Purpose: To evaluate the feasibility and preliminary results of using paclitaxel-eluting stents for angioplasty and to treat symptomatic atherosclerotic ostial vertebral artery (VA) stenosis.
Materials and methods: Institutional review board approval and written informed consent were obtained for this prospective study. Nine men and one woman (average age, 65.9 years +/- 11.6 [standard deviation]) were included. Inclusion criteria were as follows: (a) Patients had angiographic evidence of VA ostial stenosis of 50% or more or stenosis of more than 45% if the contralateral VA was occluded. (b) Refractory vertebrobasilar ischemia, such as a stroke or transient ischemic attack, occurred while patients were taking one antiplatelet medication with optimal cardiovascular risk factor control. (c) Patients did not have another substantial vertebrobasilar stenotic lesion in the same territory. The primary end point was procedure safety, defined as mortality and permanent neurologic morbidity 30 days after stent placement. The secondary end point was clinical effectiveness, defined as recurrent vertebrobasilar ischemic symptoms within 12 months after stent placement and restenosis greater than or equal to 50% of the treated VA segment within 12 months after stent placement.
Results: The degree of stenosis ranged from 46% to 83% (mean, 67.3% +/- 11.9). The technical success rate was 100%. Procedure-related complication rate, mortality rate, and permanent neurologic morbidity rate at 30-day follow-up were 0%. At 12-month follow-up, no patient reported recurrent vertebrobasilar ischemic symptoms or had VA restenosis.
Conclusion: This pilot study suggests that use of paclitaxel-eluting stents in angioplasty and to treat symptomatic atherosclerotic ostial VA stenosis are feasible and promising in terms of potential safety and effectiveness in prevention of recurrent ischemia and restenosis. These results could be helpful in the formulation of a larger prospective randomized controlled trial.