Martin J O'Donnell1, John W Eikelboom2, Salim Yusuf2, Hans-Christoph Diener3, Robert G Hart2, Eric E Smith4, David J Gladstone5, Mukul Sharma6, Rafael Dias7, Greg Flaker8, Alvaro Avezum9, Jun Zhu10, Gayle Lewis2, Stuart Connolly2. 1. Population Health Research Institute, McMaster University, and Hamilton Health Sciences, Hamilton, ON, Canada; HRB-Clinical Research Facility, NUI Galway, Galway, Ireland. Electronic address: odonnm@mcmaster.ca. 2. Population Health Research Institute, McMaster University, and Hamilton Health Sciences, Hamilton, ON, Canada. 3. Department of Neurology, University Hospital, Essen, Germany. 4. Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada. 5. Department of Neurology, University of Toronto, Toronto, ON, Canada. 6. Department of Medicine, McMaster University, Hamilton, ON, Canada. 7. Estudios Clinicos Latinoamerica, Rosario, Argentina. 8. University of Missouri, Colombia, MO. 9. Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil. 10. Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Abstract
BACKGROUND: Clinical and subclinical (covert) stroke is a cause of cognitive loss and functional impairment. In the AVERROES trial, we performed serial brain magnetic resonance imaging (MRI) scans in a subgroup to explore the effect of apixaban, compared with aspirin, on clinical and covert brain infarction and on microbleeds in patients with atrial fibrillation. METHODS: We performed brain MRI (T1, T2, fluid-attenuated inversion recovery, and T2* gradient echo sequences) in 1,180 at baseline and in 931 participants at follow-up. Mean interval from baseline to follow-up MRI scans was 1.0 year. The primary outcome was a composite of clinical ischemic stroke and covert embolic pattern infarction (defined as infarction >1.5 cm, cortical-based infarction, or new multiterritory infarction). Secondary outcomes included new MRI-detected brain infarcts and microbleeds and change in white matter hyperintensities. RESULTS:Baseline MRI scans revealed brain infarct(s) in 26.2% and microbleed(s) in 10.5%. The rate of the primary outcomes was 2.0% in the apixaban group and 3.3% in the aspirin group (hazard ratio [HR] 0.55; 0.27-1.14) from baseline to follow-up MRI scan (mean duration of follow-up: 1 year). In those who completed baseline and follow-up MRI scans, the rate of new infarction detected on MRI was 2.5% in the apixaban group and 2.2% in the aspirin group (HR 1.09; 0.47-2.52), but new infarcts were smaller in the apixaban group (P = .03). There was no difference in proportion with new microbleeds on follow-up MRI (HR 0.92; 0.53-1.60) between treatment groups. CONCLUSIONS:Apixaban treatment was associated with a nonsignificant trend toward reduction in the composite of clinical ischemic stroke and covert embolic-pattern infarction and did not increase the number of microbleeds in patients with atrial fibrillation compared with aspirin.
RCT Entities:
BACKGROUND: Clinical and subclinical (covert) stroke is a cause of cognitive loss and functional impairment. In the AVERROES trial, we performed serial brain magnetic resonance imaging (MRI) scans in a subgroup to explore the effect of apixaban, compared with aspirin, on clinical and covert brain infarction and on microbleeds in patients with atrial fibrillation. METHODS: We performed brain MRI (T1, T2, fluid-attenuated inversion recovery, and T2* gradient echo sequences) in 1,180 at baseline and in 931 participants at follow-up. Mean interval from baseline to follow-up MRI scans was 1.0 year. The primary outcome was a composite of clinical ischemic stroke and covert embolic pattern infarction (defined as infarction >1.5 cm, cortical-based infarction, or new multiterritory infarction). Secondary outcomes included new MRI-detected brain infarcts and microbleeds and change in white matter hyperintensities. RESULTS: Baseline MRI scans revealed brain infarct(s) in 26.2% and microbleed(s) in 10.5%. The rate of the primary outcomes was 2.0% in the apixaban group and 3.3% in the aspirin group (hazard ratio [HR] 0.55; 0.27-1.14) from baseline to follow-up MRI scan (mean duration of follow-up: 1 year). In those who completed baseline and follow-up MRI scans, the rate of new infarction detected on MRI was 2.5% in the apixaban group and 2.2% in the aspirin group (HR 1.09; 0.47-2.52), but new infarcts were smaller in the apixaban group (P = .03). There was no difference in proportion with new microbleeds on follow-up MRI (HR 0.92; 0.53-1.60) between treatment groups. CONCLUSIONS:Apixaban treatment was associated with a nonsignificant trend toward reduction in the composite of clinical ischemic stroke and covert embolic-pattern infarction and did not increase the number of microbleeds in patients with atrial fibrillation compared with aspirin.
Authors: Joseph Kwan; Melanie Hafdi; Lorraine L W Chiang; Phyo K Myint; Li Siang Wong; Terry J Quinn Journal: Cochrane Database Syst Rev Date: 2022-07-14
Authors: Meredith P Murphy; Joji B Kuramatsu; Audrey Leasure; Guido J Falcone; Hooman Kamel; Lauren H Sansing; Christina Kourkoulis; Kristin Schwab; Jordan J Elm; M Edip Gurol; Huy Tran; Steven M Greenberg; Anand Viswanathan; Christopher D Anderson; Stefan Schwab; Jonathan Rosand; Fu-Dong Shi; Steven J Kittner; Fernando D Testai; Daniel Woo; Carl D Langefeld; Michael L James; Sebastian Koch; Hagen B Huttner; Alessandro Biffi; Kevin N Sheth Journal: Stroke Date: 2018-11 Impact factor: 7.914
Authors: Gargi Banerjee; Roxana Carare; Charlotte Cordonnier; Steven M Greenberg; Julie A Schneider; Eric E Smith; Mark van Buchem; Jeroen van der Grond; Marcel M Verbeek; David J Werring Journal: J Neurol Neurosurg Psychiatry Date: 2017-08-26 Impact factor: 10.154