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 PARTICIPANTSA 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 MEASURESThe 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 RELEVANCEThis 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.
The treatment of complex cerebrovascular diseases (CCVDs) at the skull base, such as complex intracranial aneurysms, carotid-cavernous sinus fistulas, and intracranial artery traumatic injuries, is a difficult clinical problem despite advances in endovascular and surgical therapies. Covered stents or stent graft insertion is a new concept for endovascular treatment that focuses on arterial wall defect reconstruction, differing from endovascular lesion embolization or flow diverter therapies. In recent years, covered stents specifically designed for cerebrovascular treatment have been applied in the clinical setting, allowing thousands of patients with CCVDs to undergo intraluminal reconstruction treatment and achieving positive results, even in the era of flow diverters. Since there is no unified reference standard for the application of covered stents for treating CCVDs, it is necessary to further standardize and guide the clinical application of this technique. Thus, we organized authoritative experts in the field of neurointervention in China to write an expert consensus, which aims to summarize the results of covered stent insertion in the treatment of CCVDs and propose suitable standards for its application in the clinical setting. Based on the contents of this consensus, clinicians can use individualized intraluminal reconstruction treatment techniques for patients with CCVDs.
Background- In-stent restenosis (ISR) is a critical issue of endovascular therapy. The predictors for ISR are not fully explored. We aimed to investigate the predictors for ISR, especially the effect of collateral circulation on ISR after cerebral large artery stenting. Methods- From June, 2015 to June, 2018, a total of 312 patients, who performed stenting, with severe cerebral anterior circulation stenosis (≥ 70%), were enrolled. According to the flow velocity indicated by carotid artery ultrasound or Transcranial Doppler, the patients were divided into the ISR and no-ISR groups. Clinical data were collected, including age, sex, cerebrovascular risk factors, preoperative serum lipid, inflammatory markers, and platelet count, stent site, residual stenosis rate, drug therapy after stenting. The collateral circulation was graded according to digital subtraction angiography (DSA). Univariable and multivariable logistic regression analyses were performed to assess the potential risk factors related to restenosis in such patients. Results- Higher residual stenosis rate (median 11% vs 10%, p = 0.040), fewer patients received standard drug therapy ( 73.3% vs 89.4%, p = 0.001), more patients with poor collateral circulation (70.0% vs 41.0%, p = 0.007) were found in ISR group. Residual stenosis rate increased by 10% was associated with a 19.1% increase in restenosis risk. Good collateral circulation (OR 0.16, [95%CI, 0.04–0.49]; p = 0.002) and receiving standard drug therapy (OR 0.14, [95%CI, 0.05–0.58]; p = 0.002) were significantly related to the lower risk of ISR. Conclusion- Collateral circulation is an independent factor related with ISR after successful cerebral anterior circulation large artery stenting, and long-term standard drug therapy after stenting should be strictly carried out in such patients.
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