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Original Investigation
January 4, 2022

Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis: A Randomized Clinical Trial

Author Affiliations
  • 1Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  • 2Stroke Center, Beijing Institute of Brain Disorders, Capital Medical University, Beijing, China
  • 3Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
  • 4Department of Neurology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
  • 5Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
  • 6Department of Cerebrovascular Disease, Hainan General Hospital, Haikou, Hainan, China
  • 7Department of Neurology, Yantai Yuhuangding Hospital, Yantai, Shandong, China
  • 8Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
  • 9Department of Neurology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China
  • 10Department of Neurology, Shenzhen Hospital of Southern Medical University, Shenzhen, Guangdong, China
  • 11Department of Neurology, The Southwest Hospital of Army Medical University, Chongqing, China
  • 12Department of Neurology, Xinqiao Hospital, Army Medical University, Chongqing, China
  • 13Department of Neurosurgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China
  • 14Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing, China
  • 15Department of Neurology, General Hospital of Lanzhou Military Command, Lanzhou, China
  • 16Neurointerventional Department, Henan Provincial People’s Hospital, Zhengzhou University, Zhengzhou, Henan, China
  • 17Department of Neurosurgery, Tianjin First Central Hospital, Tianjin, China
  • 18Department of Neurology, UCLA (University of California, Los Angeles)
  • 19Department of Neurology, University of California, Irvine, Irvine
JAMA Neurol. Published online January 4, 2022. doi:10.1001/jamaneurol.2021.4804
Key Points

Question  Is a drug-eluting stent (DES) superior to a standard bare-metal stent in reducing in-stent restenosis and stroke recurrence in patients with symptomatic high-grade intracranial atherosclerotic stenosis?

Findings  In this randomized clinical trial of 263 patients, a DES effectively reduced the incidence of in-stent restenosis and the risk of stroke recurrence in the target vessel territory in patients with symptomatic high-grade intracranial atherosclerotic stenosis.

Meaning  The results suggest that further examination of the safety and efficacy of DES for stroke prevention is warranted for patients with intracranial atherosclerotic stenosis.

Abstract

Importance  In-stent restenosis (ISR) is the primary reason for stroke recurrence after intracranial stenting in patients who were treated with a standard bare-metal stent (BMS). Whether a drug-eluting stent (DES) could reduce the risk of ISR in intracranial atherosclerotic stenosis (ICAS) remains unclear.

Objective  To investigate whether a DES can reduce the risk of ISR and stroke recurrence in patients with symptomatic high-grade ICAS.

Design, Settings, and Participants  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 with symptomatic high-grade ICAS were enrolled, randomized, and followed up for 1 year. Intention-to-treat data analysis was performed from April 1 to May 22, 2021.

Interventions  Patients were randomly assigned to receive DES (NOVA intracranial sirolimus-eluting stent system) or BMS (Apollo intracranial stent system) treatment in a 1:1 ratio.

Main Outcomes and Measures  The primary efficacy end point was ISR within 1 year after the procedure, which was defined as stenosis that was greater than 50% of the luminal diameter within or immediately adjacent to (within 5 mm) the implanted stent. The primary safety end point was any stroke or death within 30 days after the procedure.

Results  A total of 263 participants (194 men [73.8%]; median [IQR] age, 58 [52-65] years) were included in the analysis, with 132 participants randomly assigned to the DES group and 131 to the BMS group. The 1-year ISR rate was lower in the DES group than in the BMS group (10 [9.5%] vs 32 [30.2%]; odds ratio, 0.24; 95% CI, 0.11-0.52; P < .001). The DES group also had a significantly lower ischemic stroke recurrence rate from day 31 to 1 year (1 [0.8%] vs 9 [6.9%]; hazard ratio, 0.10; 95% CI, 0.01-0.80; P = .03). No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46).

Conclusions and Relevance  This trial found that, compared with BMSs, DESs reduced the risks of ISR and ischemic stroke recurrence in patients with symptomatic high-grade ICAS. Further investigation into the safety and efficacy of DESs is warranted.

Trial Registration  ClinicalTrials.gov Identifier: NCT02578069

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