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document
Effect of prophylactic transluminal balloon angioplasty on cerebral vasospasm and outcome in patients with Fisher grade III subarachnoid hemorrhage : results of a phase II multicenter , randomized , clinical trial . BACKGROUND AND PURPOSE Cerebral vasospasm continues to be a major cause of poor outcome in patients with ruptured aneurysms . Prophylactic Transluminal Balloon Angioplasty ( pTBA ) appeared to prevent delayed ischemic neurological deficit in a pilot study . A phase II multicenter randomized clinical trial was subsequently designed . METHODS One hundred and seventy patients with Fisher Grade III subarachnoid hemorrhage were enrolled in the study . Of these , 85 patients were randomized to the treatment group and underwent pTBA within 96 hours after subarachnoid hemorrhage . Main end points of the study included the 3-month dichotomized Glasgow Outcome Score ( GOS ) , development of delayed ischemic neurological deficit ( DIND ) , occurrence of Transcranial Doppler ( TCD ) vasospasm , and length of stay in the ICU and hospital . RESULTS The incidence of DIND was lower in the pTBA group ( P=0.30 ) and fewer patients required therapeutic angioplasty to treat DIND ( P=0.03 ) . Overall pTBA resulted in an absolute risk reduction of 5.9 % and a relative risk reduction of 10.4 % unfavorable outcome ( P=0.54 ) . Good grade patients had absolute and relative risk reductions of respectively 9.5 and 29.4 % ( P=0.73 ) . Length of stay in ICU and hospital was similar in both groups . Four patients had a procedure-related vessel perforation , of which three patients died . CONCLUSIONS While the trial is unsuccessful as defined by the primary end point ( GOS ) , proof of concept is confirmed by these results . Fewer patients tend to develop vasospasm after treatment with pTBA and there is a statistically significantly decreased need for therapeutic angioplasty . pTBA does not improve the poor outcome of patients with Fisher grade III subarachnoid hemorrhage .
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Intervention_Physical
prophylactic transluminal balloon angioplasty
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Intervention_Physical
Prophylactic Transluminal Balloon Angioplasty ( pTBA )
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Intervention_Surgical
pTBA
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Intervention_Physical
angioplasty
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Outcome_Physical
cerebral vasospasm
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Outcome_Mental
3-month dichotomized Glasgow Outcome Score ( GOS )
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Outcome_Mental
development of delayed ischemic neurological deficit ( DIND )
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Outcome_Physical
occurrence of Transcranial Doppler ( TCD ) vasospasm
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Outcome_Other
length of stay in the ICU
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Outcome_Mental
incidence of DIND
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Outcome_Other
pTBA
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Outcome_Other
Length of stay in ICU
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Outcome_Physical
procedure-related vessel perforation
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Outcome_Physical
vasospasm
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Outcome_Other
need for therapeutic angioplasty
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Participant_Condition
Fisher grade III subarachnoid hemorrhage :
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Participant_Sample-size
One hundred and seventy patients
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Participant_Condition
Fisher Grade III subarachnoid hemorrhage
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Participant_Condition
Fisher grade III subarachnoid hemorrhage