Percutaneous transluminal balloon angioplasty (PTBA) aimed at reducing cerebral vasospasm does not improve the poor outcomes of patients with Fisher grade III subarachnoid hemorrhage (SAH), according to a report in the June issue of Stroke.
"PTBA is not effective and other less invasive treatments should be investigated," Dr. Marike Zwienenberg-Lee from the University of California, Davis Medical Center, Sacramento, told Reuters Health.
Dr. Zwienenberg-Lee and colleagues in The Balloon Prophylaxis for Aneurysmal Vasospasm (BPAV) Study Group evaluated the efficacy of prophylactic PTBA in a phase II study of 170 patients with SAH. The mean time to PTBA after SAH was 51 hours.
The incidence of vasospasm did not differ significantly between the group that received PTBA and the group that did not, the authors report, though fewer patients in the PTBA group developed a delayed ischemic neurological deficit.
Significantly fewer patients in the PTBA group (12 per cent) than in the control group (26 per cent) required endovascular treatment for medically refractory vasospasm, the report indicates, but PTBA resulted in an insignificant trend toward a reduced risk of an unfavorable outcome.
Four patients developed a procedure-related complication, and three died as a result of these complications.
"Although the trial was unsuccessful as defined by the primary end point," the authors conclude, "the findings are at least somewhat encouraging in that there seems to be proof of concept, with a statistically significantly decreased need for therapeutic angioplasty in the patients who received PTBA."
"However, it does not appear that PTBA makes a significant impact on clinical course, and as such, as well as because of the difficulties in accruing patients in this trial, we do not recommend further study of PTBA," the investigators conclude.
"We of course hoped to find a treatment effect with our treatment, but it is not uncommon in clinical medicine that a very promising treatment in an institutional series does not result in a measurable effect once randomization and blinding are applied," Dr. Zwienenberg-Lee said. "The research into endothelins and their role in vasospasm should be pursued."
