Objective Recent studies have shown that intracranial stenting of ICAD is not superior to anti-platelet therapy alone for previously untreated patents. The question remains as to which therapy is superior in preventing ipsilateral stroke in patients who have failed antiplatelet therapy. At our institution, patients were referred for intracranial stenting only after having a hard TIA or stroke while on antiplatelet therapy. These patients were screened for enrollment into the VISSIT Trial. Thus, this single center experience offers a randomised subgroup of patients with intracranial stenosis whom have failed medical therapy.
Methods During the period of April 2009 to November 2011, patients referred for symptomatic intracranial stenosis were screened and enrolled in the VISSIT study at our institution. The inclusion criteria of intracranial stenosis >70% by maximal cross-sectional diameter were met in all 13 patients. All patients had a hard TIA or stroke in the same hemisphere within 30 days of enrollment. However, at our institution, an additional inclusion criterion was demanded: each patient must have been on antiplatelet therapy at the time of their qualifying event, and thus had failed medical therapy prior to enrollment. After randomization, standard medical therapy was ensured in both arms, with antiplatelet therapy, P2Y12 resistance testing, antihypertensive therapy, and statin therapy to lower baseline LDL-C levels. Clinical events were captured during the VISSIT Trial follow-up period, with the primary endpoint of hard TIA or stroke in the affected territory evaluated for each patient. The two arms were then compared for primary endpoint failures.
Results A total of 13 patients were randomised at our site in the VISSIT Trial. Of these patients, 6 were randomised to the stenting arm, and 7 to the medical arm. Of the patients who randomised to the stent arm, all had successful placement of the Pharos Vitesse stent. No neurologic clinical events were noted intra-operatively or at the time of discharge. 1 patient had a qualifying event, and with a hard TIA 6 weeks post stent placement, for a primary endpoint failure rate of 16% in the stenting arm. No other failures were identified through the one-year follow-up period. Additionally, the trial protocol allowed for cross over for patients in the medical arm if the primary endpoint was reached. An additional 3 patients were stented after failing medical therapy in the medical arm. None of these patients had recurrent symptoms in the follow-up period. As such, the overall rate of hard TIA or stroke within 1 year for patients receiving stenting was 10%. On the contrary, a total of 7 patients were randomised to the medical arm. Of these patients, 4 had a hard TIA or stroke within 1 year, for a clinical failure rate of 57% in the medical arm.
Conclusion In this small subgroup of the VISSIT Trial, Intracranial stenting is superior to medical therapy alone in patients whom have previously failed medical therapy. Future studies should focus on patient selection within this high-risk patient population.
Disclosures B. Woodward: 2; C; Codman Neurovascular.
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