Baixue Jia1, Xuelei Zhang2, Ning Ma1, Dapeng Mo1, Feng Gao1, Xuan Sun1, Ligang Song1, Lian Liu1, Yiming Deng1, Xiaotong Xu1, Yong Zhang3, Zengpin Liu4, Sheng Guan5, Fan Zhang6, Bing Li7, Hongbo Zheng8, Xinfeng Liu9, Yajie Liu10, Kangning Chen11, Jie Shuai12, Jieqing Wan13, Jun Wang14, Xiangqun Shi15, Tianxiao Li16, Binge Chang17, David S Liebeskind18, Wengui Yu19, Zhongrong Miao1. 1. Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. 2. Stroke Center, Beijing Institute of Brain Disorders, Capital Medical University, Beijing, China. 3. Department of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. 4. Department of Neurology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. 5. Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. 6. Department of Cerebrovascular Disease, Hainan General Hospital, Haikou, Hainan, China. 7. Department of Neurology, Yantai Yuhuangding Hospital, Yantai, Shandong, China. 8. Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan, China. 9. Department of Neurology, Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China. 10. Department of Neurology, Shenzhen Hospital of Southern Medical University, Shenzhen, Guangdong, China. 11. Department of Neurology, The Southwest Hospital of Army Medical University, Chongqing, China. 12. Department of Neurology, Xinqiao Hospital, Army Medical University, Chongqing, China. 13. Department of Neurosurgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China. 14. Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing, China. 15. Department of Neurology, General Hospital of Lanzhou Military Command, Lanzhou, China. 16. Neurointerventional Department, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, Henan, China. 17. Department of Neurosurgery, Tianjin First Central Hospital, Tianjin, China. 18. Department of Neurology, UCLA (University of California, Los Angeles). 19. Department of Neurology, University of California, Irvine, Irvine.
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.
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.
Authors: Ashley M Wabnitz; Colin P Derdeyn; David J Fiorella; Michael J Lynn; George A Cotsonis; David S Liebeskind; Michael F Waters; Helmi Lutsep; Elena López-Cancio; Tanya N Turan; Jean Montgomery; L Scott Janis; Bethany Lane; Marc I Chimowitz Journal: Stroke Date: 2018-12-11 Impact factor: 7.914
Authors: Osama O Zaidat; Brian-Fred Fitzsimmons; Britton Keith Woodward; Zhigang Wang; Monika Killer-Oberpfalzer; Ajay Wakhloo; Rishi Gupta; Howard Kirshner; J Thomas Megerian; James Lesko; Pamela Pitzer; Jandira Ramos; Alicia C Castonguay; Stanley Barnwell; Wade S Smith; Daryl R Gress Journal: JAMA Date: 2015 Mar 24-31 Impact factor: 56.272
Authors: Colin P Derdeyn; David Fiorella; Michael J Lynn; Tanya N Turan; George A Cotsonis; Bethany F Lane; Jean Montgomery; L Scott Janis; Marc I Chimowitz Journal: Stroke Date: 2017-04-28 Impact factor: 7.914