Clinical question: In patients with symptomatic high-grade intracranial atherosclerotic stenosis (ICAS), does the use of a drug-eluting stent (DES) reduce the incidence of in-stent restenosis (ISR) and stroke recurrence compared to using a bare-metal stent (BMS)?
Background: ICAS is a common cause of stroke in North America (accounting for 8-10% of strokes) and is even more common in Asia (accounting for 30-50% of strokes). In previous trials, aggressive medical management was found to be the superior first-line treatment, but intracranial stenting is growing in popularity and safety. DES is known to reduce ISR in percutaneous coronary intervention compared to BMS, but it is unknown whether it gives the same advantage in patients with symptomatic high-grade ICAS.
Study design: Prospective, multi-center, open-label randomized clinical trial with blinded endpoint assessment
Setting: 16 medical centers in China from April 27, 2015, to November 16, 2018
Synopsis: 263 patients who experienced a transient ischemic attack (TIA) or non-disabling ischemic stroke caused by ICAS in the preceding 90 days were randomized to receive either BMS (131 patients) or DES (132 patients). There were 194 men and 69 women with a median age of 58 years (IQR, 52-65). The numbers of TIAs and ischemic strokes were similar in both groups. At one year, the DES group had lower rates of ISR with OR 0.24 (95% CI, 0.11-0.52) compared to the BMS group, and this result was observed in further subgroup analyses based on age, sex, risk factors, lesion characteristics, and procedural factors. Also at one year, DES reduced the risk of ischemic stroke recurrence compared to BMS with an HR of 0.10 (95% CI, 0.01-0.80). The rate of stroke or death within 30 days was not significantly different between DES and BMS (7.6% versus 5.3%; OR, 1.45; 95% CI, 0.54-3.94; P=0.46). Patients who received DES had higher rates of both intracranial hemorrhage and disabling or fatal stroke, but these differences were not statistically significant.
Bottom Line: Compared to BMS, DES may reduce the incidence of ISR and stroke in patients with ICAS; however, it may be associated with more periprocedural complications.
Citation: Jia B, et al. Comparison of drug-eluting stent with bare-metal stent in patients with symptomatic high-grade intracranial atherosclerotic stenosis: a randomized clinical trial. JAMA Neurol. 2022;79(2):176-184. doi:10.1001/jamaneurol.2021.4804
Dr. Snipe is a clinical instructor at Wake Forest School of Medicine, Winston-Salem, N.C.