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Mechanical thrombectomy for emergent large vessel occlusion: a critical appraisal of recent randomized controlled clinical trials.

ABSTRACT: BACKGROUND AND PURPOSE:After numerous attempts to prove efficacy for endovascular treatment of ischemic stroke, a series of recent randomized controlled clinical trials (RCTs) established fast mechanical thrombectomy (MT) as a safe and effective novel treatment for emergent large vessel occlusion (ELVO) in the anterior cerebral circulation. METHODS:We reviewed five recent RCTs that evaluated the safety and efficacy of MT in ELVO patients and captured available information on recanalization/reperfusion, symptomatic intracranial hemorrhage (sICH), clinical outcome, and mortality. MT was performed with stent retrievers, aspiration techniques, or a combination of these endovascular approaches. We applied meta-analytical methodology to evaluate the pooled effect of MT on recanalization/reperfusion, sICH, functional independence (modified Rankin scale score of 0-2) and 3-month mortality rates in comparison to best medical therapy (BMT). RESULTS:MT was associated with increased likelihood of complete recanalization/reperfusion (RR: 2.22; 95%CI: 1.89-2.62; P < 0.00001) and 3-month functional independence (RR: 1.72; 95%CI: 1.48-1.99; P < 0.00001) without any heterogeneity across trials (I (2) = 0%). The absolute benefit increase in MT for complete recanalization/reperfusion and functional independence was 44 (NNT = 2) and 16 (NNT = 6), respectively. MT was not associated with increased risk of 3-month mortality (15% with MT vs. 19% with BMT) and sICH (4.6% with MT vs. 4.3% with BMT), while small heterogeneity was detected across the included trials (I (2) < 25%). CONCLUSIONS:MT is a safe and highly effective treatment for patients with ELVO in the anterior circulation. For every six ELVO patients treated with MT three more will achieve complete recanalization at 24 h following symptom onset and one more will be functionally independent at 3 months in comparison to BMT.

SUBMITTER: Tsivgoulis G

PROVIDER: S-EPMC4834930 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Mechanical thrombectomy for emergent large vessel occlusion: a critical appraisal of recent randomized controlled clinical trials.

Tsivgoulis Georgios G Safouris Apostolos A Katsanos Aristeidis H AH Arthur Adam S AS Alexandrov Andrei V AV

Brain and behavior 20160107 2

<h4>Background and purpose</h4>After numerous attempts to prove efficacy for endovascular treatment of ischemic stroke, a series of recent randomized controlled clinical trials (RCTs) established fast mechanical thrombectomy (MT) as a safe and effective novel treatment for emergent large vessel occlusion (ELVO) in the anterior cerebral circulation.<h4>Methods</h4>We reviewed five recent RCTs that evaluated the safety and efficacy of MT in ELVO patients and captured available information on recan ...[more]

PMID: 27110444

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Project description:IntroductionMechanical thrombectomy (MT) has been reported to be effective within 24 h after last known well (LKW) by the DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo) trial and within 16 h after LKW by the DEFUSE-3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3) trial. However, there have been few reports of MT more than 16 h after LKW, and the efficacy and safety of MT more than 24 h after LKW have not yet been demonstrated. We evaluated the efficacy and safety of MT more than 16 h after LKW.MethodsUsing data from the Nippon Medical School Hospital MT registry from April 2011 to August 2022, consecutive patients with anterior circulation large vessel occlusion (LVO) and prehospital modified Rankin scale (mRS) scores of 0-3 were enrolled. Patients were classified into the following three groups: early group (LKW <6 h); middle group (LKW 6-16 h); and late group (LKW >16 h). The clinical characteristics and outcomes were compared among these three groups.ResultsAmong 778 patients in the MT registry, 624 were enrolled. The early group included 432 patients, the middle group included 123 patients, and the late group included 69 patients. The patients had a median age of 77 years (interquartile range, 68-83) and 359 were male (57.5%). The median prehospital mRS score was 1 (interquartile range, 1-1), median National Institutes of Health Stroke Scale score on admission was 17 (interquartile range, 10-23), and median Alberta Stroke Program Early CT score was 10 (interquartile range, 8-10). Regarding safety and efficacy, the proportions of cases with successful reperfusion (modified Thrombolysis in Cerebral Infarction score of 2b-3; 85.4% vs 92.7% vs 88.7%; P=.47), symptomatic intracranial haemorrhage (6.4% vs 5.7% vs 7.2%; P=.99), mRS score ≤3 at 90 days (52.0% vs 60.2% vs 44.9%; P=.11), and mRS score of 6 at 90 days (11.3% vs 10.6 vs 8.7%; P=.37) were not significantly different between the three groups.ConclusionPatients who received MT more than 16 h after LKW experienced the same safety and efficacy as those who received MT at 0-16 h after LKW. MT more than 16 h after LKW may be safe and effective for stroke patients with LVO.

Project description:PurposeElderly people represent a growing stroke population with different pathophysiological states than younger. Whether intravenous thrombolysis (IVT) before mechanical thrombectomy (MT) is beneficial for elderly patients remains unclear. This study compared the efficacy and safety between elderly patients treated with MT alone and those treated with both IVT and MT.Patients and methodsPatients aged ≥65 years who were eligible for IVT within 4.5 h from symptom onset were selected from the ANGEL-ACT (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) registry, a prospective registry program for patients with endovascular treatment from 111 Chinese stroke centers. The primary efficacy outcome was the 90-day modified Rankin Scale score. We compared efficacy and safety outcomes using ordinal or binary logistic regression or a generalized linear model.ResultsIn total, 482 elderly patients were included: 187 (38.8%) received IVT and MT (bridging MT) and 295 (61.2%) received MT alone (direct MT). There was no significant difference in the 90-day modified Rankin Scale score between the two groups (median: 4 vs 4 points, respectively; adjusted β=-0.048, P=0.822). The direct MT group had a shorter onset-to-puncture time (225 vs 255 min, respectively; adjusted β=-55.074, P=0.002) and a lower rate of parenchymal hemorrhage type 2 within 24 h (2.80% vs 6.63%, respectively; adjusted odds ratio [OR]=0.287, 95% confidence interval [CI]=0.096-0.856, P=0.025). In addition, the direct MT group showed a trend toward a lower incidence of sICH (5.67% vs 10.06%, adjusted OR=0.453, P=0.061), procedure-related complications (7.12% vs 12.30%, adjusted OR=0.499, P=0.052) and distal or new territorial embolization (4.07% vs 6.95%, adjusted OR=0.450, P=0.093).ConclusionDirect MT had similar efficacy to bridging MT in terms of the 90-day functional outcome in elderly patients, whereas bridging MT had a longer onset-to-puncture time and increased risk of hemorrhagic transformation and procedure-related complications.

Project description:BackgroundRecent trials including DIRECT-MT, DEVT, and SKIP have found that direct mechanical thrombectomy (MT) is equally effective as the combination of MT and intravenous thrombolysis. However, the results of the other trials, namely MR-CLEAN NO-IV and the SWIFT-DIRECT trial have failed to confirm the non-inferiority of direct MT vs. the combination therapy.AimWe aimed to identify prognostic factors of direct MT for anterior circulation large vessel occlusion within 4.5 h.Materials and methodsData from January 2018 to January 2022 were retrospectively collected and analyzed. Adult patients with confirmed anterior circulation large vessel occlusion within 4.5 h of onset with baseline NIHSS of ≥6 and baseline ASPECTS of ≥6 treated using direct MT within 6 h were recruited.ResultsA total of 140 patients were enrolled in the study with a median age of 65.5 years [interquartile range (IQR), 59-76.5], median baseline NIHSS of 13.5 (IQR, 11-16), and median baseline ASPECTS of 8 (IQR, 7-8). Direct MT was feasible in all patients (100%). Successful reperfusion (mTICI 2b-3) was achieved in 124/140 patients (88.6%) with a low rate of complications (8/140, 5.7%). Any type of intracranial hemorrhage (ICH) and symptomatic ICH occurred in 44/140 (31.4%) and 5/140 (3.6%), respectively. Overall, a good outcome (mRS 0-2) was achieved in 93/140 (66.4%), and the mortality rate was 9.3% (13/140 patients). Using multivariate analysis, lower age [odds ratio (OR), 0.96; 95% CI, 0.92-1.00; P = 0.05], low baseline NIHSS (OR, 0.82; 95% CI, 0.74-0.92; P = 0.00), and absence of ICH (OR, 0.29; 95% CI, 0.10-0.81; P = 0.02) were independently associated with favorable outcome. Independent predictors of mortality were baseline NIHSS (OR, 1.21; 95% CI, 1.01-1.46; P = 0.04), successful reperfusion (OR, 0.02; 95% CI, 0.00-0.58; P = 0.02), and ICH (OR, 0.12; 95% CI, 0.02-0.75; P = 0.02). Further analysis showed that the median mRS at 90 days was significantly better in the MCA occlusion group compared to the ICA plus M1 occlusion group [1 (IQR 0-3) vs. 2 (IQR 1-4); P = 0.05].ConclusionsOur findings suggest that direct thrombectomy may be an adequate clinical option for younger patients (≤70) experiencing proximal middle artery occlusion within 4.5 h and who have low baseline NIHSS (≤14).

Project description:Background: Patients with large vessel occlusion stroke (LVOS) eligible for mechanical thrombectomy (MT) are at risk for stroke- and non-stroke-related complications resulting in the need for tracheostomy (TS). Risk factors for TS have not yet been systematically investigated in this subgroup of stroke patients. Methods: Prospectively derived data from patients with LVOS and MT being treated in a large, academic neurological ICU (neuro-ICU) between 2014 and 2019 were analyzed in this single-center study. Predictive value of peri- and post-interventional factors, stroke imaging, and pre-stroke medical history were investigated for their potential to predict tracheostomy during ICU stay using logistic regression models. Results: From 635 LVOS-patients treated with MT, 40 (6.3%) underwent tracheostomy during their neuro-ICU stay. Patients receiving tracheostomy were younger [71 (62-75) vs. 77 (66-83), p < 0.001], had a higher National Institute of Health Stroke Scale (NIHSS) at baseline [18 (15-20) vs. 15 (10-19), p = 0.009] as well as higher rates of hospital acquired pneumonia (HAP) [39 (97.5%) vs. 224 (37.6%), p < 0.001], failed extubation [15 (37.5%) vs. 19 (3.2%), p < 0.001], sepsis [11 (27.5%) vs. 16 (2.7%), p < 0.001], symptomatic intracerebral hemorrhage [5 (12.5%) vs. 22 (3.9%), p = 0.026] and decompressive hemicraniectomy (DH) [19 (51.4%) vs. 21 (3.8%), p < 0.001]. In multivariate logistic regression analysis, HAP (OR 21.26 (CI 2.76-163.56), p = 0.003], Sepsis [OR 5.39 (1.71-16.91), p = 0.004], failed extubation [OR 8.41 (3.09-22.93), p < 0.001] and DH [OR 9.94 (3.92-25.21), p < 0.001] remained as strongest predictors for TS. Patients with longer periods from admission to TS had longer ICU length of stay (r = 0.384, p = 0.03). There was no association between the time from admission to TS and clinical outcome (NIHSS at discharge: r = 0.125, p = 0.461; mRS at 90 days: r = -0.179, p = 0.403). Conclusions: Patients with LVOS undergoing MT are at high risk to require TS if extubation after the intervention fails, DH is needed, and severe infectious complications occur in the acute phase after ischemic stroke. These factors are likely to be useful for the indication and timing of TS to reduce overall sedation and shorten ICU length of stay.

Project description:Background and Purpose: It is believed that stroke occurring due to posterior circulation large vessel occlusion (PCLVO) and that occurring due to anterior circulation large vessel occlusion (ACLVO) differ in terms of their pathophysiology and the outcome of their acute management in relation to endovascular mechanical thrombectomy (MT). Limited sample size and few randomized controlled trials (RCTs) with respect to PCLVO make the safety and efficacy of MT, which has been confirmed in ACLVO, difficult to assess in the posterior circulation. We therefore conducted a meta-analysis to study to which extent MT in PCLVO differs from ACLVO. Materials and Methods: We searched the databases PubMed, Cochrane, and EMBASE for studies published between 2010 and January 2021, with information on risk factors, safety, and efficacy outcomes of MT in PCLVO vs. ACLVO and conducted a systematic review and meta-analysis; we compared baseline characteristics, reperfusion treatment profiles [including rates of intravenous thrombolysis (IVT) and onset-to-IVT and onset-to-groin puncture times], recanalization success [Thrombolysis In Cerebral Infarction scale (TICI) 2b/3], symptomatic intracranial hemorrhage (sICH), and favorable functional outcome [modified Rankin Score (mRS) 0-2] and mortality at 90 days. Results: Sixteen studies with MT PCLVO (1,172 patients) and ACLVO (7,726 patients) were obtained from the search. The pooled estimates showed higher baseline National Institutes of Health Stroke Scale (NIHSS) score (SMD 0.32, 95% CI 0.15-0.48) in the PCLVO group. PCLVO patients received less often IVT (OR 0.65, 95% CI 0.53-0.79). Onset-to-IVT time (SMD 0.86, 95% CI 0.45-1.26) and onset-to-groin puncture time (SMD 0.59, 95% CI 0.33-0.85) were longer in the PCLVO group. The likelihood of obtaining successful recanalization and favorable functional outcome at 90 days was comparable between the two groups. PCLVO was, however, associated with less sICH (OR 0.56, 95% CI 0.37-0.85) but higher mortality (OR 1.92, 95% CI 1.46-2.53). Conclusions: This meta-analysis indicates that MT in PCLVO may be comparably efficient in obtaining successful recanalization and 90 day favorable functional outcome just as in ACLVO. Less sICH in MT-treated PCLVO patients might be the result of the lower IVT rate in this group. Higher baseline NIHSS and longer onset-to-IVT and onset-to-groin puncture times may have contributed to a higher 90 day mortality in PCLVO patients.

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Mechanical thrombectomy for emergent large vessel occlusion: a critical appraisal of recent randomized controlled clinical trials.

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Mechanical thrombectomy for emergent large vessel occlusion: a critical appraisal of recent randomized controlled clinical trials.

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