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

Abstract

Background and purposeHyperperfusion (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.MethodsA 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.ResultsFrom 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).ConclusionThe 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 numberNCT02224209.

Staged angioplasty: A sensible approach to prevent hyperperfusion syndrome after carotid artery stenting? A meta-analysis

“…Ten studies were included in this meta-analysis. Among these, one article was randomized control trial 8 and nine articles were non-RCTs (four non-controlled studies 14–17 and five case-control studies 4 , 6 , 9–11 ). The main characteristics of the included studies are provided in Table 1.…”

“…The main characteristics of the included studies are provided in Table 1. Four studies included all patients with symptomatic carotid stenosis (defined as carotid stenosis associated with stroke or transient ischaemic attack), 8 , 14 , 16 , 17 four studies included patients with asymptomatic or symptomatic carotid stenosis, 6 , 9 , 11 , 15 and two studies only included patients with carotid stenosis without reference to asymptomatic or symptomatic stenosis. 4 , 10 Eight studies reported on elective procedures only, 4 , 6 , 9–11 , 15–17 two studies might recruit acute patients based on the description of their method.…”

“…4 , 10 Eight studies reported on elective procedures only, 4 , 6 , 9–11 , 15–17 two studies might recruit acute patients based on the description of their method. 8 , 14 The endpoint of efficacy and the endpoint of safety were evaluated in this meta-analysis as shown in Supplementary Table S3.…”

“…HPS was defined as clinical symptoms such as ipsilateral headache, vomiting, ipsilateral focal seizures, confusion, or focal neurological deficit without evidence of infarction after the procedure. 8 HPP was defined as an increase of CBF >100% than the baseline detected by TCD or other imaging exams. 8–10 ICH was defined as hyperdensities that were consistent with blood in the parenchyma of the culprit hemisphere on non-contrast CT. 8 , 11 The endpoint of safety was thromboembolic events.…”

“…8 HPP was defined as an increase of CBF >100% than the baseline detected by TCD or other imaging exams. 8–10 ICH was defined as hyperdensities that were consistent with blood in the parenchyma of the culprit hemisphere on non-contrast CT. 8 , 11 The endpoint of safety was thromboembolic events. The thromboembolic event was defined as the lesions detected by postoperative diffusion-weighted magnetic resonance imaging (DWI) after termination of all the procedure.…”