Effect of a Balloon-Expandable Intracranial Stent vs Medical Therapy on Risk of Stroke in Patients With Symptomatic Intracranial Stenosis-The VISSIT Randomized Clinical Trial

May Le, Mercer University College of Pharmacy 2015

The most common cause of stroke is atherosclerotic stenosis of the intracranial arteries.  According to Turan et al., those with symptomatic intracranial stenosis have a high risk of recurrent stroke, especially if the stenosis is greater than 70%.  Medications for hypertension and hyperlipidemia are considered important in reducing this high risk per Turan et al.  Stroke prevention therapies include aspirin, clopidogrel, angioplasty and stenting.1

A recent published study compared the use of balloon expandable stent versus medical therapy in patients with symptomatic intracranial stenosis.2

Title:  Effect of a Balloon-Expandable Intracranial Stent vs Medical Therapy on Risk of Stroke in Patients With Symptomatic Intracranial Stenosis-The VISSIT Randomized Clinical Trial
Design Multicenter, international, randomized, parallel group; 112 participants
Objective To compare the efficacy and safety of the balloon-expandable stent plus medical therapy versus medical therapy alone in intracranial stenosis
Study Groups Medical therapy alone (medical group; n= 53)

Balloon-expandable stent plus medical therapy (stent group; n= 59)

Methods Medical group: clopidogrel 75 mg daily for three months and aspirin 81 to 325 mg daily during study period

Stent group: underwent procedure within 48 hours of randomization

Duration From January 2009 to June 2012, last follow-up May 2013
Primary Outcome Measure Composite of stroke in the same territory within twelve months of randomization or hard transient ischemic attack (TIA) in the same territory day two through month twelve post randomization
Baseline Characteristics Medical group: mean age 61.8, male 32, white 38, Asian 7, black 5, Hispanic 2, hypertension 43, hyperlipidemia 32, diabetes 20, current smoker 12, coronary artery disease (CAD) 12, peripheral vascular disease (PVD) 5, mean body mass index (BMI) 28.8

Stent group: mean age 61.8, male 41, white 42, Asian 7, black 4, Hispanic 5, hypertension 49, hyperlipidemia 29, diabetes 25, current smoker 11, CAD 10, PVD 2, mean BMI 28.9

Results Stroke or hard TIA in the medical group: 8/53, 15.1%, 95% confidence interval (CI), 6.7-27.6, p= 0.02

Stroke or hard TIA in the stent group: 21/58, 36.2%, 95% CI, 24.0-49.9, p= 0.02

Adverse Events Common Adverse Events: not reported
Serious Adverse Events:

Stroke within 30 days of randomization: medical group 5.7%, stent group 17.2%

Hard TIA between day two and day thirty: medical group 3.8%, stent group 0%

Mortality within 30 days post procedure: medical group 0%, stent group 5.2%

Intracranial hemorrhage within 30 days of randomization: medical group 0%, stent group 8.6%

Percentage that Discontinued due to Adverse Events: not reported
Study Author Conclusions Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA. These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis.

This study suggests that medical therapy of aspirin and clopidogrel is superior to balloon-expandable stent in preventing recurrent stroke or TIA within one year post symptomatic intracranial stenosis.  Stenting was shown to cause more adverse events than medical therapy.  However, this study only looked at one year post stroke so there is no evaluation of long term outcomes for secondary stroke prevention.

References:

  1. Turan TN, Derdeyn CP, Fiorella D, Chimowitz MI. Treatment of atherosclerotic intracranial arterial stenosis. Stroke. 2009;40(6):2257-61.
  2. Zaidat OO, Fitzsimmons BF, Woodward BK, et al. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015;313(12):1240-8.
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