RT Journal Article
SR Electronic
T1 Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 95
OP 102
DO 10.1136/svn-2020-000391
VO 6
IS 1
A1 Dapeng Mo
A1 Baixue Jia
A1 Huaizhang Shi
A1 Yaxuan Sun
A1 Qingan Liu
A1 Chengzhe Fan
A1 Jianping Deng
A1 Jinglin Yuan
A1 Wei Wu
A1 Changchun Jiang
A1 Guilian Zhang
A1 Hanjun Du
A1 Ning Ma
A1 Feng Gao
A1 Xuan Sun
A1 Ligang Song
A1 Lian Liu
A1 Guangge Peng
A1 Yongjun Wang
A1 Yilong Wang
A1 Zhongrong Miao
A1 ,
YR 2021
UL http://svn.bmj.com/content/6/1/95.abstract
AB 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.