Disability due to recurrent stroke and cognitive decline in patients with ischaemic stroke were not different between two anticlotting (antiplatelet) regimens and were not affected by the preventive use of telmisartan. These are conclusions of an Article published early Online and in the October issue of Lancet Neurology, authored by Dr Hans-Christoph Diener, University Hospital Essen, Germany, and colleagues.
In this randomised-controlled trial, patients who had had a stroke were randomly assigned to received either 25 mg aspirin (ASA) plus 200 mg extended-release dipyridamole (ER-DP) twice a day or 75mg clopidogrel once a day; and 80 mg telmisartan once a day, or placebo*. A total of 20 332 patients, mean age 66 years, were followed up for a median of 2.4 years. Of thepatients who had a recurrent stroke 916 were assigned to ASA with ER-DP, 898 to clopidogrel, 880 to telmisartan, and 934 to placebo. The proportion of patients that had recurrent stroke was 9% in all four groups. Each patient's disability was assessed with three scores: the modified Rankin Scale (mRS) and the Barthel Index at three months, and cognitive decline assessed with the mini-mental state examination at four weeks after randomisation and at the penultimate visit. None of these measures revealed any significant differences between the four groups.
The authors conclude: "Disability due to recurrent stroke and cognitive decline in patients with ischaemic stroke were not different between the two antiplatelet regimens and were not affected by the preventive use of telmisartan…the most probable explanation is that neither ASA with ER-DP nor clopidogrel are neuroprotective, despite indications from experiments in animals that this may be the case." They add that telmisartan is also probably not neuroprotective.
In an accompanying Comment, Professor Graeme Hankey, Royal Perth Hospital, WA, Australia, and Dr John Eikelboom, McMaster University, Canada, say: "The PRoFESS trial investigators are to be congratulated for completing the largest trial of its kind in the world…Hopefully, future trials of such stature will address the remaining questions, such as: 'what are the optimum antiplatelet and antihypertensive regimens for acute (as opposed to subacute) TIA and ischaemic stroke?' and 'how can we accurately measure, and optimally minimise , the physical and cognitive sequelae of disabling stroke?'."
Notes to editors: *Group 1 received aspirin plus extended-release dipyridamole AND telmisartan; group 2 received aspirin plus extended-release dipyridamole AND placebo; group 3 received clopidogrel AND telmisartan; group 4 received clopidogrel AND placebo
Aspirin plus extended-release dipyridamole and clopidogrel are antiplatelet drugs and temisartan is a angiotensin II receptor antagonist; therefore, the trial design enables the authors to compare group 1 with group 2 and group 3 with group 4 to see if telmisartan, which lowers blood pressure, is neuroprotective against the background of two different antiplatelet regimens, which might or might not be neuroprotective.
Dr Hans-Christoph Diener, University Hospital Essen, Germany T) +49 201 723 2460 E) hans.diener@uni-duisburg-essen.de
Professor Graeme Hankey, Royal Perth Hospital, WA, Australia T) + 61 404 894 071 E) gjhankey@cyllene.uwa.edu.au
Full study and comment: http://press.thelancet.com/TLNPRoFESSfinal.pdf
Journal
The Lancet Neurology