Recurrent symptomatic high-grade intracranial stenoses: safety and efficacy of undersized stents--initial experience.

PURPOSE

To prospectively evaluate the safety and efficacy of undersized stents used in patients with high-grade intracranial stenosis and recurrent ischemic symptoms who are undergoing medical treatment.

MATERIALS AND METHODS

In 18 patients (13 men, five women; age range, 51-82 years), 20 high-grade (>70%) intracranial stenoses were selected for stent placement. All patients had transient ischemic symptoms or minor strokes while undergoing combined antithrombotic therapy with acetylsalicylic acid plus clopidogrel or anticoagulation therapy with warfarin or heparin plus acetylsalicylic acid. Technical success was defined as reaching the target lesion and deploying a stent, with a residual stenosis of less than 50%. The diameter of the stent was 0.5-mm smaller than the measured diameter of the normal adjacent vessel to avoid dissection and vessel rupture. Primary endpoints for safety evaluation were the combined incidence of death or major or minor stroke at 30 days; for efficacy evaluation, the primary endpoint was the incidence of any stroke in the treated vascular territory within the first 6 months. Statistical evaluation of the reduction of stenosis was performed.

RESULTS

In 18 of 20 stenoses, a stent was placed and the degree of stenosis was reduced from a median of 82% (range, 72%-97%) to a median of 16% (5%-40%; P <.001). The technical success rate was 90%. One patient had a parenchymal hemorrhage in a preexisting infarct on the 2nd day. Thus, the 30-day combined stroke and death rate was 6%. No immediate complication, thromboembolism, dissection compromising blood flow, or vessel rupture occurred during these procedures. Within the first 6 months after intervention, no patient had new ischemic symptoms in the treated vascular territory.

CONCLUSION

In selected patients with recurrent ischemic events due to high-grade intracranial stenosis, undersized stent placement holds promise as an effective and safe procedure.