Normobarisk hyperoxi og endovaskulær behandling ved iskæmisk slagtilfælde
Normobarisk hyperoxi kombineret med endovaskulær behandling forbedrer funktionelle udfald hos patienter med akut iskæmisk slagtilfælde forårsaget af stor-karsoklusion. Denne undersøgelse blev udført i et multicenter, randomiseret, enkeltblindet, sham-kontrolleret design og inkluderede patienter fra 26 omfattende slagtilfældecentre i Kina [source_link].
Studiet omfattede 282 patienter i alderen 18-80 år, der præsenterede sig inden for 6 timer efter et akut iskæmisk slagtilfælde. Patienterne blev randomiseret til at modtage enten normobarisk hyperoxi (100% ilt ved 10 L/min i 4 timer) plus endovaskulær behandling eller sham-behandling (100% ilt ved 1 L/min) plus endovaskulær behandling. Randomiseringen blev udført 1:1, og deltagere samt bedømmere var blinde for behandlingsgrupperne.
Det primære endepunkt var den modificerede Rankin Scale (mRS) ved 90 dage, vurderet i intention-to-treat populationen. Resultaterne viste, at medianen for mRS var signifikant bedre i hyperoxi-gruppen (2) sammenlignet med sham-gruppen (3) (justeret odds ratio 1,65; p=0,018). Der blev ikke observeret signifikante forskelle i dødelighed eller alvorlige bivirkninger mellem grupperne, hvilket indikerer, at normobarisk hyperoxi ikke øgede sikkerhedsrisikoen.
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**Title**: Normobaric Hyperoxia Combined with Endovascular Treatment for Acute Ischemic Stroke: A Randomized Controlled Trial
**Authors**: Weili Li et al.
**Publication**: *The Lancet*, 2025 Feb 8; 405(10477):486-497. DOI: 10.1016/S0140-6736(24)02809-5
**Abstract**:
**Background**:
Endovascular treatment enhances recanalization rates in acute ischemic stroke patients; however, many do not achieve favorable outcomes. This study investigates the impact of normobaric hyperoxia combined with endovascular treatment on functional outcomes over 90 days in patients with acute ischemic stroke due to large-vessel occlusion.
**Methods**:
– A multicenter, randomised, single-blind, sham-controlled trial conducted in 26 stroke centers in China.
– Participants: 18-80 years old with acute ischemic stroke due to large-vessel occlusion, treated within 6 hours of symptom onset.
– Random assignment (1:1) to receive either:
– Normobaric hyperoxia (100% oxygen at 10 L/min for 4 hours) + endovascular treatment
– Sham normobaric hyperoxia (100% oxygen at 1 L/min) + endovascular treatment
– Primary outcome: Ordinal scores on the modified Rankin Scale (mRS) at 90 days.
**Findings**:
– 473 patients screened; 282 randomized (140 hyperoxia, 142 sham).
– Median age: 65 years; 27% female.
– At 90 days, median mRS score:
– Normobaric hyperoxia group: 2 (IQR 1-4)
– Sham group: 3 (IQR 1-4)
– Adjusted odds ratio for improved functional outcome: 1.65 (95% CI 1.09-2.50; p=0.018).
– Mortality: 10% in hyperoxia, 12% in sham group.
– Serious adverse events: 20% in hyperoxia, 23% in sham.
**Interpretation**:
Normobaric hyperoxia significantly improves functional outcomes at 90 days in patients with acute ischemic stroke from large-vessel occlusion treated with endovascular methods, with no increase in safety concerns.
**Funding**:
Beijing Municipal Education Commission, Beijing Municipal Finance Bureau, National Natural Science Foundation of China.
**Keywords**:
Hyperoxia, Endovascular Treatment, Ischemic Stroke, Randomized Controlled Trial, Treatment Outcome.
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### Normobarisk Hyperoksi og Endovaskulær Behandling ved Iskæmisk Slagtilfælde
#### Introduktion
Iskæmisk slagtilfælde, en tilstand karakteriseret ved nedsat blodgennemstrømning til hjernen, kan medføre alvorlige neurologiske skader og langvarige handicap. Behandlingsstrategier er afgørende for at minimere hjerneskader og forbedre patienternes prognose. To tilgange, der har fået stigende opmærksomhed, er normobarisk hyperoksi og endovaskulær behandling. I denne artikel vil vi undersøge disse metoder, deres effektiviteter og hvordan de kan anvendes i behandlingen af iskæmisk slagtilfælde.
#### Normobarisk Hyperoksi
Normobarisk hyperoksi refererer til administrationen af ilt under normale trykforhold. Denne behandling anvender højere koncentrationer af ilt end det, der findes i atmosfæren, for at forbedre iltforsyningen til vævene. I tilfælde af iskæmisk slagtilfælde kan normobarisk hyperoksi have flere gavnlige effekter:
1. **Forbedret Oxygenering**: Ved at øge mængden af ilt i blodet kan normobarisk hyperoksi bidrage til at kompensere for den nedsatte iltforsyning til hjernen.
2. **Neurobeskyttelse**: Forskning tyder på, at normobarisk hyperoksi kan reducere den sekundære skade, der opstår efter et slagtilfælde ved at dæmpe inflammation og oxidativt stress.
3. **Stimulation af Angiogenese**: Behandlingen kan fremme dannelse af nye blodkar, hvilket kan være gavnligt for at genoprette blodtilførslen til det berørte hjerneområde.
Studier har vist lovende resultater, men det er stadig nødvendigt med mere forskning for at fastslå de optimale protokoller og langtidseffekterne af normobarisk hyperoksi.
#### Endovaskulær Behandling
Endovaskulær behandling, typisk i form af thrombektomi, er en procedure, hvor blodpropper, der blokerer blodgennemstrømningen til hjernen, fysisk fjernes. Denne metode har revolutioneret behandlingen af iskæmisk slagtilfælde, især når den anvendes tidligt efter symptomdebut. Nøglefordele ved endovaskulær behandling inkluderer:
1. **Hurtig Genoprettelse af Blodgennemstrømning**: Ved at fjerne blodproppen kan lægerne hurtigt genoprette blodgennemstrømningen, hvilket er kritisk for at minimere hjerneskader.
2. **Bedre Resultater**: Studier har vist, at patienter, der får endovaskulær behandling, generelt har bedre neurologiske resultater sammenlignet med dem, der kun modtager medicinsk behandling.
3. **Mindre Invasiv**: Denne procedure er mindre invasiv end traditionelle kirurgiske metoder og har typisk kortere restitutionsperioder.
#### Kombination af Behandlinger
Der er en stigende interesse i at kombinere normobarisk hyperoksi med endovaskulær behandling for at maksimere de positive effekter af begge metoder. Hypotesen er, at normobarisk hyperoksi kan supplere den hurtige genoprettelse af blodgennemstrømning ved at yderligere forbedre iltforsyningen til det berørte hjerneområde og reducere den neurologiske skade.
Tidlige studier har antydet, at denne kombination kan føre til mere favorable resultater, men der er behov for større kliniske forsøg for at bekræfte disse fund og fastlægge de bedste behandlingsprotokoller.
#### Konklusion
Normobarisk hyperoksi og endovaskulær behandling repræsenterer to lovende tilgange til behandling af iskæmisk slagtilfælde. Mens endovaskulær behandling har vist sig at være effektiv til hurtigt at genoprette blodgennemstrømningen, kan normobarisk hyperoksi bidrage til at forbedre iltforsyningen og beskytte hjernen mod yderligere skade. Kombinationen af disse behandlinger kan muligvis føre til bedre resultater for patienter, men mere forskning er nødvendig for at optimere disse strategier. Det er vigtigt at fortsætte med at udforske og evaluere nye behandlingsmetoder for at forbedre prognosen for personer, der lider af iskæmisk slagtilfælde.
**Title:** Normobaric Hyperoxia Combined with Endovascular Treatment for Acute Ischaemic Stroke: A Randomized Controlled Trial
**Citation:** Lancet. 2025 Feb 8;405(10477):486-497. doi: 10.1016/S0140-6736(24)02809-5.
**Authors:**
Weili Li^1, Jing Lan^1, Ming Wei^2, Lan Liu^1, Chengbei Hou^3, Zhifeng Qi^4, Chuanhui Li^5, Liqun Jiao^6, Qi Yang^7, Wenhuo Chen^8, Shuling Liu^9, Xincan Yue^10, Qinglin Dong^11, Haicheng Yuan^12, Zongen Gao^13, Xiangbin Wu^14, Changming Wen^15, Tong Li^16, Changchun Jiang^17, Di Li^18, Zuoquan Chen^19, Junfeng Shi^20, Wanchao Shi^21, Jinglin Yuan^22, Yijie Qin^11, Binglong Li^23, Marc Fisher^24, Wuwei Feng^25, Ke Jian Liu^26, Xunming Ji^27; OPENS-2 Investigators
**Affiliations:**
1. Beijing Institute of Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.
2. Beijing Institute of Brain Disorders; Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China.
3. Center for Evidence-Based Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.
4. Cerebrovascular Diseases Research Institute, Xuanwu Hospital, Capital Medical University, Beijing, China.
5. The Stroke Center, Xuanwu Hospital, Capital Medical University, Beijing, China.
6. Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
7. Department of Radiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
8. Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, China.
9. Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China.
10. Department of Neurocritical Care, Zhoukou Central Hospital, Zhoukou, China.
11. Department of Emergency Medicine, People’s Hospital of Rizhao, Rizhao, China.
12. Department of Neurology, Qingdao Central Hospital, Qingdao, China.
13. Department of Neurology, Central Hospital of Shengli Oil Field, Dongying, China.
14. Department of Neurology, Jiujiang University Affiliated Hospital, Jiujiang, China.
15. Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang, China.
16. Department of Neurology, The Second Nanning People’s Hospital, Nanning, China.
17. Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou, China.
18. Department of Neurointervention and Neurocritical Care, Dalian Municipal Central Hospital, Dalian, China.
19. Department of Neurosurgery, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, China.
20. Cerebrovascular Center, Nanshi Hospital of Nanyang, Nanyang, China.
21. Department of Neurosurgery, Peking University Binhai Hospital, Tianjin, China.
22. Department of Neurology, Beijing Daxing District People’s Hospital, Beijing, China.
23. Department of Neurology, Jinan Third People’s Hospital, Jinan, China.
24. Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
25. Department of Neurology, Duke University School of Medicine, Durham, NC, USA.
26. Department of Pathology, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, USA.
27. Beijing Institute of Brain Disorders, Ministry of Science and Technology, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.
**Abstract:**
**Background:**
Endovascular treatment has been shown to enhance the recanalization rates in patients suffering from acute ischaemic stroke. However, nearly half of these patients still experience suboptimal functional recovery post-treatment. This study investigates the efficacy of combining normobaric hyperoxia with endovascular treatment in improving functional outcomes within 90 days for patients with acute ischaemic strokes caused by large-vessel occlusions.
**Methods:**
This multicentre, randomized, single-blind, sham-controlled trial involved patients aged 18-80 years who presented within 6 hours of an acute ischaemic stroke caused by large-vessel occlusion in the anterior circulation. Participants were recruited from 26 comprehensive stroke centres across China. Eligible individuals were randomly assigned (1:1) to receive either normobaric hyperoxia with endovascular treatment or sham hyperoxia with endovascular treatment, with randomization balanced on demographic and clinical factors. Treatments were administered with blinding for both participants and assessors. Primary outcomes focused on the modified Rankin Scale (mRS) scores at 90 days.
**Findings:**
From April 22, 2021, to February 5, 2023, 473 patients were screened, with 282 randomly allocated to receive either normobaric hyperoxia plus endovascular treatment (n=140) or sham treatment (n=142). The median age was 65 years, and the cohort was predominantly male (73%). At the 90-day mark, the normobaric hyperoxia group exhibited a median mRS score of 2 (IQR 1-4), while the sham group had a score of 3 (1-4), yielding an adjusted common odds ratio of 1.65 (95% CI 1.09-2.50; p=0.018). Mortality at 90 days was 10% in the normobaric hyperoxia group compared to 12% in the sham group, with no significant safety concerns noted.
**Interpretation:**
Normobaric hyperoxia significantly enhanced functional outcomes in patients with acute ischaemic stroke due to large-vessel occlusion when combined with endovascular treatment, demonstrating safety without heightened risks.
**Funding:**
Supported by the Beijing Municipal Education Commission, Beijing Municipal Finance Bureau, and the National Natural Science Foundation of China.
**PMID:** 39922675
**DOI:** 10.1016/S0140-6736(24)02809-5
**Publication Types:**
– Randomized Controlled Trial
– Multicenter Study
**MeSH Terms:**
– Adult
– Aged
– Aged, 80 and over
– China
– Combined Modality Therapy
– Endovascular Procedures
– Female
– Humans
– Hyperoxia
– Ischemic Stroke
– Male
– Middle Aged
– Oxygen Inhalation Therapy
– Single-Blind Method
– Treatment Outcome
**Title**: Normobaric Hyperoxia and Endovascular Treatment for Acute Ischaemic Stroke: A Randomized Controlled Trial
**Citation**:
Lancet. 2025 Feb 8; 405(10477): 486-497.
doi: 10.1016/S0140-6736(24)02809-5.
—
**Authors**:
Weili Li, Jing Lan, Ming Wei, Lan Liu, Chengbei Hou, Zhifeng Qi, Chuanhui Li, Liqun Jiao, Qi Yang, Wenhuo Chen, Shuling Liu, Xincan Yue, Qinglin Dong, Haicheng Yuan, Zongen Gao, Xiangbin Wu, Changming Wen, Tong Li, Changchun Jiang, Di Li, Zuoquan Chen, Junfeng Shi, Wanchao Shi, Jinglin Yuan, Yijie Qin, Binglong Li, Marc Fisher, Wuwei Feng, Ke Jian Liu, Xunming Ji; OPENS-2 Investigators.
—
**Collaborators**:
The OPENS-2 Investigators include the authors listed above, along with additional contributors who participated in the study.
—
**Affiliations**:
1. Beijing Institute of Brain Disorders, Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China.
2. Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China.
3. Center for Evidence-Based Medicine, Xuanwu Hospital Capital Medical University, Beijing, China.
4. Cerebrovascular Diseases Research Institute, Xuanwu Hospital, Beijing, China.
5. The Stroke Center, Xuanwu Hospital, Beijing, China.
6. Department of Radiology, Beijing Chaoyang Hospital, Beijing, China.
7. Department of Neurology, Zhangzhou Affiliated Hospital, Fujian Medical University, China.
8. Additional various departments across multiple hospitals in China and the USA.
—
**Abstract**:
**Background**:
Endovascular treatment has been shown to increase recanalization rates in patients experiencing acute ischemic stroke; however, about half of these patients do not achieve favorable functional outcomes. This study aimed to assess the impact of combining normobaric hyperoxia with endovascular treatment on functional outcomes up to 90 days post-treatment for patients with acute ischemic stroke due to large-vessel occlusion.
**Methods**:
In this multicenter, randomized, single-blind, sham-controlled trial, patients aged 18-80 with acute ischemic stroke due to large-vessel occlusion in the anterior circulation were recruited from 26 stroke centers in China. Participants were randomly assigned to receive either normobaric hyperoxia plus endovascular treatment or sham treatment plus endovascular treatment. The treatment involved inhaling 100% oxygen at a flow rate of 10 L/min for 4 hours. The primary outcome was the modified Rankin Scale (mRS) score at 90 days, assessed in an intention-to-treat population.
**Findings**:
Between April 22, 2021, and February 5, 2023, 473 patients were screened, with 282 randomly assigned to the treatment groups (140 received normobaric hyperoxia, while 142 received sham treatment). The median age was 65 years, with a predominance of male participants (73%). At 90 days, the median mRS score was lower in the hyperoxia group (2 vs. 3 in the sham group), indicating improved outcomes (adjusted common odds ratio 1.65 [95% CI 1.09-2.50]; p=0.018). Mortality rates and serious adverse events were similar between groups.
**Interpretation**:
For patients with acute ischemic stroke from large-vessel occlusion who were candidates for endovascular treatment, normobaric hyperoxia significantly improved functional outcomes at 90 days compared to sham treatment, without increasing safety risks.
**Funding**:
This study was supported by the Beijing Municipal Education Commission, Beijing Municipal Finance Bureau, and the National Natural Science Foundation of China.
—
**Publication Types**:
– Randomized Controlled Trial
– Multicenter Study
**MeSH Terms**:
– Adult
– Aged
– Hyperoxia
– Ischemic Stroke
– Oxygen Inhalation Therapy
– Treatment Outcome
**PMID**: 39922675
**DOI**: 10.1016/S0140-6736(24)02809-5