New player in stent retriever space demonstrates non-inferiority to Solitaire device

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A relatively new introduction to the field of endovascular therapy (EVT) for acute ischaemic stroke, the Skyflow stent retriever (Skyflow), has demonstrated non-inferiority with the Solitaire FR revascularisation device (Medtronic) in a randomised controlled trial (RCT)—the results of which are published online in the Journal of NeuroInterventional Surgery (JNIS) by Tianxiao Li (Henan Provincial People’s Hospital, Zhengzhou, China) and colleagues.

The study’s authors note in their report that mechanical thrombectomy is currently the standard treatment for acute ischemic stroke with large vessel occlusion (LVO) in the anterior circulation. As such, they devised an RCT with the aim of indicating whether thrombectomy using the Skyflow device could achieve a comparable level of safety and efficacy to the Solitaire FR device in acute ischaemic stroke patients.

The study in question was a prospective, multicentre, single-blinded, parallel, positive-controlled, non-inferiority clinical trial. The protocol for this RCT was initially outlined in Frontiers in Neurology in April 2021, with the investigators noting at the time that its success would be the basis for the Skyflow device being officially listed and applied in China.

The RCT included a total of 192 patients with intracranial anterior circulation LVO within eight hours from stroke onset, all of whom were randomised to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. Li and colleagues detail that 95 and 97 patients were included in the Skyflow group and the Solitaire FR group, respectively.

The authors state that the primary endpoint was the rate of successful reperfusion—characterised as a modified treatment in cerebral infarction (mTICI) scale score of ≥2b—after the procedure. In addition, secondary efficacy endpoints included the time from artery puncture to successful recanalisation (mTICI score 2b–3); National Institutes of Health Stroke Scale (NIHSS) scores at 24 hours (18–36 hours) and 7±2 days after the operation; modified Rankin Scale (mRS) scores and the rate of patients with mRS scores of zero, one, or two, 90±14 days after the procedure; and the success rate of instrument operation.

Safety endpoints were the rate of symptomatic intracranial haemorrhage (sICH) and subarachnoid haemorrhage (SAH) at 24-hour follow-up (18–36 hours) after the procedure, as well as incidence of adverse events and serious adverse events, all-cause mortality, and incidence of device defects.

Relaying the results, they report that successful reperfusion was ultimately achieved in 84 patients in the Skyflow group (88.4%) and 80 patients in the Solitaire FR group (82.5%). As such, their key finding was that Skyflow was non-inferior to Solitaire FR with regard to the primary outcome of the trial, in line with the criterion of a prespecified non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined centre effect and NIHSS scores.

The authors add that the rates of periprocedural sICH and SAH did not differ significantly between the two groups.

Concluding their report, Li and colleagues state that mechanical thrombectomy with the Skyflow stent retriever appears to be non-inferior to the Solitaire FR device in achieving successful reperfusion in patients with acute ischaemic stroke due to LVO.


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