Diferentes tipos de intervenciones endovasculares percutáneas para el accidente cerebrovascular isquémico agudo
Resumen
Antecedentes
El accidente cerebrovascular isquémico agudo (AIS por sus siglas en inglés) es la reducción brusca del flujo sanguíneo a una determinada zona del cerebro que provoca una disfunción neurológica. Se han desarrollado diferentes tipos de intervenciones endovasculares arteriales percutáneas, pero todavía no hay consenso sobre el tratamiento óptimo para las personas con AIS.
Objetivos
Comparar la seguridad y eficacia de diferentes tipos de intervenciones endovasculares arteriales percutáneas para el tratamiento de personas con AIS.
Métodos de búsqueda
Se hicieron búsquedas en el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials) (CENTRAL; número 4 de 12, 2022), MEDLINE Ovid (1946 hasta 13 mayo 2022), Embase (1947 hasta 15 mayo 2022), Science Citation Index Web of Science (1900 hasta 15 mayo 2022), Scopus (1960 hasta 15 mayo 2022), y China Biological Medicine Database (CBM; 1978 hasta 16 mayo 2022). También se realizaron búsquedas en el registro de ensayos ClinicalTrials.gov y en la Plataforma de registros internacionales de ensayos clínicos de la Organización Mundial de la Salud (OMS) hasta el 16 de mayo de 2022.
Criterios de selección
Ensayos controlados aleatorizados (ECA) que comparan una intervención endovascular arterial percutánea con otra en el tratamiento de pacientes adultos con diagnóstico clínico de AIS debido a oclusión de grandes vasos y confirmado por evidencia de diagnóstico por la imagen, las cuales incluyen tromboaspiración, trombectomía con recuperación de "stent", técnica combinada de aspiración y recuperación y fragmentación mecánica del trombo.
Obtención y análisis de los datos
Dos autores de la revisión realizaron de forma independiente las búsquedas bibliográficas, identificaron los ensayos elegibles y extrajeron los datos. Un tercer autor de la revisión participó en las discusiones para llegar a decisiones consensuadas cuando se produjeron discrepancias. Se evaluó el riesgo de sesgo y se aplicó el método GRADE para evaluar la calidad de la evidencia. El desenlace principal fue la tasa de la escala de Rankin modificada (mRS) de 0 a 2 a los tres meses. Los desenlaces secundarios incluyeron la tasa de trombólisis modificada en infarto cerebral (mTICI) de 2b a 3 tras el procedimiento, la mortalidad por todas las causas en un plazo de tres meses, la tasa de hemorragia intracraneal en diagnóstico por la imagen a las 24 horas, la tasa de hemorragia intracraneal sintomática a las 24 horas y la tasa de eventos adversos relacionados con el procedimiento en un plazo de tres meses.
Resultados principales
Cuatro ECA fueron elegibles. El metanálisis actual incluyó dos ensayos con 651 participantes que compararon la tromboaspiración con la trombectomía con recuperación de "stent". Se consideró que la calidad de la evidencia era alta en ambos ensayos según la herramienta de riesgo de sesgo RoB 2 de Cochrane.
No hubo diferencias significativas entre la tromboaspiración y la trombectomía con recuperación de "stent" en la tasa de mRS de 0 a 2 a los tres meses (razón de riesgos [RR] 0,97; intervalo de confianza [IC] del 95%: 0,82 a 1,13; p = 0,68; 633 participantes; dos ECA); tasa de mTICI de 2b a 3 tras el procedimiento (RR 1,01; IC del 95%: 0,95 a 1,07; p = 0,77; 650 participantes; dos ECA); mortalidad por todas las causas en el plazo de tres meses (RR 1,01; IC del 95%: 0,74 a 1,37; p = 0,95; 633 participantes; dos ECA); tasa de hemorragia intracraneal en diagnóstico por la imagen a las 24 horas (RR 1,03; IC del 95%: 0,86 a 1,24; p = 0,73; 645 participantes; dos ECA); tasa de hemorragia intracraneal sintomática a las 24 horas (RR 0.90, IC del 95%: 0,49 a 1,68; p = 0,75; 645 participantes; dos ECA); y tasa de eventos adversos relacionados con el procedimiento en un plazo de tres meses (RR 0,98, IC del 95%: 0,68 a 1,41; p = 0,90; 651 participantes; dos ECA).
Otros dos estudios incluidos no informaron diferencias en las comparaciones del tratamiento combinado versus la trombectomía con recuperación de "stent" o la tromboaspiración. Existe un ECA en curso.
Conclusiones de los autores
Esta revisión no estableció diferencias en la seguridad y efectividad entre el abordaje de tromboaspiración y la trombectomía con recuperación de "stent" para el tratamiento de las personas con AIS. Además, el grupo combinado no mostró ninguna ventaja evidente sobre ninguna de las dos intervenciones aplicadas por separado.
PICO
Resumen en términos sencillos
Diferentes tipos de tratamientos endovasculares percutáneos para el ictus isquémico agudo
Pregunta
¿Qué tipo de tratamiento endovascular es mejor en términos de seguridad y eficacia para las personas con ictus isquémico agudo (AIS)?
Antecedentes
El ictus es una de las causas más frecuentes de muerte y discapacidad en la actualidad. Diferentes tratamientos endovasculares (dentro de los vasos sanguíneos) (también llamados trombectomía) pretenden eliminar el coágulo sanguíneo causante del AIS para restablecer el flujo sanguíneo y revertir los síntomas del ictus. La tromboaspiración consiste en aspirar el coágulo mediante un tubo catéter fino. La trombectomía con recuperación de "stent" agarra y extrae el coágulo del vaso sanguíneo obstruido. También se ha demostrado que una técnica combinada de aspiración‐retirada es una forma eficaz de eliminar el coágulo sanguíneo. Sin embargo, no está claro qué tipo de trombectomía es mejor en el tratamiento del AIS.
Fecha de búsqueda
La búsqueda de estudios finalizó el 16 de mayo de 2022.
Características de los estudios
Se combinaron los datos de dos ensayos controlados aleatorizados (un tipo de estudio en el que los participantes se asignan al azar a uno de dos o más grupos terapéuticos) con un total de 651 participantes que presentaban AIS debido a la oclusión de grandes vasos confirmada mediante diagnóstico por la imagen, como la angiografía por tomografía computarizada (ATC) y la angiografía de sustracción digital (ASD). Estos ensayos se realizaron en múltiples centros y compararon la tromboaspiración con la trombectomía con recuperación de "stent". Otros dos estudios compararon la técnica combinada con la tromboaspiración y la trombectomía con recuperación de "stent" por separado.
Resultados clave
No hubo diferencias claras en la seguridad y eficacia de los dos abordajes (tromboaspiración y trombectomía con recuperación de "stent") en el manejo de los pacientes con AIS.
Calidad de la evidencia
La calidad de la evidencia de la revisión fue alta, aunque los médicos y los participantes sabían qué tratamiento se estaba administrando, lo que podría haber dado lugar a sesgos.
Authors' conclusions
Summary of findings
| Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke | |||||
| Patient or population: people with acute ischemic stroke Settings: hospital Intervention: stent‐retrieval thrombectomy Comparison: thrombo‐aspiration | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No. of participants | Quality of the evidence | |
|---|---|---|---|---|---|
| Risk with thrombo‐aspiration | Risk with stent‐retrieval thrombectomy | ||||
| Functional independence at 3 months (mRS 0 to 2) (primary outcome) | 497 per 1000 (408 to 562) | 482 per 1000
| RR 0.97 (0.82 to 1.13) | 633 | ⊕⊕⊕⊕ |
| Successful reperfusion (mTICI 2b to 3) postprocedure | 874 per 1000 (776 to 881) | 883 per 1000 | RR 1.01 (0.95 to 1.07) | 650 | ⊕⊕⊕⊕ |
| All‐cause mortality within 3 months | 204 per 1000 (151 to 280) | 206 per 1000
| RR 1.01 (0.74 to 1.37) | 633 | ⊕⊕⊕⊕ |
| Intracranial hemorrhage on imaging at 24 hours | 406 per 1000 (349 to 503) | 418 per 1000
| RR 1.03 (0.86 to 1.24) | 645 | ⊕⊕⊕⊕ |
| Symptomatic intracranial hemorrhage at 24 hours | 62 per 1000 (30 to 104) | 56 per 1000
| RR 0.9 (0.49 to 1.68) | 645 | ⊕⊕⊕⊕ |
| Procedure‐related adverse events within 3 months | 151 per 1000 (103 to 213) | 148 per 1000
| RR 0.98 (0.68 to 1.41) | 651 | ⊕⊕⊕⊕ |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; mRS: modified Rankin Scale; mTICI: modified Thrombolysis In Cerebral Infarction; RCT: randomized controlled trial; RR: risk ratio | |||||
| GRADE Working Group grades of evidence | |||||
Background
Description of the condition
Stroke is the second most common cause of mortality and the leading cause of disability globally. The social and economic burden caused by stroke is estimated to increase dramatically in the next 20 years, especially in low‐ and middle‐income countries (GBD 2016 Stroke Collaborators 2019; Rajsic 2019). Approximately 70% of stroke events globally are ischemic, while the rest are hemorrhagic (Feigin 2018). In Europe and the USA, the proportion of ischemic strokes is estimated to be as high as 80% to 87% of all strokes (Béjot 2016; Benjamin 2019).
Acute ischemic stroke (AIS) is defined as the abrupt reduction of blood flow to a region of the brain, resulting in loss of neurologic function (Heiss 1999; Zivin 1998). It has been reported that in the USA, based on nationwide data, patients with AIS could make up to 30 visits per 10,000 patients at the emergency department (Stuntz 2017). The main causes of AIS are thromboembolism due to large artery atherosclerosis and cardioembolism, and small vessel disease of the brain, which accounts for 25% to 30% of strokes (Joutel 2014). Other rare causes of AIS are arterial dissection, vasculitis, paradoxical embolism, and hematological disorders (Campbell 2019).
The diagnosis of AIS has become more accurate and rapid with the development of imaging technologies in recent years. The multiple imaging modalities could also provide real‐time information on many aspects of stroke pathophysiology. Computed tomography (CT) and magnetic resonance imaging (MRI) are two common modalities used for AIS assessment. Although CT is widely applied, MRI is superior in sensitivity to small infarction (El‐Koussy 2014). More recently, perfusion imaging and arterial spin labeling technology have been used for confirming the infarct core, as well as collateral circulation evaluation (Heidari 2020; Reimer 2018; Thamm 2019).
Description of the intervention
Treatment of AIS has the potential to reverse presented neurological deficits and improve patient outcomes (Kong 2018; Roger 2012; Stuntz 2017). Current treatments for AIS generally consist of antiplatelet therapy, intravenous thrombolysis, and endovascular thrombectomy. Antiplatelet therapy, including aspirin and clopidogrel, has been recommended for secondary stroke prevention (Powers 2018). Treatment with aspirin within 48 hours after onset of AIS has been shown to reduce the risk of recurrent stroke and improve outcomes (CAST 1997; IST 1997). The Clopidogrel in High‐risk patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial found dual antiplatelet therapy to be superior in preventing acute minor stroke or transient ischemic attack (TIA) than aspirin alone (Wang 2013). Recently, compared with aspirin alone, ticagrelor combined with aspirin was shown to lower the risk of the composite of stroke or death within 30 days for patients with a mild to moderate acute non‐cardioembolic ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 5 or less) or TIA who were not undergoing intravenous or endovascular thrombolysis; however, severe bleeding was more frequent with ticagrelor (Johnston 2020). The drugs used for intravenous thrombolysis mainly consisted of alteplase and tenecteplase. Alteplase—a recombinant form of tissue plasminogen activator (tPA), which cleaves plasminogen, degrades fibrin, and dissolves the thrombus—is regarded as the standard thrombolytic drug for AIS (Campbell 2019). The results of the third International Stroke Trial (IST‐3) demonstrated that alteplase treatment within six hours after ischemic stroke was associated with a small, non‐significant reduction in risk of death at three years, but among individuals who survived the acute phase, treatment was associated with a significant increase in long‐term survival (Berge 2016). In several trials, tenecteplase, a modified tPA that has a longer half‐life than alteplase and greater fibrin specificity, was found to be similar or superior to alteplase in the safety and efficacy of treating AIS (Coutts 2018; Tanswell 2002). However, in many of these trials, intravenous thrombolysis was restricted to the selection of an optimal time window and the main adverse effect of hemorrhage (Albers 2002; Emberson 2014; Hacke 1995; Koroshetz 1996; Whiteley 2016). Recently, the safety and effectiveness of percutaneous arterial endovascular interventions have become generally accepted in clinics. Endovascular interventions have been shown to improve the 90‐day functional outcome of patients and reduce the risk of mortality after AIS (Campbell 2018; Lin 2019). In addition, some randomized controlled trials (RCTs) have demonstrated the superiority of mechanical thrombectomy with medical therapy over medical therapy alone for people with AIS, in terms of neurological recovery, recanalization rates, and functional outcomes (Berkhemer 2015; Campbell 2015; Goyal 2015; Liu 2020; Yang 2020). However, the best methods for endovascular intervention are still controversial.
How the intervention might work
Percutaneous arterial endovascular interventions can be classified into thrombo‐aspiration, stent‐retrieval thrombectomy, aspiration‐retriever combined technique, and thrombus mechanical fragmentation. Each of these treatments has its own merits and limitations. However, the evidence on the optimal therapy with acceptable outcomes of safety and efficacy is still limited.
Aspiration thrombectomy, in particular A Direct Aspiration, First Pass Technique (ADAPT), is a type of endovascular treatment using an aspiration catheter alone that has superiority in terms of procedure duration, recanalization rates, cost‐effectiveness, and clinical outcomes (Delgado Almandoz 2016; Gory 2018b; Turk 2015).
Stent‐retrieval (SR) thrombectomy is used to retrieve thrombi and restore blood flow with a stent retriever, for instance, a self‐expanding stent, Trevo, and a three‐dimensional stent retriever (Saver 2015). Although endovascular therapy with mechanical thrombectomy devices was initially assessed as presenting disappointing outcomes (Broderick 2013; Ciccone 2013; Kidwell 2013), second‐generation devices focusing on SRs were recently introduced to treat AIS and found to be efficacious in improving functional outcomes (Rodrigues 2016). Two trials were designed to compare the ADAPT and SR techniques; however, the superiority between the interventions remains uncertain. The Contact Aspiration versus Stent Retriever for Successful Revascularization (ASTER) trial showed that first‐line thrombectomy with aspiration did not increase successful recanalization rates compared with SR, and there was no significant difference in clinical outcomes between the two technologies (Lapergue 2017). The result of the trial of aspiration thrombectomy versus stent retriever thrombectomy as first‐line approach for large vessel occlusion found that direct aspiration as first‐pass thrombectomy granted non‐inferior functional outcomes at 90 days compared with SR, and supported direct aspiration as a substitute to SR as first‐line therapy for stroke thrombectomy (Turk 2019). Even so, SR was ineffective in 20% to 30% of participants, especially for AIS patients with a hard clot, and the possibility of recanalization decreased as the attempts of recanalization increased (Baek 2018; Yoo 2017).
Aspiration‐retriever combined technique—including stent retriever partially retracted with intermediate catheter for mechanical thrombectomy (SWIM), the Solumbra or stent‐retriever‐assisted vacuum‐locked extraction (SAVE) technique, or stent retriever with local aspiration (SLRA)—has been shown to be fast and effective at first‐pass complete recanalization and to have better outcomes compared with direct aspiration and SR alone (Maus 2018; McTaggart 2017). However, this combined technology was costly during hospitalization and carried a higher risk of subarachnoid hemorrhage for AIS (Hesse 2018; Texakalidis 2020).
Thrombus mechanical fragment is a technology using a guide‐wire or snare to mechanically disrupt a thrombus (Lindekleiv 2018). Mechanical disruption of the clot in combination with intra‐arterial administration of a thrombolytic drug showed a high rate of recanalization and clinical improvement (Qureshi 2002). However, the potential risk of distal embolization of thrombus fragments was also found in some studies (Qureshi 2002; Yoneyama 2002). Consequently, there is a need for future research to identify the safety and efficacy of thrombus mechanical fragment.
Why it is important to do this review
Acute ischemic stroke (AIS) is a common disease worldwide with high morbidity and mortality (Donnan 2008). It accounts for approximately 87% of strokes and is an important social and economic issue for the public health system in the USA (Heidenreich 2011; Pereira 2015; Roger 2012; Stuntz 2017). AIS treatment has the potential to reverse presenting neurological deficits and improve patient outcomes (Kong 2018; Roger 2012; Stuntz 2017). The safety and effectiveness of percutaneous arterial endovascular intervention have been generally accepted in clinics, and it has been shown that endovascular interventions can improve patients' 90‐day functional outcome and reduce the risk of mortality after AIS (Campbell 2018; Lin 2019). Percutaneous arterial endovascular interventions, comprising thrombo‐aspiration, stent‐retrieval thrombectomy, aspiration‐retriever combined technique, and thrombus mechanical fragmentation, have been shown to be promising in previous meta‐analyses or clinical trials (Amaral‐Silva 2011; Anadani 2019; Gory 2018a; Lindekleiv 2018; Nogueira 2018; Saver 2015; Texakalidis 2020). However, as the variable mechanisms of these methods may lead to different clinical consequences, it remains uncertain which percutaneous arterial endovascular intervention is best, and the relative efficacy and safety of different methods needs to be clarified. For example, the superiority of the two most commonly used methods, aspiration and stent‐retriever thrombectomy, is currently debated and remains uncertain based on previous meta‐analysis and trials (Boulanger 2019; Lapergue 2017; Tsang 2018). The most recently published results of the comparison of direct aspiration versus stent retriever as a first approach showed the non‐inferiority of first‐line thrombo‐aspiration to stent‐retriever use with respect to good clinical outcome, which may provide new clinical evidence and insight in strategy selection (Turk 2019). Also, thrombectomy using a combination of stent‐retriever and aspiration has recently been debated (Nogueira 2018). A new perspective was proposed that the combination of these two methods may achieve better clinical efficacy than either method alone, but possibly at the risk of safety (Texakalidis 2020). Furthermore, clinical evidence relating to other methods, such as thrombus mechanical fragmentation and intra‐arterial sonothrombolysis, is sparse, and their efficacy remains largely unknown when compared with other methods.
Currently, clinical guidelines have not provided high‐quality evidence on the first choice between these mechanical thrombectomy modalities. Guidelines from the American Heart Association/American Stroke Association (AHA/ASA) only recommend that stent retrievers remain the first choice for the early management of patients with AIS, based on the results of the ASTER trial (Lapergue 2017). In addition, the 2019 European Stroke Organisation (ESO) ‐ European Society for Minimally Invasive Neurological Therapy (ESMINT) guidelines on mechanical thrombectomy in AIS recommend that there is no evidence that thrombo‐aspiration alone increases the rate of reperfusion over thrombectomy using a stent retriever, but with very low‐quality evidence. Also, the majority of experts believe that a direct‐aspiration first‐pass technique (ADAPT) may be used as standard first‐line treatment, followed by stent retriever thrombectomy as rescue therapy if needed (Turc 2019). Furthermore, neither guideline mentions thrombus mechanical fragmentation. Considering the inconsistent recommendations among guidelines from different countries and the recently published results of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial, an update and new insight of this issue is necessary and urgent. A systematic review and meta‐analysis, which allows direct comparison and establishes a hierarchy both in terms of safety and effectiveness, will therefore be of great value to assess these different percutaneous arterial endovascular interventions for AIS patients.
This systematic review and meta‐analysis aimed to provide the most comprehensive and recent evidence for choosing the best percutaneous arterial endovascular intervention for AIS patients. It will help to update clinical guidelines, reveal insights on directions for future research, and guide clinical strategy selection for clinicians worldwide.
Objectives
To compare the safety and efficacy of different types of percutaneous arterial endovascular interventions for treating people with acute ischemic stroke (AIS).
Methods
Criteria for considering studies for this review
Types of studies
We included randomized controlled trials (RCTs) that compared one type of percutaneous endovascular intervention with another.
Types of participants
We included adult participants (age 18 years and older) who had a clinical diagnosis of acute ischemic stroke (AIS) due to large vessel occlusion. Large vessel occlusion included anterior or posterior circulation occlusions and was confirmed by either transcranial Doppler (TCD), computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA). The use of intravenous thrombolysis treatment was permitted.
We excluded participants who met any of the following criteria: those with an absence of large vessel occlusion on non‐invasive imaging including TCD, CTA, or MRA; clinical history, past imaging, and clinical judgment suggesting that the intracranial occlusion was chronic.
Types of interventions
We included studies that evaluated one or more of the following percutaneous arterial endovascular interventions: thrombo‐aspiration, stent‐retrieval thrombectomy, aspiration‐retriever combined technique, thrombus mechanical fragmentation.
Types of outcome measures
Primary outcomes
The main outcome was rate of functional independence at three months (defined as a modified Rankin Scale [mRS] of 0 to 2).
Secondary outcomes
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Rate of successful reperfusion. We defined successful reperfusion separately as a modified Thrombolysis In Cerebral Infarction (mTICI) score of 2b to 3 at the first‐line strategy alone and at the end of all procedures, which was determined by postinterventional DSA.
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Mortality from any cause within three months.
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Rate of intracranial hemorrhage (ICH) on imaging at 24 hours, in accordance with the European Cooperative Acute Stroke Study III classification.
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Rate of symptomatic ICH at 24 hours, defined as any ICH (including intracerebral, subarachnoid, and intraventricular hemorrhages) visualized on follow‐up imaging and associated with an NIHSS score of 4 or more or that resulted in death.
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Rate of procedure‐related adverse events within three months (subarachnoid hemorrhage, new cerebral infarction, arterial dissection, and arterial perforation).
Search methods for identification of studies
We searched for trials in all languages, arranging for the translation of relevant articles where necessary.
Electronic searches
We searched the Cochrane Stroke Group trials register and the following electronic databases.
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Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (Issue 4 of 12, 2022) (Appendix 1).
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MEDLINE Ovid (1946 to 13 May 2022) (Appendix 2).
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Embase (1947 to 15 May 2022) (Appendix 3).
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Science Citation Index Web of Science (1900 to 15 May 2022) (Appendix 4).
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Scopus (1960 to 15 May 2022) (Appendix 5).
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China Biological Medicine Database (CBM; 1978 to 16 May 2022) (Appendix 6).
We developed the MEDLINE search strategy with the help of the Cochrane Stroke Information Specialist, and adapted it for searching the other databases. The stroke and intervention subject searches have been linked to the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomized trials in MEDLINE: sensitivity maximizing version (2008 revision) (lines 43‐52), as referenced in Box 3.d in the Technical Supplement to Chapter 4 of the Cochrane Handbook for Systematic Reviews of Interventions (Lefebvre 2021).
We searched the following ongoing trials registers.
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US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov/; searched 16 May 2022) (Appendix 7).
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World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (www.who.int/clinical-trials-registry-platform; searched 16 May 2022) (Appendix 8).
Searching other resources
In an effort to identify further published, unpublished, and ongoing trials, we:
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checked the bibliographies of included studies and any relevant systematic reviews identified for further references to relevant trials (searched 16 May 2022);
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contacted original authors for clarification and further data if trial reports were unclear;
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contacted experts/trialists/organizations in the field to obtain additional information on relevant trials where necessary;
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conducted a search of various grey literature sources, dissertations and theses databases, and databases of conference abstracts, including:
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Canadian Coordinating Office for Health Technology Assessment's (CCOHTA's) resource (searched 15 May 2022);
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British Library EThOS (UK E‐Theses Online Service; searched 15 May 2022);
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ProQuest Dissertation and Theses Global (searched 15 May 2022).
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Data collection and analysis
Selection of studies
Two review authors (XW and YF) independently screened the titles and abstracts of the references identified as a result of the searches, excluding obviously irrelevant reports. We retrieved the full‐text articles for the remaining references, and two review authors (XW and YF) independently screened the full‐text articles and identified studies for inclusion, and recorded reasons for exclusion of the ineligible studies. Any disagreements were resolved through discussion or by consulting a third review author (TW) if required. We collated multiple reports of the same study so that each study, rather than each reference, was the unit of interest in the review. We recorded the selection process and completed a PRISMA flow diagram (see Figure 1) (Liberati 2009).
Study flow diagram.
Data extraction and management
Two review authors (XW and YF) independently extracted data from the included studies in accordance with a standardized data extraction form. All relevant information of interest was extracted as follows.
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Methods: study design, publication date, country, and single center or multiple centers.
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Characteristics of participants: number, mean age, age range, ethnicity, gender, medical history, site of occlusion by angiography, admission NIHSS score, baseline Alberta Stroke Program Early CT Score (ASPECTS), and inclusion and exclusion criteria.
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Characteristics of interventions: endovascular intervention strategy and procedural time.
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Outcomes: primary and secondary outcomes, and time points reported.
Any disagreements regarding data extraction were resolved through the assistance of a third review author (TW). We contacted the original study authors for any missing or unclear information in the full text. For dichotomous data, we extracted the number of participants undergoing the event and the total number of participants in each arm of the trial. For continuous data, we extracted the mean value and standard deviation (SD) for the variation in each arm of the trial as well as the total number in each group.
Assessment of risk of bias in included studies
Two review authors (KY and YF) independently assessed the risk of bias of each included study using the criteria outlined in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022). Any disagreements were resolved by discussion or by involving another review author (TW). We assessed risk of bias according to the following domains.
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Bias arising from the randomization process
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Bias due to deviations from intended interventions
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Bias due to missing outcome data
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Bias in measurement of the outcomes
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Bias in selection of the reported result
We used Cochrane's risk of bias tool (RoB 2) to assess risk of bias in the included trials (Higgins 2022). We provided information from the study report together with a justification for our judgment in the risk of bias tables.
Measures of treatment effect
For dichotomous data, we used risk ratios (RRs) with 95% confidence intervals (CIs) (Boissel 1999). For continuous data, if study authors used different tools to measure outcomes, we would transform the data into standardized mean differences (SMDs) with 95% CIs. We analyzed continuous data as mean differences (MDs) with 95% CIs if the outcome data were measured using the same tool. In the case of missing summary data, such as missing SDs, we acquired these data and used calculations in accordance with Chapter 6 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022). For each likely pairwise comparison, we presented relative treatment effects as the summary relative effect sizes (RRs) with 95% CIs.
Unit of analysis issues
We treated the participants as the unit of analysis in standard RCTs. For studies with non‐standard designs, such as cluster‐randomized trials or multi‐arm studies, we handled the data in accordance with the guidelines in Chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022).
Dealing with missing data
We contacted the investigators or study sponsors to verify the key study information and request missing outcome data where possible. If feasible, we used the Review Manager Web calculator to calculate missing SDs using other data from the trial, such as CIs (RevMan Web 2022). Where this was not feasible, and the missing data were thought to be a source of serious bias, we would detect the impact of including such studies in the overall assessment of results by a sensitivity analysis.
Assessment of heterogeneity
We used the I2 statistic to measure heterogeneity among the trials in each analysis. We considered an I2 value of 60% or more as an indicator of moderate to substantial levels of heterogeneity. If heterogeneity existed, we would try to explore potential sources by subgroup characteristics, meta‐regression, or sensitivity analyses. However, if we found substantial heterogeneity (80% or more) that was not explained by the above analyses, we would provide a narrative description of the result rather than report meta‐analysis. We would develop the descriptive statistic for potential effect modifiers described above such as study, population, and intervention characteristics from all eligible trials that compared each pair of interventions.
Assessment of reporting biases
We would use funnel plots to assess potential reporting bias if there were 10 or more included studies in the review, as recommended in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022). If there were fewer than 10 included studies, we would instead assess reporting bias qualitatively based on the characteristics of the included studies.
Data synthesis
If there were at least two studies eligible for inclusion, we would conduct a meta‐analysis on the outcomes. If an insufficient number of studies precluded meta‐analysis, we would provide a narrative summary of the study results. Where we considered included studies to be sufficiently similar, we performed standard pairwise meta‐analyses by pooling data using Review Manager Web (RevMan Web 2022). We used the Bayesian random‐effects model to obtain summary effect measures with 95% CIs (Sutton 2001). We used the normal distribution in the vague priors for all trial baselines, treatment effects, and between‐study SD.
Subgroup analysis and investigation of heterogeneity
If possible we would carry out subgroup analyses for the primary outcome by:
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ethnicity (e.g. Asian versus white versus African versus Hispanic people);
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age range of included participants;
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time window from symptom onset (e.g. less than six hours versus six hours or more); and
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lesion location (i.e. intracranial artery, middle cerebral artery, basilar artery versus vertebral artery).
We would test subgroup differences using ‘test for subgroup differences’ in Review Manager Web (RevMan Web 2022), and base our interpretation on this.
Sensitivity analysis
When I2 ≥ 60%, we would conduct a sensitivity analysis on the primary outcome by excluding studies:
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with inadequate allocation concealment;
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where outcome assessment was not blinded;
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that were unpublished;
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where loss to follow‐up was not reported, or was more than 10%; and
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where the funder played an important role that may affect the primary outcome.
In addition, we would conduct a sensitivity analysis that included only trials that compared one endovascular approach with another.
Summary of findings and assessment of the certainty of the evidence
We created a summary of findings table using the following outcomes: functional independence at three months (mRS 0 to 2), successful reperfusion (mTICI 2b to 3) postprocedure, mortality from any cause within three months, ICH on imaging at 24 hours, symptomatic ICH at 24 hours, and procedure‐related adverse events within three months. We assessed the overall quality of the evidence for each outcome in accordance with the GRADE approach. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of the body of evidence as it relates to the studies that contribute data to the meta‐analyses for the prespecified outcomes (Atkins 2004). Two review authors independently used the methods and recommendations in Chapter 14 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022), employing GRADEpro GDT software to rank the quality of evidence for each outcome as high, moderate, low, or very low (GRADEpro GDT). Any differences were resolved by consensus or by involving a third review author. We justified all decisions to downgrade the quality of the evidence using footnotes, and made comments to aid the reader's understanding of the review where necessary. If it was not possible to perform meta‐analysis, we would exhibit results in a narrative summary of findings table format.
Results
Description of studies
See Included studies, Excluded studies, and Ongoing studies.
Results of the search
We screened a total of 30,955 records after removing 7835 duplicates. We excluded 30,948 references based on title and abstract. We identified four included studies and one ongoing study after full‐text review. The two excluded studies were ineligible because of the intervention type. The PRISMA flow diagram is shown in Figure 1.
Included studies
We included four studies involving a total of 1254 participants. All the studies were multicenter, prospective, randomized, open‐label, blinded end‐point clinical trials.
All participants presenting with acute ischemic stroke from large vessel occlusion had imaging evidence. The included trials involved only adults, of which the average age ranged from 66.9 to 73.6 years. The sex ratio was close to 1 (male participants accounted for 48.2%). A total of 527 participants received stent retriever first‐line treatment; 426 received aspiration thrombectomy; and 301 received thrombo‐aspiration and stent retriever combined treatment.
Lapergue 2017 and Turk 2019 reported the comparison of stent retriever group versus thrombo‐aspiration group for ischemic stroke secondary to occlusion of the anterior circulation including intracranial internal carotid artery, and middle cerebral artery within six hours of onset of symptoms. Lapergue 2021 compared stent retriever alone versus aspiration‐retriever combined technique for large vessel occlusions in the anterior circulation, within eight hours of symptom onset. Nogueira 2018 compared thrombo‐aspiration alone versus thrombo‐aspiration and stent retriever combined for large vessel occlusions including internal carotid artery, middle cerebral artery, intracranial vertebral artery, and basilar artery within eight hours of symptom onset. Given the different treatments in the included studies, we performed meta‐analysis only for the comparison of aspiration versus stent retriever.
Regarding the safety outcomes, study endpoints were similar in the four studies. We were able to collect and analyze detailed data of procedure‐related adverse events, new ischemic area or ICH within 24 hours, and all‐cause mortality at 90 days. For efficacy outcomes, we analyzed postprocedure mTICI score and mRS score at 90 days for the three different comparisons.
Excluded studies
We excluded two completed trials comparing the effect and safety of two stent retrievers rather than another type of mechanical thrombectomy (Cao 2020; Zhou 2022).
Risk of bias in included studies
Risk of bias assessment is shown in the risk of bias tables in each analysis respectively and was judged as low in all studied domains.
Effects of interventions
Primary outcomes
Rate of functional independence at three months: modified Rankin Scale (mRS) of 0 to 2
Meta‐analysis showed there was no significant difference in rate of functional independence at three months between the thrombo‐aspiration group and stent‐retrieval thrombectomy group, with no heterogeneity (risk ratio [RR] 0.97, 95% confidence interval [CI] 0.82 to 1.13; P = 0.68; 633 participants; 2 RCTs; I2 = 0%; high‐certainty evidence; Analysis 1.1). Similar results were also shown for the comparison of stent‐retriever versus combined treatment according to Nogueira 2018 (RR 1.09, 95% CI 1.01 to 1.19; P = 0.95). There were no significant difference in rate of functional independence among aspiration, stent retriever, and the combined treatment.
Secondary outcomes
Rate of successful reperfusion
Comparing thrombo‐aspiration with stent retriever for the reperfusion outcome, the rate of mTICI of 2b to 3 did not differ between groups (RR 1.01, 95% CI 0.95 to 1.07; P = 0.77; I2 = 0%; high‐certainty evidence; Analysis 1.2). The analysis of Nogueira 2018 showed the aspiration‐retriever combination had the same rate of successful reperfusion as aspiration alone (RR 1.00, 95% CI 0.95 to 1.06; P = 0.98). Moreover, one trial with 405 participants assessed the reperfusion rate by expanded TICI rather than the modified methods, for which the reperfusion results were similar postprocedure (RR 0.90, 95% CI 0.77 to 1.05; P = 0.17) (Lapergue 2021).
All‐cause mortality within three months
Lapergue 2017 and Turk 2019 (n = 633) reported the mortality rate within three months as 65/315 in the aspiration group and 65/318 in the stent retriever group, for all causes (RR 1.01, 95% CI 0.74 to 1.37; P = 0.95; I2 = 0%; high‐certainty evidence; Analysis 1.3). Data from the other two RCTs were also available. Lapergue 2021 showed a similar short‐term mortality rate for stent retriever alone compared to aspiration‐retriever combined group (RR 0.99, 95% CI 0.71 to 1.39; P = 0.95). Furthermore, there was no significant difference in all‐cause mortality for the comparison of aspiration alone versus the combined treatment (RR 1.34, 95% CI 0.80 to 2.26; P = 0.27).
Rate of intracranial hemorrhage on imaging at 24 hours
Intracranial hemorrhage at 24 hours postprocedure of all types, such as intracerebral, subarachnoid, and intraventricular hemorrhages, was assessed as a safety outcome. There were no differences between the aspiration group and the stent retriever group in rate of ICH on imaging at 24 hours (RR 1.03, 95% CI 0.86 to 1.24; P = 0.73; I2 = 0%; high‐certainty evidence; Analysis 1.4). There was also no difference between stent‐retrieval thrombectomy alone and the combined treatment (RR 1.03, 95% CI 0.84 to 1.26, P = 0.76). However, data from Nogueira 2018 were not available for the analysis of total ICH events.
Rate of symptomatic intracranial hemorrhage at 24 hours
We further analyzed the rate of symptomatic ICH according to these included trials (Lapergue 2017; Turk 2019). The rate of symptomatic ICH was similar between the aspiration and stent retriever groups (RR 0.90, 95% CI 0.49 to 1.68; P = 0.75; high‐certainty evidence; Analysis 1.5); between the stent retriever alone and the combined groups (RR 1.22, 95% CI 0.60 to 2.46; P = 0.58); and between the aspiration alone and the combined groups (RR 1.63, 95% CI 0.40 to 6.65; P = 0.49).
Rate of procedure‐related adverse events within three months
We analyzed the rate of procedure‐related adverse events within three months for safety assessment, mainly including subarachnoid hemorrhage, new cerebral infarction, arterial dissection, and arterial perforation. Meta‐analysis showed similar risks of procedure‐related adverse events occurring in 651 participants treated by thrombo‐aspiration or stent‐retriever in the Lapergue 2017 and Turk 2019 studies (RR 0.98, 95% CI 0.68 to 1.41; P = 0.90; I2 = 0%; high‐certainty evidence; Analysis 1.6). Likewise, procedure‐related adverse events were reported in 49/202 participants in the stent retriever alone group and 51/203 in the combined group (RR 0.97, 95% CI 0.69 to 1.36; P = 0.84; Lapergue 2021). No significant differences were noted in Nogueira 2018 in terms of procedure‐related (RR 1.37, 95% CI 0.64 to 2.94; P = 0.42), as well as device‐related adverse events (RR 1.23, 95% CI 0.34 to 4.43; P = 0.76) within three months.
Discussion
Summary of main results
This systematic review included four RCTs with 1254 adult participants who had a clinical diagnosis of acute ischemic stroke due to large vessel occlusion and confirmed by imaging evidence. Two trials compared thrombo‐aspiration with stent‐retrieval thrombectomy; one trial compared aspiration with aspiration‐retriever combined technique; and one trial compared stent‐retriever with aspiration‐retriever combined technique. The latter two trials showed similar safety and efficacy outcomes for the comparisons of combined treatment with sole thrombo‐aspiration or stent‐retriever. We found no significant differences between aspiration and stent‐retrieval thrombectomy in three‐month functional independence, all‐cause mortality, and procedure‐related adverse events. The quality of the evidence for all outcomes assessed by GRADE was high (GRADEpro GDT).
Overall completeness and applicability of evidence
The quality of evidence in this review was high, and the estimated effect was solid based on current research. A major limitation of the review was the limited number trials that could be included for meta‐analysis for the comparisons of aspiration‐retriever combined technique with any other treatment alone. However, the rapid development of techniques and updated equipment may greatly influence the efficacy and safety of different types of thrombectomy.
Quality of the evidence
We judged the quality of evidence according to the GRADE approach. Although the operators could not be blinded to the interventions, we did not judge this to be a risk of bias for the outcomes reported. We evaluated the quality of the evidence in the review to be high with respect to risk of bias, inconsistency, imprecision, and publication bias, and our results to therefore be convincing.
Potential biases in the review process
We attempted to minimize bias during the review process by having two review authors independently identify eligible studies and extract data. A third review author was consulted to resolve any disputes during the process. We also consulted Cochrane statisticians when necessary. We did not perform a funnel‐plot analysis because we only included four eligible trials.
Agreements and disagreements with other studies or reviews
There have been a number of meta‐analyses reviewing the different types of thrombectomy. The majority of them included RCTs, case‐control, and cohort studies. Three previous studies suggested that the aspiration‐retriever combined technique is comparably safe and effective with stent‐retrieval thrombectomy in achieving good clinical outcomes, which was similar with our findings (Boulanger 2019; Primiani 2019; Zhang 2021). However, Tsang 2018 and Texakalidis 2020 indicated higher mTICI 2b/3 and mTICI 3 recanalization rates with stent‐retrieval thrombectomy and combined treatment compared to thrombo‐aspiration. Additionally, a review focusing on posterior circulation found that the thrombo‐aspiration group achieved a significantly higher reperfusion rate (odds ratio 1.97, 95% CI 1.03 to 3.76) than the stent‐retrieval group and required fewer rescue treatments (21.5% versus 29.6%, P < 0.05) (Zhang 2020). Moreover, the rate of first pass effect was 40.8% and 32.6% for combined therapy and stent‐retrieval thrombectomy, respectively. Most of the reviews mentioned here were limited by higher interstudy heterogeneity and lower‐quality evidence. Furthermore, improvements in stent‐retriever and aspiration thrombectomy techniques may greatly change the outcomes of different types of percutaneous endovascular interventions in AIS, therefore more RCTs with high‐level evidence focusing on updated equipment are expected in future research.
Study flow diagram.
Comparison 1: Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke, Outcome 1: mRS score of 0 to 2 at 3 months (primary outcome)
Comparison 1: Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke, Outcome 2: mTICI 2b/3 postprocedure
Comparison 1: Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke, Outcome 3: All‐cause mortality at 3 months
Comparison 1: Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke, Outcome 4: Intracranial hemorrhage on imaging at 24 hours
Comparison 1: Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke, Outcome 5: Symptomatic intracranial hemorrhage at 24 hours
Comparison 1: Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke, Outcome 6: Procedure‐related serious adverse events at 3 months
| Thrombo‐aspiration versus stent‐retrieval thrombectomy for acute ischemic stroke | |||||
| Patient or population: people with acute ischemic stroke Settings: hospital Intervention: stent‐retrieval thrombectomy Comparison: thrombo‐aspiration | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No. of participants | Quality of the evidence | |
|---|---|---|---|---|---|
| Risk with thrombo‐aspiration | Risk with stent‐retrieval thrombectomy | ||||
| Functional independence at 3 months (mRS 0 to 2) (primary outcome) | 497 per 1000 (408 to 562) | 482 per 1000
| RR 0.97 (0.82 to 1.13) | 633 | ⊕⊕⊕⊕ |
| Successful reperfusion (mTICI 2b to 3) postprocedure | 874 per 1000 (776 to 881) | 883 per 1000 | RR 1.01 (0.95 to 1.07) | 650 | ⊕⊕⊕⊕ |
| All‐cause mortality within 3 months | 204 per 1000 (151 to 280) | 206 per 1000
| RR 1.01 (0.74 to 1.37) | 633 | ⊕⊕⊕⊕ |
| Intracranial hemorrhage on imaging at 24 hours | 406 per 1000 (349 to 503) | 418 per 1000
| RR 1.03 (0.86 to 1.24) | 645 | ⊕⊕⊕⊕ |
| Symptomatic intracranial hemorrhage at 24 hours | 62 per 1000 (30 to 104) | 56 per 1000
| RR 0.9 (0.49 to 1.68) | 645 | ⊕⊕⊕⊕ |
| Procedure‐related adverse events within 3 months | 151 per 1000 (103 to 213) | 148 per 1000
| RR 0.98 (0.68 to 1.41) | 651 | ⊕⊕⊕⊕ |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; mRS: modified Rankin Scale; mTICI: modified Thrombolysis In Cerebral Infarction; RCT: randomized controlled trial; RR: risk ratio | |||||
| GRADE Working Group grades of evidence | |||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 mRS score of 0 to 2 at 3 months (primary outcome) Show forest plot | 2 | 633 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.82, 1.13] |
| 1.2 mTICI 2b/3 postprocedure Show forest plot | 2 | 650 | Risk Ratio (M‐H, Random, 95% CI) | 1.01 [0.95, 1.07] |
| 1.3 All‐cause mortality at 3 months Show forest plot | 2 | 633 | Risk Ratio (M‐H, Random, 95% CI) | 1.01 [0.74, 1.37] |
| 1.4 Intracranial hemorrhage on imaging at 24 hours Show forest plot | 2 | 645 | Risk Ratio (M‐H, Random, 95% CI) | 1.03 [0.86, 1.24] |
| 1.5 Symptomatic intracranial hemorrhage at 24 hours Show forest plot | 2 | 645 | Risk Ratio (M‐H, Random, 95% CI) | 0.90 [0.49, 1.68] |
| 1.6 Procedure‐related serious adverse events at 3 months Show forest plot | 2 | 651 | Risk Ratio (M‐H, Random, 95% CI) | 0.98 [0.68, 1.41] |
| Bias | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | ||||||
| Lapergue 2017 |  | | | | | | ||||||
| Quote: “A dynamic randomisation procedure using the Pocock and Simon minimization method was used to achieve a balance of the following factors related to the final eTICI score at the end of the endovascular procedure...” | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no deviations were suggested because of the trial context. | ||||||||||||
| The rate of loss to 1‐year follow‐up is more than 10% (50/405). But no evidence showed that result was biased by missing outcome data. | ||||||||||||
| Quote: "All neuroimaging readings including determination of site of arterial occlusion, clot burden score, and hemorrhagic transformation were performed at the imaging core laboratory and blinded to procedure allocation. Serious adverse events and procedure‐related complications were adjudicated by 3 members of the data and safety monitoring board blinded to treatment group. The 90‐day mRS score was assessed by trained research nurses unaware of the group assignments during face‐to‐face interviews or via telephone conversations. The NIHSS score at 24 hours was assessed by the treating physician, who was not blinded to the group assignments." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Turk 2019 | | | | | | | ||||||
| Quote: "...by a central web‐based system to treatment with either a direct aspiration as first pass thrombectomy or stent retriever as first line thrombectomy." | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments. | ||||||||||||
| The rate of loss is less than 10%. | ||||||||||||
| Quote: "All staff performing clinical examinations were certified assessors who were not involved in the study procedures. In addition, 90‐day modified Rankin Scale assessors were required to be masked to the method of treatment. Masking was achieved by ensuring that 90‐day assessors were not aware of the patient’s randomisation assignment and did not have access to the electronic data capture system." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Bias | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | ||||||
| Lapergue 2017 | | | | | | | ||||||
| Quote: “A dynamic randomisation procedure using the Pocock and Simon minimization method was used to achieve a balance of the following factors related to the final eTICI score at the end of the endovascular procedure...” | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments, and the related analysis was appropriate. | ||||||||||||
| The rate of loss to 1‐year follow‐up is more than 10% (50/405). But no evidence showed that result was biased by missing outcome data. | ||||||||||||
| The measurement seemed to be appropriate. Quote: "All neuroimaging readings including determination of site of arterial occlusion, clot burden score, and hemorrhagic transformation were performed at the imaging core laboratory and blinded to procedure allocation. Serious adverse events and procedure‐related complications were adjudicated by 3 members of the data and safety monitoring board blinded to treatment group. The 90‐day mRS score was assessed by trained research nurses unaware of the group assignments during face‐to‐face interviews or via telephone conversations. The NIHSS score at 24 hours was assessed by the treating physician, who was not blinded to the group assignments." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Turk 2019 | | | | | | | ||||||
| Quote: "...by a central web‐based system to treatment with either a direct aspiration as first pass thrombectomy or stent retriever as first line thrombectomy." | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments, and the related analysis was appropriate. | ||||||||||||
| The rate of loss is less than 10%. | ||||||||||||
| The measurement was appropriate according to the context. | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Bias | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | ||||||
| Lapergue 2017 | | | | | | | ||||||
| Quote: “A dynamic randomisation procedure using the Pocock and Simon minimization method was used to achieve a balance of the following factors related to the final eTICI score at the end of the endovascular procedure...” | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments, and the analysis was appropriate. | ||||||||||||
| The rate of loss to 1‐year follow‐up is more than 10% (50/405). But no evidence showed that result was biased by missing outcome data. | ||||||||||||
| The measurement was appropriate according to the context. Quote: "All neuroimaging readings including determination of site of arterial occlusion, clot burden score, and hemorrhagic transformation were performed at the imaging core laboratory and blinded to procedure allocation. Serious adverse events and procedure‐related complications were adjudicated by 3 members of the data and safety monitoring board blinded to treatment group. The 90‐day mRS score was assessed by trained research nurses unaware of the group assignments during face‐to‐face interviews or via telephone conversations. The NIHSS score at 24 hours was assessed by the treating physician, who was not blinded to the group assignments." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Turk 2019 | | | | | | | ||||||
| Quote: "...by a central web‐based system to treatment with either a direct aspiration as first pass thrombectomy or stent retriever as first line thrombectomy." | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments. | ||||||||||||
| The rate of loss is less than 10%. | ||||||||||||
| The measurement was appropriate according to the context. Quote: "All staff performing clinical examinations were certified assessors who were not involved in the study procedures. In addition, 90‐day modified Rankin Scale assessors were required to be masked to the method of treatment. Masking was achieved by ensuring that 90‐day assessors were not aware of the patient’s randomisation assignment and did not have access to the electronic data capture system." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Bias | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | ||||||
| Lapergue 2017 | | | | | | | ||||||
| Quote: “A dynamic randomisation procedure using the Pocock and Simon minimization method was used to achieve a balance of the following factors related to the final eTICI score at the end of the endovascular procedure...” | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no deviations were suggested because of the trial context. | ||||||||||||
| The rate of loss to 1‐year follow‐up is more than 10% (50/405). But no evidence showed that result was biased by missing outcome data. | ||||||||||||
| The measurement seemed to be appropriate. Quote: "All neuroimaging readings including determination of site of arterial occlusion, clot burden score, and hemorrhagic transformation were performed at the imaging core laboratory and blinded to procedure allocation. Serious adverse events and procedure‐related complications were adjudicated by 3 members of the data and safety monitoring board blinded to treatment group. The 90‐day mRS score was assessed by trained research nurses unaware of the group assignments during face‐to‐face interviews or via telephone conversations. The NIHSS score at 24 hours was assessed by the treating physician, who was not blinded to the group assignments." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Turk 2019 | | | | | | | ||||||
| Quote: "...by a central web‐based system to treatment with either a direct aspiration as first pass thrombectomy or stent retriever as first line thrombectomy." | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments. | ||||||||||||
| The rate of loss is less than 10%. | ||||||||||||
| The measurement was appropriate according to the context. Quote: "All staff performing clinical examinations were certified assessors who were not involved in the study procedures. In addition, 90‐day modified Rankin Scale assessors were required to be masked to the method of treatment. Masking was achieved by ensuring that 90‐day assessors were not aware of the patient’s randomisation assignment and did not have access to the electronic data capture system." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Bias | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | ||||||
| Lapergue 2017 | | | | | | | ||||||
| Quote: “A dynamic randomisation procedure using the Pocock and Simon minimization method was used to achieve a balance of the following factors related to the final eTICI score at the end of the endovascular procedure...” | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no deviations were suggested because of the trial context. | ||||||||||||
| The rate of loss to 1‐year follow‐up is more than 10% (50/405). But no evidence showed that result was biased by missing outcome data. | ||||||||||||
| The measurement seemed to be appropriate. Quote: "All neuroimaging readings including determination of site of arterial occlusion, clot burden score, and hemorrhagic transformation were performed at the imaging core laboratory and blinded to procedure allocation. Serious adverse events and procedure‐related complications were adjudicated by 3 members of the data and safety monitoring board blinded to treatment group. The 90‐day mRS score was assessed by trained research nurses unaware of the group assignments during face‐to‐face interviews or via telephone conversations. The NIHSS score at 24 hours was assessed by the treating physician, who was not blinded to the group assignments." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Turk 2019 | | | | | | | ||||||
| Quote: "...by a central web‐based system to treatment with either a direct aspiration as first pass thrombectomy or stent retriever as first line thrombectomy." | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments. | ||||||||||||
| The rate of loss is less than 10%. | ||||||||||||
| The measurement was appropriate according to the context. Quote: "All staff performing clinical examinations were certified assessors who were not involved in the study procedures. In addition, 90‐day modified Rankin Scale assessors were required to be masked to the method of treatment. Masking was achieved by ensuring that 90‐day assessors were not aware of the patient’s randomisation assignment and did not have access to the electronic data capture system." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Bias | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | ||||||
| Lapergue 2017 | | | | | | | ||||||
| Quote: “A dynamic randomisation procedure using the Pocock and Simon minimization method was used to achieve a balance of the following factors related to the final eTICI score at the end of the endovascular procedure...” | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no deviations were suggested because of the trial context. | ||||||||||||
| The rate of loss to 1‐year follow‐up is more than 10% (50/405). But no evidence showed that result was biased by missing outcome data. | ||||||||||||
| The measurement seemed to be appropriate. Quote: "All neuroimaging readings including determination of site of arterial occlusion, clot burden score, and hemorrhagic transformation were performed at the imaging core laboratory and blinded to procedure allocation. Serious adverse events and procedure‐related complications were adjudicated by 3 members of the data and safety monitoring board blinded to treatment group. The 90‐day mRS score was assessed by trained research nurses unaware of the group assignments during face‐to‐face interviews or via telephone conversations. The NIHSS score at 24 hours was assessed by the treating physician, who was not blinded to the group assignments." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
| Turk 2019 | | | | | | | ||||||
| Quote: "...by a central web‐based system to treatment with either a direct aspiration as first pass thrombectomy or stent retriever as first line thrombectomy." | ||||||||||||
| It's an open‐label clinical trial. Intervention is different which could be identified. However, no differences were reported because of treatments. | ||||||||||||
| The rate of loss is less than 10%. | ||||||||||||
| The measurement was appropriate according to the context. Quote: "All staff performing clinical examinations were certified assessors who were not involved in the study procedures. In addition, 90‐day modified Rankin Scale assessors were required to be masked to the method of treatment. Masking was achieved by ensuring that 90‐day assessors were not aware of the patient’s randomisation assignment and did not have access to the electronic data capture system." | ||||||||||||
| All of the study's outcomes were prespecified in the registered information. | ||||||||||||
| Overall bias were low according to ROB2. | ||||||||||||
