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Randomized Controlled Trial
. 2021 Mar;6(1):95-102.
doi: 10.1136/svn-2020-000391. Epub 2020 Sep 24.

Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial

Dapeng Mo #  1 , Baixue Jia #  1 , Huaizhang Shi  2 , Yaxuan Sun  3 , Qingan Liu  4 , Chengzhe Fan  5 , Jianping Deng  6 , Jinglin Yuan  7 , Wei Wu  8 , Changchun Jiang  9 , Guilian Zhang  10 , Hanjun Du  11 , Ning Ma  1 , Feng Gao  1 , Xuan Sun  1 , Ligang Song  1 , Lian Liu  1 , Guangge Peng  1 , Yongjun Wang  12   13 , Yilong Wang  12   13 , Zhongrong Miao  14 ; STEP Study Group
Affiliations
Randomized Controlled Trial

Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial

Dapeng Mo et al. Stroke Vasc Neurol. 2021 Mar.

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.

Keywords: intervention; stenosis; stent; stroke; technique.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flowchart for patients with carotid artery stenosis at high risk of hyperperfusion. CAS, carotid artery stenting; ITT, intent-to-treat; mRS, modified Rankin Scale; PP, per-protocol; SAP, staged angioplasty.
See this image and copyright information in PMC

References

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