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Are the efficacy and safety of clopidogrel plus aspirin vs aspirin alone consistent in different infarction patterns after transient ischemic attack or minor stroke?
In the imaging substudy of the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events randomized clinical trial that included 1089 transient ischemic attacks and minor strokes, a significant risk reduction of 50% in stroke recurrence was observed in patients with multiple acute infarctions administered clopidogrel plus aspirin compared with aspirin alone, and this finding was not observed in patients with a single acute infarction or no acute infarction. The bleeding risk was similar among treatment groups.
Patients with multiple acute infarctions received the most pronounced clinical benefit from dual antiplatelet therapy.
Infarction patterns may serve as important imaging markers to assess the probability of stroke recurrence in transient ischemic attack (TIA) and minor stroke. However, it is unclear whether patients with different infarction patterns benefit differently from dual antiplatelet therapy.
To investigate whether infarction patterns can stratify the risk of recurrent stroke and whether the efficacy and safety of clopidogrel plus aspirin vs aspirin alone are consistent in different infarction patterns after TIA or minor stroke.
Design, Setting, and Participants
In this prespecified imaging substudy of the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events (CHANCE) randomized clinical trial, a total of 1342 patients with noncardioembolic TIA or minor stroke at 45 sites of CHANCE from October 1, 2009, to July 30, 2012, were included in this substudy. The final analysis was conducted on July 30, 2016, and included 1089 patients with required magnetic resonance imaging sequences. Infarction patterns were grouped into multiple acute infarctions (MAIs), single acute infarction (SAI), and no acute infarction (NAI) according to diffusion-weighted imaging.
Main Outcomes and Measures
Primary and secondary efficacy outcomes were stroke recurrence and new clinical vascular event after 3 months, respectively. The safety outcome was moderate to severe bleeding risk after 3 months.
Among 1089 patients, the mean (SD) age was 63.1 (10.7) years and 731 patients (65%) were men. Patients with MAIs (hazard ratio [HR], 5.8; 95% CI, 2.2-15.1; P < .001) and SAI (HR, 3.9; 95% CI, 1.5-10.5; P = .007) had higher risk of recurrent stroke than those with NAI after adjustment for potential confounders at 3-month follow-up. Stroke recurrence occurred in 15 (10.1%) and 25 (18.8%) of patients with MAIs administered clopidogrel plus aspirin and placebo plus aspirin, respectively (HR, 0.5; 95% CI, 0.3-0.96; P = .04), 24 (8.9%) and 24 (8.5%) of patients with SAI administered clopidogrel plus aspirin and placebo plus aspirin, respectively (HR, 1.1; 95% CI, 0.6-2.0; P = .71), and 3 (2.6%) and 2 (1.4%) of patients with NAI administered clopidogrel plus aspirin and placebo plus aspirin, respectively (HR, 1.7; 95% CI, 0.3-11.1; P = .56), with P = .04 for treatment × infarction pattern interaction effect. Clopidogrel plus aspirin did not increase moderate to severe bleeding risk.
Conclusions and Relevance
Infarction patterns can efficiently stratify the risk of recurrent stroke within 3 months of noncardioembolic TIA or minor ischemic stroke. Patients with MAIs received the most pronounced clinical benefit from dual antiplatelet therapy without increasing the risk of moderate to severe bleeding. However, even if after dual antiplatelet treatment, patients with MAIs still had a risk of stroke recurrence as high as those with SAI.
clinicaltrials.gov Identifier: NCT00979589
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Accepted for Publication: December 21, 2017.
Corresponding Author: Yilong Wang, MD, PhD, No. 6 Tiantanxili, Dongcheng District, Beijing, China, 100050 (email@example.com).
Published Online: March 26, 2018. doi:10.1001/jamaneurol.2018.0247
Author Contributions: Dr Yilong Wang had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Jing, Zhao, Liu, Li, Johnston, Yongjun Wang, Yilong Wang.
Acquisition, analysis, or interpretation of data: Jing, Meng, Zhao, A. Wang, Pan, D. Wang, Yilong Wang.
Drafting of the manuscript: Jing, Meng, Liu.
Critical revision of the manuscript for important intellectual content: Meng, Zhao, A. Wang, Pan, Li, D. Wang, Johnston, Yongjun Wang, Yilong Wang.
Statistical analysis: Jing, A. Wang, Pan, Li.
Obtained funding: Meng, Zhao, Yongjun Wang, Yilong Wang.
Administrative, technical, or material support: Jing, D. Wang, Yilong Wang.
Study supervision: Zhao, Liu, Johnston, Yongjun Wang.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported by grants 2015BAI12B04, 2015BAI12B02, 2016YFC0901000, 2016YFC0901001, and 2016YFC0901002 from the Ministry of Science and Technology of the People’s Republic of China; grants D151100002015001, D151100002015002, D151100002015003, Z15110200390000, and Z151100003915117 from the Beijing Municipal Science and Technology Commission; and grants No.2016-1-2041 and SML20150502 from the Beijing Municipal Commission of Health and Family Planning.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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