Summary Background The Solitaire Flow Restoration Device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. We compared the efficacy and ...safety of Solitaire with the standard, predicate mechanical thrombectomy device, the Merci Retrieval System. Methods In this randomised, parallel-group, non-inferiority trial, we enrolled patients from 18 sites (17 in the USA and one in France). Patients were eligible for inclusion if they had acute ischaemic stroke with moderate to severe neurological deficits and were treatable by thrombectomy within 8 h of stroke symptom onset. We used a computer-generated randomisation sequence to randomly allocate patients to receive thrombectomy treatment with either Solitaire or Merci (1:1; block sizes of four and stratified by centre and stroke severity). The primary endpoint was Thrombolysis In Myocardial Ischemia (TIMI) scale 2 or 3 flow in all treatable vessels without symptomatic intracranial haemorrhage, after up to three passes of the assigned device, as assessed by an independent core laboratory, which was masked to study assignment. Primary analysis was done by intention to treat. A prespecified efficacy stopping rule triggered an early halt to the trial. The study is registered with ClinicalTrials.gov , number NCT 01054560. Results Between February, 2010, and February, 2011, we randomly allocated 58 patients to the Solitaire group and 55 patients to the Merci group. The primary efficacy outcome was achieved more often in the Solitaire group than it was in the Merci group (61% vs 24%; difference 37% 95% CI 19–53, odds ratio OR 4·87 95% CI 2·14–11·10; pnon-inferiority <0·0001, psuperiority =0·0001). More patients had good 3-month neurological outcome with Solitaire than with Merci (58% vs 33%; difference 25% 6–43, OR 2·78 1·25–6·22; pnon-inferiority =0·0001, psuperiority =0·02). 90-day mortality was lower in the Solitaire group than it was in the Merci group (17 vs 38; difference −21% –39 to −3, OR 0·34 0·14–0·81; pnon-inferiority =0·0001, psuperiority =0·02). Interpretation The Solitaire Flow Restoration Device achieved substantially better angiographic, safety, and clinical outcomes than did the Merci Retrieval System. The Solitaire device might be a future treatment of choice for endovascular recanalisation in acute ischaemic stroke. Funding Covidien/ev3.
Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited.
We conducted a multicenter, prospective, ...randomized, controlled trial of endovascular thrombectomy for basilar-artery occlusion at 36 centers in China. Patients were assigned, in a 2:1 ratio, within 12 hours after the estimated time of basilar-artery occlusion to receive endovascular thrombectomy or best medical care (control). The primary outcome was good functional status, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 no symptoms to 6 death), at 90 days. Secondary outcomes included a modified Rankin scale score of 0 to 2, distribution across the modified Rankin scale score categories, and quality of life. Safety outcomes included symptomatic intracranial hemorrhage at 24 to 72 hours, 90-day mortality, and procedural complications.
Of the 507 patients who underwent screening, 340 were in the intention-to-treat population, with 226 assigned to the thrombectomy group and 114 to the control group. Intravenous thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of those in the control group. Good functional status at 90 days occurred in 104 patients (46%) in the thrombectomy group and in 26 (23%) in the control group (adjusted rate ratio, 2.06; 95% confidence interval CI, 1.46 to 2.91, P<0.001). Symptomatic intracranial hemorrhage occurred in 12 patients (5%) in the thrombectomy group and in none in the control group. Results for the secondary clinical and imaging outcomes were generally in the same direction as those for the primary outcome. Mortality at 90 days was 37% in the thrombectomy group and 55% in the control group (adjusted risk ratio, 0.66; 95% CI, 0.52 to 0.82). Procedural complications occurred in 14% of the patients in the thrombectomy group, including one death due to arterial perforation.
In a trial involving Chinese patients with basilar-artery occlusion, approximately one third of whom received intravenous thrombolysis, endovascular thrombectomy within 12 hours after stroke onset led to better functional outcomes at 90 days than best medical care but was associated with procedural complications and intracerebral hemorrhage. (Funded by the Program for Innovative Research Team of the First Affiliated Hospital of USTC and others; ATTENTION ClinicalTrials.gov number, NCT04751708.).
Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly ...assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis.
We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days.
Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years SD 13·7, 259 51·3% women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 45·9% of 266 vs 46 19·3% of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 16·5% of 266 vs 46 19·3% of 238) or symptomatic intracerebral haemorrhage (14 5·3% of 266 vs eight 3·3% of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 95% CI 3·14–10·94) than those randomly assigned within 6–12 h (1·76 1·18–2·62; pinteraction=0·0087).
These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window.
Stryker Neurovascular.
Summary Background Present mechanical devices are unable to achieve recanalisation in up to 20–40% of large vessel occlusion strokes. We compared efficacy and safety of the Trevo Retriever, a new ...stent-like device, with its US Food and Drug Administration-cleared predecessor, the Merci Retriever. Methods In this open-label randomised controlled trial, we recruited patients at 26 sites in the USA and one in Spain. We included adults aged 18–85 years with angiographically confirmed large vessel occlusion strokes and US National Institutes of Health Stroke Scale (NIHSS) scores of 8–29 within 8 h of symptom onset. We randomly assigned patients (1:1) with sequentially numbered sealed envelopes to thrombectomy with Trevo or Merci devices. Randomisation was stratified by age (≤68 years vs 69–85 years) and NIHSS scores (≤18 vs 19–29) with alternating blocks of various sizes. The primary efficacy endpoint, assessed by an unmasked core laboratory, was thrombolysis in cerebral infarction (TICI) scores of 2 or greater reperfusion with the assigned device alone. The primary safety endpoint was a composite of procedure-related adverse events. Analyses were done by intention to treat. This study is registered with ClinicalTrials.gov , number NCT01270867. Findings Between Feb 3, 2011, and Dec 1, 2011, we randomly assigned 88 patients to the Trevo Retriever group and 90 patients to Merci Retriever group. 76 (86%) patients in the Trevo group and 54 (60%) in the Merci group met the primary endpoint after the assigned device was used (odds ratio 4·22, 95% CI 1·92–9·69; psuperiority <0·0001). Incidence of the primary safety endpoint did not differ between groups (13 15% patients in the Trevo group vs 21 23% in the Merci group; p=0·1826). Interpretation Patients who have had large vessel occlusion strokes but are ineligible for (or refractory to) intravenous tissue plasminogen activator should be treated with the Trevo Retriever in preference to the Merci Retriever. Funding Stryker Neurovascular.
A succession of research has explored the linkage between carotid webs (CaWs) and ischemic strokes. Imaging and pathologic analysis have defined CaW as an intimal variant of fibromuscular dysplasia, ...which appears as a shelflike lesion on the posterior aspect of the carotid bulb, more specifically at the origin of internal carotid artery. Reported findings of carotid webs in young patients with recurrent ischemic strokes without an otherwise determined cause have raised questions about the mechanism, natural history, and need for intervention. This review addresses the current understanding of CaW and highlights findings that prompt further investigation into this unique vascular entity as a modifiable stroke risk factor.
Imaging analysis demonstrates hemodynamic disturbance in the presence of CaWs. The protuberant shelflike structure creates a pocket therein that may subsequently lead to local thrombosis and cerebral embolism. Computed tomographic angiography is an accurate and often used noninvasive diagnostic modality. Although treatment paradigms have not been systematically evaluated, antiplatelet monotherapy may not be sufficient to reduce recurrent ischemic events in the small series of patients with stroke and symptomatic CaWs.
The limited clinical data on CaWs, although complicated by selection bias, suggest an increased prevalence of these vascular entities in cerebral ischemic events among patients younger than 60 years. Imaging suggests CaW to be a possible nidus for cerebral thromboembolism. Physicians should consider CaW as a cause of stroke in younger patients with anterior circulation ischemic strokes of an otherwise undetermined cause. Treatment options in CaWs with ischemic strokes have not been extensively investigated. Multicenter observational studies evaluating the natural history of CaW are warranted.
Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue ...plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome.
We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 no symptoms to 6 death).
The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12).
In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).
Carotid webs have been increasingly recognized as a cause of recurrent stroke, but evidence remains scarce. We aim to report the clinical outcomes and first series of carotid stenting in a cohort of ...patients with strokes from symptomatic carotid webs.
Prospective and consecutive data of patients <65 years old with cryptogenic stroke admitted within September 2014 to May 2017. Carotid web was defined by a shelf-like/linear filling defect in the posterior internal carotid artery bulb by computed tomographic angiography.
Twenty-four patients were identified (91.6% strokes/8.4% transient ischemic attacks TIAs). Median age was 46 (41-59) years, 61% were female, and 75% were black. Median National Institutes of Health Stroke Scale score was 10.5 (3.0-16.0) and ASPECTS (Alberta Stroke Program Early CT Score) was 8 (7-8). There were no parenchymal hemorrhages, and 96% of patients were independent at 3 months. All webs caused <50% stenosis. In patients with bilateral webs (58%), median ipsilateral web length was larger than contralateral (3.1 3.0-4.5 mm versus 2.6 1.85-2.9 mm;
=0.01), respectively. Twenty-nine percent of patients had thrombus superimposed on the symptomatic carotid web. A recurrent stroke/TIA involving the territory of the previously symptomatic web occurred in 7 (32%; 6 strokes/1 TIA) patients: 3 <1 week, 2 <first year, and 3 >1 year of follow-up. Two recurrences occurred on dual antiplatelet therapy, 3 on antiplatelet monotherapy, 1 within 24 hours of thrombolysis, and 1 off antithrombotics. Median follow-up was 12.2 (8.0-18.0) months. Sixteen (66%) patients were stented at a median 12.2 (7.0-18.7) days after stroke with no periprocedural complications. No recurrent strokes/TIAs occurred in stented individuals (median follow-up of 4 2.4-12.0 months).
Carotid web is associated with high recurrent stroke/TIA risk, despite antithrombotic use, and is amenable to carotid stenting.
Reversible cerebral vasoconstriction syndromes (RCVS) and primary angiitis of the central nervous system (PACNS) are invariably considered in the differential diagnosis of new cerebral ...arteriopathies. However, prompt and accurate diagnosis remains challenging. Here we compared the features of 159 RCVS to 47 PACNS patients and developed criteria for prompt bedside diagnosis. Recurrent thunderclap headache (TCH), and single TCH combined with either normal neuroimaging, border zone infarcts, or vasogenic edema, have 100% positive predictive value for diagnosing RCVS or RCVS‐spectrum disorders. In patients without TCH and positive angiography, neuroimaging can discriminate RCVS (no lesion) from PACNS (deep/brainstem infarcts). Ann Neurol 2016;79:882–894
Endovascular treatment is a highly effective therapy for acute ischemic stroke due to large vessel occlusion and has recently revolutionized stroke care. Oftentimes, ischemic core extent on baseline ...imaging is used to determine endovascular treatment-eligibility. There are, however, 3 fundamental issues with the core concept: First, computed tomography and magnetic resonance imaging, which are mostly used in the acute stroke setting, are not able to precisely determine whether and to what extent brain tissue is infarcted (core) or still viable, due to variability in tissue vulnerability, the phenomenon of selective neuronal loss and lack of a reliable gold standard. Second, treatment decision-making in acute stroke is multifactorial, and as such, the relative importance of single variables, including imaging factors, is reduced. Third, there are often discrepancies between core volume and clinical outcome. This review will address the uncertainty in terminology and proposes a direction towards more clarity. This theoretical exercise needs empirical data that clarify the definitions further and prove its value.
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