Stenting versus aggressive medical therapy in the treatment of intracranial arterial stenosis

This trial examined whether stenting of intracranial arterial stenosis reduces the risk of additional strokes compared to medical therapy alone. 

Intracranial arterial stenosis (narrowing of the arteries supplying blood to the brain) is an important cause of stroke. The main cause of arterial stenosis is the process of atherosclerosis (the accumulation of cholesterol in the walls of the arteries). These fatty plaques may easily rupture, leading to the formation of a clot which may block the artery.

Two strategies are currently used to protect patients with intracranial arterial stenosis from additional strokes. Medical therapy with drugs that prevent clot formation (anti-platelet drugs), and drugs that reduce risk factors, such as high cholesterol and high blood sugar levels, as well as high blood pressure, have been the standard of care for many years. A new treatment strategy recently employed is percutaneous transluminal angioplasty and stenting (PTAS). PTAS is not a surgical procedure, but rather preformed by inserting a small wire (catheter) into the affected artery (a procedure called catheterization). A stent (a wire mesh tube that holds the artery open) is then placed within the blocked artery, restoring normal blood flow to the brain.

451 patients who had recently suffered a stroke or a transient ischemic attack (TIA; a temporary stroke that does not result in any lasting symptoms) due to intracranial arterial stenosis were included in this trial. Patients were randomly assigned to receive either aggressive medical management alone, or the same medical management and PTAS in order to reduce stroke recurrence rates. The rate of additional strokes and death was assessed after an initial 30-day period. Data concerning survival after 30-days was analyzed for up to one year after the trial, since patient follow up was still ongoing.

The 30-day rate of additional stroke was 14.7% in patients treated with PTAS, compared to 5.8% of patients treated with medications alone. Most of the additional strokes in patients treated with PTAS occurred in the first day following treatment, and all strokes occurred within 6 days of PTAS treatment. The 30-day death rate was 2.2% of patients treated with PTAS all due to a stroke, compared to 0.4% of patients (a single patient) treated with medication alone, due to other causes.

Beyond 30 days, the risk of additional strokes and death also differed between groups. The 1-year rate of additional strokes or death was 20.0% of patients treated with PTAS, compared to 12.2% of patients treated with medication alone.

This trial concluded that aggressive medical therapy with drugs was better than PTAS in the treatment of patients with intracranial arterial stenosis.

Recruitment of patients to this trial was halted after 451 patients due to the high rate of early strokes and death after PTAS treatment compared to the medical treatment group.

Consult with your physician regarding the optimal medications used to reduce the risk of additional strokes.