The antiplatelet drug cilostazol (which prevents the blood from clotting) works as well as, and might be better than, aspirin in helping to prevent a secondary stroke in Asian patients, but with significantly less major bleeding. These results add to the evidence supporting cilostazol as a treatment option for patients with ischaemic stroke, particularly for patients at increased risk of bleeding, concludes an Article published Online First and in the October edition of The Lancet Neurology.
Previous research has shown that antiplatelet therapy is associated with a 25% reduction in recurrent ischaemic stroke. Aspirin is the most commonly prescribed antiplatelet medication to prevent recurrent stroke, but several other antiplatelet drugs have been assessed in the hope of improving on the effectiveness and safety of aspirin.
The second Cilostazol Stroke Prevention Study (CSPS 2) was designed to examine whether cilostazol was non-inferior to aspirin (at least as good as aspirin) in the prevention of stroke and to assess the efficacy and safety of cilostazol compared with aspirin in non-cardioembolic ischaemic stroke.
2757 patients with cerebral infarction* were enrolled from 278 sites across Japan and randomly assigned to either 100 mg of cilostazol twice daily (1379) or 81 mg of aspirin daily (1378) for a minimum of 1 year and a maximum of 5 years.
Over a mean follow-up of 29 months, the yearly rate of stroke (cerebral infarction, cerebral haemorrhage, or subarachnoid haemorrhage) was lower in the cilostazol group (2•76%) than in the aspirin group (3•71%)—significantly reducing the risk of stroke by 26% compared with aspirin.
Interestingly, severe bleeding events occurred in significantly fewer patients taking cilostazol (0•77% per year) than patients taking aspirin (1•78% per year), and cilostazol reduced the risk of major bleeding by 54%. However, other non-serious side-effects including headache, diarrhoea, palpitation, and dizziness, were significantly more common in the cilostazol group.
The authors conclude: "Cilostazol seems to be non-inferior, and might be superior, to aspirin for prevention of stroke after an ischaemic stroke, and was associated with fewer haemorrhagic events. Therefore, cilostazol could be used for prevention of stroke in patients with non-cardioembolic stroke"
In a Comment, Deepak Bhatt and Dharam Kumbhani from VA Boston Healthcare System, Brigham and Women's Hospital and Harvard Medical School, Boston, USA, caution that the results might not be generalisable because the study included only east Asian patients and only patients with non-severe strokes.
However, they conclude: "The results of the CSPS 2 trial are interesting and deserve validation in larger and more diverse study populations. The choice of the best antiplatelet drug for the secondary prevention of ischaemic stroke remains challenging, but the CSPS 2 trial shows that there might be another promising pathway for the secondary stroke prevention beyond the protection provided by aspirin."
Professor Yukito Shinohara, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital, Tokyo, Japan.
T) +81 42 523 3131 E) yshinoha@tachikawa-hosp.gr.jp
Professor Deepak Bhatt, VA Boston Healthcare System, Brigham and Women's Hospital and Harvard Medical School, Boston, USA.
T) +1 857 203 6840 E) DLBHATTMD@post.harvard.edu
For full Article and Comment see: http://press.thelancet.com/tlncilostazol.pdf
Notes to Editors: *Cerebral infarction is an ischaemic type of stroke caused by a blood clot preventing blood flow in the blood vessels supplying the brain.
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Journal
The Lancet Neurology