ESOC 2022: Trial and Research Reviews
Neurology Learning Network Section Editor, Amrou Sarraj, MD, shares study findings from 4 presentations given at the European Stroke Organisation Conference that took place May 3 to 6, 2022 in Lyon, France. Dr Sarraj highlights the RACECAT and PEACH trials as well as showcases information regarding the benefits of flying intervention teams and intraventricular fibrinolysis.
Drip-and-Ship vs Mothership Transfer Protocols in Patients With Intracranial Hemorrhage: Secondary Analysis of RACECAT Trial
In this population-based, multicenter, cluster-randomized clinical trial, researched aimed to examine the impact of prehospital transfers in patients with spontaneous intracranial hemorrhage (ICrH). Of the 1401 RACECAT patients, 314 with ICrH were included in this analysis; 173 randomized to the drip-and-sip (Local-SC) group compared with 141 in the mothership (EVT-SC) group.
Of participants, approximately 96% had intracerebral hemorrhage (ICH) and approximately 4% had subarachnoid hemorrhage (SAH). Patients assigned to the EVT-SC group had 70 km longer transfers and 40 minutes longer onset-to-arrival.
Researchers reported on the following results:
- Overall: Trend toward
- worse shift in mRS (cOR: 1.5 [0.997-2.25], P = .052)
- higher mortality (OR: 1.5 [0.985-2.431], P = .057)
- In patients with ICH (excluding SAHs):
- worse shift in mRS (acOR: 1.58 [1.04-2.41], P = .032)
- higher mortality (aOR: 1.59 [1.0 -2.537], P = .05)
The researchers concluded that there was worse functional outcomes and higher mortality in ICrH, especially ICH patients who were transferred to mothership in RACECAT. This study had limited generalizability due to inclusion of patients with RACE ≥5 and differences in geographic profiles.
Use of a Flying Intervention Team vs Patient Interhospital Transfer and Time to Endovascular Thrombectomy
This study was a nonrandomized, controlled intervention study, with a comparison of deployment of a Flying Intervention Team (FIT) vs patient interhospital transfer in a German nonurban region with 13 primary telemedicine-associated stroke centers.
Of the 157 patients, 72 received flying care, with 60 (83%) endovascular thrombectomy (EVT); whereas 85 were transferred with 57 (67%) of them receiving EVT. Median (IQR) decision to procedure time was 58 (51-71) minutes for FIT and 148 (124-177) minutes for patient transfers (difference: 90 minutes [95% CI, 75-103]; P < .001). No difference in functional status at 3 months was observed (median [IQR] score, 3 [2-6] vs 3 [2-5]; adj. cOR: 1.91 [95% CI, 0.96-3.88]; P = .07).
The researcher concludes that using a flying intervention team to local stroke centers was associated with significantly shorter time to EVT, as compared with transferring the patients to EVT-capable hospitals.
Association of Intraventricular Fibrinolysis With Clinical Outcomes in Patients With Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis
Intraventricular fibrinolysis (IVF) was compared with standard of care (SoC) in patients treated with external ventricular drainage caused by acute hydrocephalus. In this individual participant data (IPD) meta-analysis of 2 randomized clinical trials and 7 observational studies, 1501 patients were randomized into 2 groups, 596 IVF and 905 SoC.
The presenters reported on the following study outcomes:
- Primary outcome: mRS 0-3 at 6 months: IVF 42.1% vs SoC 30.5%, aOR: 1.69, 95% CI: 1.26-2.23, absolute treatment effects (ATE): 9.3% 95% CI: 4.4-14.1
- Secondary outcomes:
- Ordinal shift: cOR: 1.75, 95% CI: 1.39-2.17, P < .001
- Mortality: aOR: 0.47, 95% CI: 0.35-0.64, P < .001
- IVF within 48 hours:
- IPD cohort ATE: 15.2%, 95% CI: 8.6-21.8
- CLEAR cohort ATE: 13.3%, 95% CI: 3.3-23.4
Compared with SoC, IVF was associated with improved good functional outcome with lower mortality without increase in serious adverse effects. Treatment effect was strongly driven by patients receiving IVF within 48 hours.
Prevention of Epileptic Seizures in Acute Intracerebral Haemorrhage (PEACH): A Double-Blind Randomised Placebo-Controlled Trial
In this double-blind, randomized, placebo-controlled trial, 50 patients presenting with a non-traumatic intracerebral hemorrhage (ICH) within 24 hours were randomized to 2 groups, levetiracetam 1000 mg/d (n = 24) vs the placebo (n = 26), and followed for 6 weeks. Patients were monitored with continuous EEG recording for 48 hours.
The presenters noted:
- Levetiracetam showed a reduction in:
- number of patients with at least 1 seizure (levetiracetam 3/19 vs placebo 10/23, P = .043)
- total number of seizures (levetiracetam 6 in 19 vs placebo 158 in 23, P = .002)
- median duration of seizure (levetiracetam 67 seconds [46-300] vs placebo 780 seconds [380-1980], P = .028)
- No difference in safety:
- Serious adverse events: levetiracetam 21% vs placebo 35%, P = .352
- Death: levetiracetam 13% vs placebo 23%, P = .467
- Depression at 3 months: levetiracetam 6 (1-11) vs placebo 6 (4-9), P = .762
The results of this trial showed that levetiracetam, started within 48 hours and maintained for 6 weeks, proved safe and effective in preventing acute seizures in ICH. This study was terminated early due to COVID-19.
References
Ramos-Pachon A, Rodriguez-Luna D, Marti-Fabregas JM, et al. Drip-and-ship vs mothership transfer protocols in patients with intracranial hemorrhage: secondary analysis of RACECAT trial. Abstract presented at: European Stroke Organisation Conference; May 4-6, 2022; Lyon, France.
Hubert GJ, Hubert ND, Maegerlein C, et al. Use of a flying intervention team vs patient interhospital transfer and time to endovascular thrombectomy. Abstract presented at: European Stroke Organisation Conference; May 4-6, 2022; Lyon, France.
Kuramatsu JB. Association of intraventricular fibrinolysis with clinical outcomes in patients with intracerebral hemorrhage: an individual participant data meta-analysis. Presented at: European Stroke Organisation Conference; May 6, 2022; Lyon, France.
Derex L. Prevention of epileptic seizures in acute intracerebral haemorrhage (PEACH): a double-blind randomised placebo-controlled trial. Presented at: European Stroke Organisation Conference; May 6, 2022; Lyon, France.
