Article Text
Abstract
Background and purpose Hyperperfusion (HP) is a devastating complication associated with carotid artery stenting (CAS) or endarterectomy. The efficacy and safety of staged angioplasty (SAP) in patients with CAS at high risk of HP remains unclear. We sought to determine whether SAP is superior to regular CAS in patients with high risk of HP.
Methods A randomised, multicentre open-label clinical trial with blinded outcome assessment (STEP) was conducted. Patients with severe carotid stenosis at high risk of HP were randomly assigned (1:1) to the SAP or regular CAS group. The primary endpoint was hyperperfusion syndrome (HPS) and intracerebral haemorrhage (ICH) within 30 days after the procedure.
Results From November 2014 to January 2017, a total of 64 patients were enrolled in 11 centres. 33 patients were allocated to the SAP group and 31 to the regular CAS group. At 30 days, the rate of primary endpoint was 0.0% (0/33) in the SAP group and 9.7% (3/31) in the regular CAS group (absolute risk reduction (ARR), 9.7%; 95% CI −20.1% to 0.7%; p=0.11). As one of the secondary endpoints, the incidence of HP phenomenon (HPP) was lower in the SAP group than the regular CAS group (0.0% vs 22.6%, ARR,−22.6%; 95% CI −36.8% to −10.2%; p=0.04).
Conclusion The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.
Trial registration number NCT02224209.
- stroke
- stenosis
- stent
- technique
- intervention
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DM and BJ contributed equally.
Contributors DM, YoW, YiW and ZM conceived and led the project. HS, YS, QL, CF, JD, JY, WW, CJ, GZ, HD, LL and GP performed data collection and analysis. FG, NM, XS and LS performed quality control of the data. DM and BJ cowrote the manuscript with input from all coauthors.
Funding The work was supported by National Key Research and Development Program of China (2016YFC1301501) and Abbott Medical Devices Trading (Shanghai) Co., Ltd (no grant number).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was approved by Institutional Review Board of Beijing Tiantan Hospital, Capital Medical University. Patient’s information, including name, initial, or hospital numbers is not mentioned in this study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. Requests for access to the data used in this report will be considered by the corresponding author.