Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE): a multicentre, blinded-endpoint, randomised clinical trial

Dhillon, Permesh Singh; Butt, Waleed; Podlasek, Anna; Bhogal, Pervinder; Lynch, Jeremy; Booth, Thomas C; McConachie, Norman; Lenthall, Robert; Nair, Sujit; Malik, Luqman; Goddard, Tony; Carraro Do Nascimento, Vinicius; Barrett, Emma; Jethwa, Ketan; Krishnan, Kailash; Dineen, Robert A; England, Timothy J

Abstract

Background
The effect of temporary blood flow arrest during endovascular thrombectomy (EVT) for acute ischaemic stroke (AIS) is uncertain due to the lack of evidence from randomised controlled trials (RCT). We aimed to investigate whether temporary blood flow arrest during EVT using a balloon guide catheter improves intracranial vessel recanalisation compared to no flow arrest.
Methods
The ProFATE trial was a multicentre, randomised, participant and outcome-blinded trial at four thrombectomy centres in the United Kingdom. Adults with AIS due to anterior circulation large vessel occlusion were randomly assigned (1:1) by a central, web-based program with a minimisation algorithm, to undergo thrombectomy with temporary proximal blood flow arrest or no flow arrest during each attempt. The primary outcome was the proportion of participants achieving near-complete/complete vessel recanalisation (expanded Thrombolysis In Cerebral Infarction (eTICI) score of 2c or 3) at the end of the thrombectomy procedure, adjudicated by a blinded independent imaging core laboratory. Analyses were performed on the intention-to-treat population, adjusted for age, IV thrombolysis, onset-to-randomisation time, ASPECTS, occlusion site, randomisation site and NIHSS.
Results
Between 10 October 2021 and 27 June 2023, we recruited 134 participants, of whom 131 participants (mean age, 75 years; 62 [47%] women and 69 [53%] men) were included in the final analysis. 66 participants were allocated to the temporary blood flow arrest group and 65 to the non-flow arrest group. The proportion of participants with an eTICI 2c/3 score at the end of the endovascular procedure was 74.4% (49/66) in the flow arrest group and 70.8% (46/65) in the non-flow arrest group (adjusted odds ratio (aOR)=1.07, 95%CI 0.45-2.55, p=0.88). Amongst the prespecified secondary efficacy outcomes, a lower rate of emboli to a new vascular territory occured in the blood flow arrest group compared to the non-flow arrest group (1.5% vs 12.3%, aOR=0.04 [95%CI 0.01-0.53]; p= 0.014) and a higher rate of complete recanalisation (eTICI 3) after the first attempt in the flow arrest group vs non-flow arrest group (33.0% vs 15.3%; aOR=3.80 [95%CI 1.40-10.01]; p= 0.007). No between group differences were identified for the remaining procedural or clinical efficacy (modified Rankin scale at 90 days) or safety outcomes (worsening of the stroke severity at 24 hours, adverse events, symptomatic intracranial haemorrhage or mortality).
Discussion
Amongst patients presenting with anterior circulation large vessel occlusion AIS, temporary proximal blood flow arrest during EVT, compared to no flow arrest, did not significantly improve the near-complete/complete vessel recanalisation (eTICI 2c-3) at the end of the procedure. Larger RCTs are warranted to confirm or refute a clinically significant treatment effect of temporary flow arrest on the functional outcome following EVT.

Citation

Dhillon, P. S., Butt, W., Podlasek, A., Bhogal, P., Lynch, J., Booth, T. C., McConachie, N., Lenthall, R., Nair, S., Malik, L., Goddard, T., Carraro Do Nascimento, V., Barrett, E., Jethwa, K., Krishnan, K., Dineen, R. A., & England, T. J. (in press). Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE): a multicentre, blinded-endpoint, randomised clinical trial. Lancet,

• Journal Article Type: Article
• Acceptance Date: Nov 26, 2024
• Deposit Date: Dec 4, 2024
• Journal: Lancet
• Print ISSN: 0140-6736
• Electronic ISSN: 1474-547X
• Publisher: Elsevier
• Peer Reviewed: Not Peer Reviewed
• Keywords: Stroke, Thrombectomy, Endovascular, Balloon guide catheter, Emboli
• Public URL: https://nottingham-repository.worktribe.com/output/42814633