, John
AU - Shuaib, Ashfaq
AU - Woolfenden, Andrew
AU - Norris, John W.
N1 - Funding Information:
I am grateful to Dr. Ru Chih Huang, in whose laboratory this project was originally developed, for guidance and for many helpful suggestions and to Dr. Edwin Murphy, who collaborated in developing this system. I also thank Dr. Mitchell Smith for communicating results prior to publication. This work was supported by a USPHS grant AG-00413-02 and Career Development Award I KO4 CA00178-01 from the National Institute of Health.
PY - 2003/12
Y1 - 2003/12
N2 - Background and Purpose-Cervical arterial dissection is a major cause of stroke in young adults, yet despite standard treatment with anticoagulants or antiplatelet drugs, its management remains uncertain. The goal of this study was to assess the natural history of the disorder and to decide on the feasibility of a therapeutic trial. Methods-Collaborating members of the Canadian Stroke Consortium prospectively enrolled consecutively referred patients with angiographically proven acute vertebral or carotid arterial dissection. Data recorded included clinical and radiological details, recurrence of ischemic cerebral events, and medical or surgical treatment. Results-Of 116 patients, 67 had vertebral and 49 had carotid dissections, with no difference in age or sex. In 68 (59%), trauma occurred at the time of dissection. During the course of a 1-year follow-up, at least 17 patients (15%) had recurrent transient ischemic attacks, stroke, or death, mainly in the weeks immediately after the dissection. In 105 patients with complete follow-up, the event rate in those treated with anticoagulants was 8.3% and in those treated with aspirin was 12.4%, a nonsignificant difference of 4.1%. Using these data, we calculate that for a 2-arm trial (aspirin versus anticoagulants) with 80% power and 5% significance, 913 patients are needed in each group. Conclusions-From our data indicating an initial relatively high recurrence rate, a multicenter trial of anticoagulants versus aspirin involving a total of 2000 patients is feasible.
AB - Background and Purpose-Cervical arterial dissection is a major cause of stroke in young adults, yet despite standard treatment with anticoagulants or antiplatelet drugs, its management remains uncertain. The goal of this study was to assess the natural history of the disorder and to decide on the feasibility of a therapeutic trial. Methods-Collaborating members of the Canadian Stroke Consortium prospectively enrolled consecutively referred patients with angiographically proven acute vertebral or carotid arterial dissection. Data recorded included clinical and radiological details, recurrence of ischemic cerebral events, and medical or surgical treatment. Results-Of 116 patients, 67 had vertebral and 49 had carotid dissections, with no difference in age or sex. In 68 (59%), trauma occurred at the time of dissection. During the course of a 1-year follow-up, at least 17 patients (15%) had recurrent transient ischemic attacks, stroke, or death, mainly in the weeks immediately after the dissection. In 105 patients with complete follow-up, the event rate in those treated with anticoagulants was 8.3% and in those treated with aspirin was 12.4%, a nonsignificant difference of 4.1%. Using these data, we calculate that for a 2-arm trial (aspirin versus anticoagulants) with 80% power and 5% significance, 913 patients are needed in each group. Conclusions-From our data indicating an initial relatively high recurrence rate, a multicenter trial of anticoagulants versus aspirin involving a total of 2000 patients is feasible.
KW - Issection
KW - Randomized controlled trials
KW - Stroke
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U2 - 10.1161/01.STR.0000098649.39767.BC
DO - 10.1161/01.STR.0000098649.39767.BC
M3 - Article
C2 - 14605328
AN - SCOPUS:0345599243
SN - 0039-2499
VL - 34
SP - 2856
EP - 2860
JO - Stroke
JF - Stroke
IS - 12
ER -