Study protocol

The TEAM trial : Safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: A randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years

Jean Raymond , Andrew J. Molyneux , Allan J. Fox , S. CLAIBORNE Johnston , Jean-Paul Collet and Isabelle Rouleau

Trials 2008, 9:43doi:10.1186/1745-6215-9-43

Published:	16 July 2008

Abstract (provisional)

The management of patients with unruptured aneurysms remains controversial. Patients with unruptured aneurysms may suffer intracranial haemorrhage, but the incidence of this event is still debated; endovascular treatment may prevent rupture, but involves immediate risks. Hence, the balance of risks and benefits of endovascular treatment is uncertain. Here, we report the design of the TEAM trial, the first international, randomized, controlled trial comparing conservative management with endovascular treatment. Primary endpoint is mortality and morbidity (modified Rankin Score 3) from intracranial haemorrhage or treatment. Secondary endpoints include incidence of hemorrhagic events, morbidity related to endovascular coiling, morphological results, overall clinical outcome and quality of life. Statistical tests compare between probabilities at 5- and 10-years of 1/ mortality from haemorrhage related to the lesion, excluding per-operative complications; 2/ mortality from haemorrhage or from complications of treatment; 3/combined disease or treatment related mortality and morbidity in the absence of other causes of death or disability. The study will be conducted in 60 international centres and will enrol 2,002 patients equally divided between the two groups, a size sufficient to achieve 80% power at a 0.0167 significance to detect differences in 1) disease or treatmentrelated poor outcomes from 7-9% to 3-5%; 2) overall mortality from 16 to 11%. Duration of the study is 14 years, the first three years being for patient recruitment plus a minimum of 10 years of follow-up. The TEAM trial thus offers a means to reconcile the introduction of a new approach with the necessity to acknowledge uncertainties. Trial registration : Current Controlled Trials ISRCTN62758344 (www.controlledtrials. com)