Association between time to treatment and clinical outcomes in endovascular thrombectomy beyond 6 hours without advanced imaging selection.
The effectiveness and safety of endovascular thrombectomy (EVT) in the late window (6-24 hours) for acute ischemic stroke (AIS) patients selected without advanced imaging is undetermined. We aimed to assess clinical outcomes and the relationship with time-to-EVT treatment beyond 6 hours of stroke onset without advanced neuroimaging.
Patients who underwent EVT selected with non-contrast CT/CT angiography (without CT perfusion or MR imaging), between October 2015 and March 2020, were included from a national stroke registry. Functional and safety outcomes were assessed in both early (<6 hours) and late windows with time analyzed as a continuous variable.
Among 3278 patients, 2610 (79.6%) and 668 (20.4%) patients were included in the early and late windows, respectively. In the late window, for every hour delay, there was no significant association with shift towards poorer functional outcome (modified Rankin Scale (mRS)) at discharge (adjusted common OR 0.98, 95% CI 0.94 to 1.01, p=0.27) or change in predicted functional independence (mRS ≤2) (24.5% to 23.3% from 6 to 24 hours; aOR 0.99, 95% CI0.94 to 1.04, p=0.85). In contrast, predicted functional independence was time sensitive in the early window: 5.2% reduction per-hour delay (49.4% to 23.5% from 1 to 6 hours, p=0.0001). There were similar rates of symptomatic intracranial hemorrhage (sICH) (3.4% vs 4.6%, p=0.54) and in-hospital mortality (12.9% vs 14.6%, p=0.33) in the early and late windows, respectively, without a significant association with time.
In this real-world study, there was minimal change in functional disability, sICH and in-hospital mortality within and across the late window. While confirmatory randomized trials are needed, these findings suggest that EVT remains feasible and safe when performed in AIS patients selected without advanced neuroimaging between 6-24 hours from stroke onset.
Dhillon PS
,Butt W
,Podlasek A
,McConachie N
,Lenthall R
,Nair S
,Malik L
,Bhogal P
,Makalanda HLD
,Spooner O
,Krishnan K
,Sprigg N
,Mortimer A
,Booth TC
,Lobotesis K
,White P
,James MA
,Bath P
,Dineen RA
,England TJ
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Safety and Efficacy of Thrombectomy in Vietnamese Stroke Patients Selected through Perfusion Imaging with an Onset Time between 6 and 24 Hours.
Recent trials have demonstrated the remarkable benefit of endovascular treatment (EVT) up to 24 h in patients with large vessel occlusion (LVO) and target mismatch profiles; however, benefits of late-window EVT in Vietnamese population remain poorly understood. This study aims to evaluate the real-world outcomes of EVT in acute ischemic stroke (AIS) patients selected using perfusion imaging within the 6-24-h window.
This is a prospective study of consecutive patients with anterior circulation LVO stroke who underwent EVT within 6-24 h after last known well between August 2022 and March 2024. Patients were selected based on the DAWN/DEFUSE-3 criteria (Perfusion-RAPID, iSchemaView). The primary outcome was the proportion of patients with functional independence at 90 days (modified Rankin Scale score of 0-2). The secondary outcomes were successful reperfusion defined by thrombolysis in cerebral infarction (TICI) ≥2b on the final procedure and subgroup analysis between good (hypoperfusion intensity ratio [HIR] <0.4) and poor collaterals (HIR ≥0.4) groups. Safety outcomes were mortality rate and symptomatic intracranial hemorrhage (sICH).
Of 122 enrolled patients, 68% met inclusion criteria of DEFUSE-3 trial, 61% met DAWN trial criteria. Mean age was 66 years, median baseline NIHSS was 13, median time from stroke onset to hospital arrival was 12.55 h (9.50-16.48), and median infarct volume was 11.5 mL. The rate of functional independence at 90 days was 45.9%. Successful reperfusion (TICI score of ≥2b) was achieved by 83.6% of cases. The 90-day mortality rate was 10.7%; sICH was reported in 8 patients (6.6%). Patients with good collaterals had better functional outcome.
This real-world observational study suggests that late-window EVT may be safe and effective in eligible Vietnamese patients selected based on perfusion imaging, thus supporting its practical use in this patient population. HIR is a robust indicator of collateral status and could made it a valuable addition to stroke imaging workup in clinical setting.
Pham BN
,Tran HTM
,Nguyen ATT
,Pham HN
,Truong ATL
,Nguyen TQ
,Nguyen HBT
,Nguyen TQ
,Do HQ
,Le TVS
,Tran VT
,Nguyen RA
,Nguyen H
,Nguyen TB
,Nguyen TH
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Balloon guide catheters for endovascular thrombectomy in patients with acute ischaemic stroke due to large-vessel occlusion in China (PROTECT-MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial.
The effectiveness of using a balloon guide catheter during endovascular thrombectomy in patients with acute ischaemic stroke due to large vessel occlusion of the anterior circulation remains uncertain. We aimed to assess the effectiveness and safety of using a balloon guide catheter during endovascular thrombectomy, compared with using a conventional guide catheter, in this patient population.
We conducted a multicentre, open-label, blinded-endpoint, randomised controlled trial at 28 hospitals in China. Adults aged 18 years or older with acute ischaemic stroke who were able to receive endovascular thrombectomy within 24 h after symptom onset, according to local guidelines, were eligible. Patients were randomly assigned (1:1) to the balloon guide catheter group or the conventional guide catheter group using a central internet-based system with a minimisation algorithm. The treating physicians and patients were aware of treatment allocation, but clinical outcomes were collected by local trained physicians who were masked. Neurological assessments were performed at baseline, 24 h after randomisation, and at 7 days or hospital discharge (whichever occurred first). The primary outcome was functional recovery, assessed by change in modified Rankin Scale (mRS) scores (ranging from 0 [no symptoms] to 6 [death]) at 90 days in the intention-to-treat population and obtained from structured interviews. Treatment effect was estimated using ordinal logistic regression with adjustment for site and baseline prognostic factors (time from symptom onset to randomisation, the preferred thrombectomy strategy, baseline National Institutes of Health Stroke Scale score, prestroke function [estimated mRS score], and age). This trial is registered with ClinicalTrials.gov, NCT05592054 (terminated).
Between Feb 7 and Nov 13, 2023, 1698 patients were assessed for eligibility and 329 were randomly assigned to the balloon guide catheter group (n=164) or conventional guide catheter group (n=165) when the trial was paused and subsequently terminated on April 18, 2024, due to safety concerns. The median age was 69 years (IQR 59-76). Of 329 patients, 201 (61%) were male and 128 (39%) were female. Participants in the balloon guide catheter group had significantly worse scores on the mRS at 90 days than those in the conventional guide catheter group (adjusted common odds ratio 0·66 [95% CI 0·45-0·98]; p=0·037). All-cause mortality at 90 days was numerically higher in the balloon guide catheter group than in the conventional guide catheter group (39 [24%] vs 26 [16%]). There were no statistically significant differences between groups in intracranial haemorrhage, symptomatic intracranial haemorrhage, or other serious adverse events.
Compared with conventional guide catheters, the use of balloon guide catheters led to worse functional recovery in patients receiving endovascular thrombectomy for intracranial large vessel occlusion. Future studies are needed to confirm these results.
National Natural Science Foundation of China, Shanghai Hospital Development Center, Biopharma Industry Promotion Center Shanghai, and Ton-bridge Medical Technology.
For the Chinese translation of the abstract see Supplementary Materials section.
Liu J
,Zhou Y
,Zhang L
,Li Z
,Chen W
,Zhu Y
,Yao X
,Zhang L
,Liu S
,Peng Y
,Wei M
,Zhang Q
,Shu H
,Wang S
,Liu W
,Wan S
,Li T
,Fang Y
,Han H
,Zhang G
,Huang L
,Wang F
,Cheng G
,Gao L
,Shi H
,Han J
,Luo Y
,Li S
,Cai C
,Yin R
,Jin Z
,Shao C
,Tian B
,Zhang Y
,Li Q
,Zhang Y
,Zhang P
,Li B
,Xing P
,Shen H
,Zhu X
,Zhang X
,Hua W
,Shen F
,Huyan M
,Chen R
,Zuo Q
,Li Q
,Huang Q
,Xu Y
,Deng B
,Zhao R
,Goyal M
,Zhang Y
,Yang P
,PROTECT-MT Investigators
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