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

Marike Zwienenberg-Lee, Jonathan Hartman, Nancy Rudisill, Lori Kennedy Madden, Karen Smith, Joseph Eskridge, David Newell, Bon Verweij, M. Ross Bullock, Andrew Baker, William Coplin, Robert Mericle, Jian Dai, David M Rocke, Jan Paul Muizelaar

Research output: Contribution to journalArticle

106 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1759-1765
Number of pages7
JournalStroke
Volume39
Issue number6
DOIs
StatePublished - Jun 1 2008

Fingerprint

Intracranial Vasospasm
Balloon Angioplasty
Subarachnoid Hemorrhage
Angioplasty
Randomized Controlled Trials
Numbers Needed To Treat
Length of Stay
Ruptured Aneurysm
Risk Reduction Behavior
Therapeutics

Keywords

  • Aneurysm
  • Angioplasty
  • Outcome
  • Randomized clinical trials
  • Stenting
  • Subarachnoid hemorrhage
  • Vasospasm

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Clinical Neurology
  • Advanced and Specialized Nursing
  • Medicine(all)

Cite this

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. / Zwienenberg-Lee, Marike; Hartman, Jonathan; Rudisill, Nancy; Madden, Lori Kennedy; Smith, Karen; Eskridge, Joseph; Newell, David; Verweij, Bon; Bullock, M. Ross; Baker, Andrew; Coplin, William; Mericle, Robert; Dai, Jian; Rocke, David M; Muizelaar, Jan Paul.

In: Stroke, Vol. 39, No. 6, 01.06.2008, p. 1759-1765.

Research output: Contribution to journalArticle

Zwienenberg-Lee, Marike ; Hartman, Jonathan ; Rudisill, Nancy ; Madden, Lori Kennedy ; Smith, Karen ; Eskridge, Joseph ; Newell, David ; Verweij, Bon ; Bullock, M. Ross ; Baker, Andrew ; Coplin, William ; Mericle, Robert ; Dai, Jian ; Rocke, David M ; Muizelaar, Jan Paul. / 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. In: Stroke. 2008 ; Vol. 39, No. 6. pp. 1759-1765.
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abstract = "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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T1 - Effect of prophylactic transluminal balloon angioplasty on cerebral vasospasm and outcome in patients with fisher grade IIi subarachnoid hemorrhage

T2 - Results of a phase II multicenter, randomized, clinical trial

AU - Zwienenberg-Lee, Marike

AU - Hartman, Jonathan

AU - Rudisill, Nancy

AU - Madden, Lori Kennedy

AU - Smith, Karen

AU - Eskridge, Joseph

AU - Newell, David

AU - Verweij, Bon

AU - Bullock, M. Ross

AU - Baker, Andrew

AU - Coplin, William

AU - Mericle, Robert

AU - Dai, Jian

AU - Rocke, David M

AU - Muizelaar, Jan Paul

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N2 - 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.

AB - 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.

KW - Aneurysm

KW - Angioplasty

KW - Outcome

KW - Randomized clinical trials

KW - Stenting

KW - Subarachnoid hemorrhage

KW - Vasospasm

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