Comparison of Drug-Eluting Stents with Bare-Metal Stents in Patients with Symptomatic High-Grade Intracranial Atherosclerotic Stenosis

OBJECTIVES	To investigate whether a drug-eluting stent (DES) can reduce the risk of in-stent restenosis (ISR) and stroke recurrence in patients with symptomatic high-grade intracranial atherosclerotic stenosis (ICAS).
STUDY	A prospective, multicenter, open-label randomized clinical trial with blinded outcome assessment was conducted from April 27, 2015, to November 16, 2018, at 16 medical centers in China with a high volume of intracranial stenting. Patients were randomly assigned to receive a drug-eluting stent (NOVA intracranial sirolimus-eluting stent system; SINOMED) or a bare-metal stent (BMS - Apollo intracranial stent system; MicroPort NeuroTech) treatment in a 1:1 ratio.
POPULATION	Patients experiencing a TIA or non-disabling ischemic stroke caused by an ICAS lesion within 90 days prior to enrollment, under treatment for vascular risk factors, and at least 70% to 99% stenosis of the affected segment confirmed by DSA, with target artery diameter of 2 mm or larger with a lesion length of less than 15 mm.
ENDPOINTS	The primary efficacy endpoint was in-stent restenosis within 1 year after the procedure, defined as greater than 50% stenosis of the luminal diameter within or immediately adjacent to (within 5 mm) the implanted stent. The primary safety endpoint was any stroke or death within 30 days after the procedure. Secondary outcomes included technical success of stent placement (defined as stenosis <30% after the intervention); symptomatic ISR within 1 year, AIS in the target vessel territory from day 31 to 1, and hemorrhagic complications.

Comparison of Drug-Eluting Stents with Bare-Metal Stents in Patients with Symptomatic High-Grade Intracranial Atherosclerotic Stenosis - NOVA

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