Individual patient data meta-analysis of antiplatelet regimens after noncardioembolic stroke or TIA: rationale and design.
BACKGROUND
The Cerebrovascular Antiplatelet Trialists' Collaborative Group was formed to obtain and analyze individual patient data from the major randomized trials of common antiplatelet regimens after cerebral ischemia. Although the risk of stroke can be reduced by antiplatelet drugs, there continues to be uncertainty about the balance of risk and benefits of different antiplatelet regimens for an individual patient.


OBJECTIVE
Our aim is to provide clinicians with a thorough evidence-based answer on these therapeutic alternatives.


METHODS
We have identified six large randomized trials and plan to meta-analyze the data on an individual patient level. In total, these trials have enrolled 46 948 patients with cerebral ischemia. Uniquely, the Cerebrovascular Antiplatelet Trialists' Collaborative Group has secured access to the individual data of all of these trials, with the participation of key investigators and pharmaceutical companies. Our principal objective includes deriving a reliable estimate of the efficacy of different antiplatelet regimens on key outcomes including serious vascular events, major ischemic events, major bleeding, and intracranial hemorrhage.


RESULTS
We propose to redefine composite outcome events, if necessary, to achieve comparability. Further, we aim to build and validate prognostic models for the risk of major bleeding and intracranial hemorrhage and to build a decision model that may support evidence-based decision making about which antiplatelet regimen would be most effective in different risk groups of patients.


CONCLUSIONS
This paper outlines inclusion criteria, outcome measures, baseline characteristics, and planned statistical analysis.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.|Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Jacoba P
JP
Greving
Department of Neurology, University Hospital Essen, Essen, Germany.
Hans-Christoph
HC
Diener
Department of Neurology, University of Debrecen Medical and Health Science Center, Debrecen, Hungary.
László
L
Csiba
Department of Neurology, University of Heidelberg, Heidelberg, Germany.
Werner
W
Hacke
Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
L Jaap
LJ
Kappelle
Department of Neurology, Erasmus Medical Center, Rotterdam, The Netherlands.
Peter J
PJ
Koudstaal
Department of Neurology, Roger Salengro Hospital, Lille, France.
Didier
D
Leys
Department of Neurology, Hôpital Sainte-Anne, Université Paris Descartes, Paris, France.
Jean-Louis
JL
Mas
Department of Neurology, Miller School of Medicine, University of Miami, Coral Gables, FL, USA.
Ralph L
RL
Sacco
Department of Neurology, University Hospital of Kuopio and University of Eastern Finland, Kuopio, Finland.
Juhani
J
Sivenius
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.|Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Ale
A
Algra
D005260:Female; D006801:Humans; D002546:Ischemic Attack, Transient / Q000188:drug therapy*; D008297:Male; D017063:Outcome Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D055502:Secondary Prevention; D020521:Stroke / Q000188:drug therapy*
D010975:Platelet Aggregation Inhibitors
antiplatelet therapy; aspirin; epidemiology; intracerebral hemorrhage; protocols; vascular events