scholarly journals Combined intravenous and endovascular treatment versus primary mechanical thrombectomy. The Italian Registry of Endovascular Treatment in Acute Stroke

2019 ◽  
Vol 14 (9) ◽  
pp. 898-907 ◽  
Author(s):  
Ilaria Casetta ◽  
Giovanni Pracucci ◽  
Andrea Saletti ◽  
Valentina Saia ◽  
Marina Padroni ◽  
...  

Background Whether mechanical thrombectomy alone may achieve better or at least equal clinical outcome than mechanical thrombectomy combined with intravenous thrombolysis is a matter of debate. Methods From the Italian Registry of Endovascular Stroke Treatment, we extracted all cases treated with intravenous thrombolysis followed by mechanical thrombectomy or with primary mechanical thrombectomy for anterior circulation stroke due to proximal vessel occlusion. We included only patients who would have qualified for intravenous thrombolysis. We compared outcomes of the two groups by using multivariate regression analysis and propensity score method. Results We included 1148 patients, treated with combined intravenous thrombolysis and mechanical thrombectomy therapy (n = 635; 55.3%), or with mechanical thrombectomy alone (n = 513; 44.7%). Demographic and baseline clinical characteristics did not differ between the two groups, except for a shorter onset to groin puncture time (p < 0.05) in the mechanical thrombectomy group. A shift in the 90-day modified Rankin Scale distributions toward a better outcome was found in favor of the combined treatment (adjusted common odds ratio  = 1.3; 95% confidence interval: 1.04–1.66). Multivariate analyses on binary outcome show that subjects who underwent combined treatment had higher probability to survive with modified Rankin Scale 0–3 (odds ratio = 1.42; 95% confidence interval: 1.04–1.95) and lower case fatality rate (odds ratio = 0.6; 95% confidence interval: 0.44–0.9). Hemorrhagic transformation did not differ between the two groups. Conclusion These data seem to indicate that combined intravenous thrombolysis and mechanical thrombectomy could be associated with lower probability of death or severe dependency after three months from stroke due to large vessel occlusion, supporting the current guidelines of treating eligible patients with intravenous thrombolysis before mechanical thrombectomy.

2021 ◽  
pp. 197140092110091
Author(s):  
Hanna Styczen ◽  
Matthias Gawlitza ◽  
Nuran Abdullayev ◽  
Alex Brehm ◽  
Carmen Serna-Candel ◽  
...  

Background Data on outcome of endovascular treatment in patients with acute ischaemic stroke due to large vessel occlusion suffering from intravenous thrombolysis-associated intracranial haemorrhage prior to mechanical thrombectomy remain scarce. Addressing this subject, we report our multicentre experience. Methods A retrospective analysis of consecutive acute ischaemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion despite the pre-interventional occurrence of intravenous thrombolysis-associated intracranial haemorrhage was performed at five tertiary care centres between January 2010–September 2020. Baseline demographics, aetiology of stroke and intracranial haemorrhage, angiographic outcome assessed by the Thrombolysis in Cerebral Infarction score and clinical outcome evaluated by the modified Rankin Scale at 90 days were recorded. Results In total, six patients were included in the study. Five individuals demonstrated cerebral intraparenchymal haemorrhage on pre-interventional imaging; in one patient additional subdural haematoma was observed and one patient suffered from isolated subarachnoid haemorrhage. All patients except one were treated by the ‘drip-and-ship’ paradigm. Successful reperfusion was achieved in 4/6 (67%) individuals. In 5/6 (83%) patients, the pre-interventional intracranial haemorrhage had aggravated in post-interventional computed tomography with space-occupying effect. Overall, five patients had died during the hospital stay. The clinical outcome of the survivor was modified Rankin Scale=4 at 90 days follow-up. Conclusion Mechanical thrombectomy in patients with intravenous thrombolysis-associated intracranial haemorrhage is technically feasible. The clinical outcome of this subgroup of stroke patients, however, appears to be devastating with high mortality and only carefully selected patients might benefit from endovascular treatment.


2019 ◽  
Vol 15 (2) ◽  
pp. 167-174 ◽  
Author(s):  
Charlotte Zerna ◽  
Tyler Burley ◽  
Theresa L Green ◽  
Sean P Dukelow ◽  
Andrew M Demchuk ◽  
...  

Background and Purpose The modified Rankin Scale (mRS) is the most widely used primary outcome measure in acute stroke trials. However, substantial interobserver variability impairs outcome assessment as well as reduces power of clinical trials. Guided by the International Classification of Functioning, Disability and Health, we developed a comprehensive, hierarchical assessment tool (miFUNCTION) to address the shortcomings of the modified Rankin Scale and deliver a more thorough understanding of disability following stroke. Methods The initial construct validity of miFUNCTION was established in a pilot study of patients at an outpatient stroke prevention clinic that had been diagnosed with stroke within 60 days. To further assess criterion validity, miFUNCTION was compared against the modified Rankin Scale and other outcome measures within the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial. Logistic regression analysis with miFUNCTION as an outcome was used to demonstrate the beneficial effect of endovascular treatment. Results The pilot study showed moderate inter-observer agreement (k = 0.585, p < 0.005) but near perfect correlation between miFUNCTION and modified Rankin Scale (ρ = 0.821, p < 0.05). The correlation of miFUNCTION and modified Rankin Scale was near perfect again in the ESCAPE trial (ρ = 0.944). Effect size of the multivariable models using modified Rankin Scale (adjusted odds ratio: 3.45, 95% confidence interval: 2.05–5.78) and miFUNCTION (adjusted odds ratio: 3.32, 95% confidence interval: 1.99–5.55) as an outcome measure for the ESCAPE trial patients was similar. Conclusions miFUNCTION is strongly associated with the degree of disability following stroke both in an outpatient setting and a clinical trial. Further work remains to assess sensitivity to change and to improve the inter-observer reliability of the scale.


Stroke ◽  
2020 ◽  
Vol 51 (11) ◽  
pp. 3205-3214
Author(s):  
Sophie A. van den Berg ◽  
Simone M. Uniken Venema ◽  
Maxim J.H.L. Mulder ◽  
Kilian M. Treurniet ◽  
Noor Samuels ◽  
...  

Background and Purpose: Optimal blood pressure (BP) targets before endovascular treatment (EVT) for acute ischemic stroke are unknown. We aimed to assess the relation between admission BP and clinical outcomes and successful reperfusion after EVT. Methods: We used data from the MR CLEAN (Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry, an observational, prospective, nationwide cohort study of patients with ischemic stroke treated with EVT in routine clinical practice in the Netherlands. Baseline systolic BP (SBP) and diastolic BP (DBP) were recorded on admission. The primary outcome was the score on the modified Rankin Scale at 90 days. Secondary outcomes included successful reperfusion (extended Thrombolysis in Cerebral Infarction score 2B-3), symptomatic intracranial hemorrhage, and 90-day mortality. Multivariable logistic and linear regression were used to assess the associations of SBP and DBP with outcomes. The relations between BPs and outcomes were tested for nonlinearity. Parameter estimates were calculated per 10 mm Hg increase or decrease in BP. Results: We included 3180 patients treated with EVT between March 2014 and November 2017. The relations between admission SBP and DBP with 90-day modified Rankin Scale scores and mortality were J-shaped, with inflection points around 150 and 81 mm Hg, respectively. An increase in SBP above 150 mm Hg was associated with poor functional outcome (adjusted common odds ratio, 1.09 [95% CI, 1.04–1.15]) and mortality at 90 days (adjusted odds ratio, 1.09 [95% CI, 1.03–1.16]). Following linear relationships, higher SBP was associated with a lower probability of successful reperfusion (adjusted odds ratio, 0.97 [95% CI, 0.94–0.99]) and with the occurrence of symptomatic intracranial hemorrhage (adjusted odds ratio, 1.06 [95% CI, 0.99–1.13]). Results for DBP were largely similar. Conclusions: In patients with acute ischemic stroke treated with EVT, higher admission BP is associated with lower probability of successful reperfusion and with poor clinical outcomes. Further research is needed to investigate whether these patients benefit from BP reduction before EVT.


Stroke ◽  
2021 ◽  
Author(s):  
Marian Douarinou ◽  
Benjamin Gory ◽  
Arturo Consoli ◽  
Bertrand Lapergue ◽  
Maeva Kyheng ◽  
...  

Background and Purpose: Approximately half of the patients with acute ischemic stroke due to anterior circulation large vessel occlusion do not achieve functional independence despite successful reperfusion. We aimed to determine influence of reperfusion strategy (bridging therapy, intravenous thrombolysis alone, or mechanical thrombectomy alone) on clinical outcomes in this population. Methods: From ongoing, prospective, multicenter, observational Endovascular Treatment in Ischemic Stroke registry in France, all patients with anterior circulation large vessel occlusion who achieved successful reperfusion (modified Thrombolysis in Cerebral Infarction 2b-3) following reperfusion therapy were included. Primary end point was favorable outcome, defined as 90-day modified Rankin Scale score ≤2. Patient groups were compared using those treated with bridging therapy as reference. Differences in baseline characteristics were reduced after propensity score-matching, with a maximum absolute standardized difference of 14% for occlusion site. Results: Among 1872 patients included, 970 (51.8%) received bridging therapy, 128 (6.8%) received intravenous thrombolysis alone, and the remaining 774 (41.4%) received MT alone. The rate of favorable outcome was comparable between groups. Excellent outcome (90-day modified Rankin Scale score 0–1) was achieved more frequently in the bridging therapy group compared with the MT alone (odds ratio after propensity score-matching, 0.70 [95% CI, 0.50–0.96]). Regarding safety outcomes, hemorrhagic complications were similar between the groups, but 90-day mortality was significantly higher in the MT alone group compared with the bridging therapy group (odds ratio, 1.60 [95% CI, 1.09–2.37]). Conclusions: This real-world observational study of patients with anterior circulation large vessel occlusion demonstrated a similar rate of favorable outcome following successful reperfusion with different therapeutic strategies. However, our results suggest that bridging therapy compared with MT alone is significantly associated with excellent clinical outcome and lower mortality. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03776877.


Stroke ◽  
2019 ◽  
Vol 50 (11) ◽  
pp. 3164-3169 ◽  
Author(s):  
Eve Drouard-de Rousiers ◽  
Ludovic Lucas ◽  
Sébastien Richard ◽  
Arturo Consoli ◽  
Mikaël Mazighi ◽  
...  

Background and Purpose— Nonagenarians represent a growing stroke population characterized by a higher frailty. Although endovascular therapy (ET) is a cornerstone of the management of acute ischemic stroke related to large vessel occlusion, the benefit of reperfusion among nonagenarians is poorly documented. We aimed to assess the impact of ET-related reperfusion on the functional outcome of reperfusion in this elderly population. Methods— A retrospective analysis of clinical and imaging data from all patients aged over 90 included in the ETIS (Endovascular Treatment in Ischemic Stroke) registry between October 2013 and April 2018 was performed. Association between post-ET reperfusion and favorable (modified Rankin Scale [0–2] or equal to prestroke value) and good (modified Rankin Scale [0–3] or equal to prestroke value) outcome were evaluated. Demographic and procedural predictors of functional outcome, including the first-pass effect, were evaluated. Results were adjusted for center, admission National Institutes of Health Stroke Scale, and use of intravenous thrombolysis. Results— Among the 124 nonagenarians treated with ET, those with successful reperfusion had the lowest 90-day modified Rankin Scale (odds ratio, 3.26; 95% CI, 1.04–10.25). Only patients with successful reperfusion after the first pass (n=53, 56.7%) had a reduced 90-day mortality (odds ratio, 0.15; 95% CI, 0.05–0.45) and an increased rate of good outcome (odds ratio, 4.55; 95% CI, 1.38–15.03). No increase in the rate of intracranial hemorrhage was observed among patients successfully reperfused. Conclusions— Successful reperfusion improves the functional outcome of nonagenarians who should not be excluded from ET. The first-pass effect should be considered in the procedural management of this frail population.


Stroke ◽  
2021 ◽  
Author(s):  
Xu Tong ◽  
Yilong Wang ◽  
Jens Fiehler ◽  
Clayton T. Bauer ◽  
Baixue Jia ◽  
...  

Background and Purpose: A recent randomized controlled trial DIRECT-MT (Direct Intra-Arterial Thrombectomy to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals) compared the safety and efficacy of mechanical thrombectomy (MT) versus combined intravenous thrombolysis (IVT) and MT for acute large vessel occlusion. The current study utilized a prospective, nationwide registry to validate the results of the DIRECT-MT trial in a real-world practice setting. Methods: Subjects were selected from a prospective cohort of acute large vessel occlusion patients undergoing endovascular treatment at 111 hospitals from 26 provinces in China (ANGEL-ACT registry [Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke]) between November 2017 and March 2019. All patients eligible for IVT and receiving MT were reviewed and then grouped according to whether prior IVT or not (MT and combined IVT+MT). After a 1:1 propensity score matching, the outcome measures including the 90-day modified Rankin Scale, successful recanalization, door-to-puncture time, symptomatic intracranial hemorrhage, and intraprocedural embolization were compared. Results: A total of 1026 patients, 600 in the MT group and 426 in the combined group, were included. Among 788 patients identified after matching, there were no significant differences in the 90-day modified Rankin Scale (median, 3 versus 3 points; P =0.82) and successful recanalization (86.6% versus 89.3%; P =0.23) between the two groups; however, patients of the MT group had a shorter door-to-puncture time (median, 112 versus 136 minutes; β=−45.02 [95% CI, −68.31 to −21.74]), lower rates of symptomatic intracranial hemorrhage (5.5% versus 10.1%; odds ratio, 0.52 [95% CI, 0.30–0.91]), and embolization (4.6% versus 8.1%; odds ratio, 0.54 [95% CI, 0.30–0.98]) than those of the combined group. Conclusions: This matched-control study largely confirmed the findings of the DIRECT-MT trial in a real-world practice setting, suggesting that MT may carry similar effectiveness to combined IVT+MT for acute large vessel occlusion patients, despite MT alone seems to be associated with a shorter in-hospital delay until procedure, lower risks of symptomatic intracranial hemorrhage, and embolization. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03370939.


2021 ◽  
Vol 51 (1) ◽  
pp. E4
Author(s):  
Sandeep Kandregula ◽  
Amey R. Savardekar ◽  
Pankaj Sharma ◽  
Jerry McLarty ◽  
Jennifer Kosty ◽  
...  

OBJECTIVE A paradigm shift in the management of acute ischemic stroke (AIS) due to large-vessel occlusion (LVO) occurred after 2015 when 7 randomized controlled trials demonstrated better outcomes using second-generation thrombectomy devices combined with best medical management than did stand-alone intravenous thrombolysis (IVT) with tissue plasminogen activator (tPA). All recently published landmark trials were designed to study the outcome of mechanical thrombectomy (MT); therefore, the majority of the patients enrolled in these trials received intravenous tPA. Currently, initiating IVT before MT is a matter of debate. Recent trials (DIRECT-MT, DEVT) exploring this clinical question showed noninferiority of MT alone compared with the combined treatment. With this uncertainty, the authors aimed to explore real-world data through the latest National Inpatient Sample (NIS) to compare the safety and outcomes of MT alone with bridging IVT and MT in AIS due to LVO in the middle cerebral artery (MCA). METHODS NIS data from 2017 to 2018 were analyzed to compare the outcomes and safety profiles of patients who underwent MT+IVT with those who underwent MT alone. RESULTS A total of 2895 patients were included in the final analysis (MT, n = 1669; MT+IVT, n = 1226). The mean National Institutes of Health Stroke Scale score was 16.2 (SD 6.1) in the MT group and 16.6 (SD 5.97) in the MT+IVT group (p = 0.04). With respect to comorbidities, the two groups did not differ in rates of hypertension (p = 0.730), atrial fibrillation/flutter (p = 0.828), and smoking status (p = 0.914). The rate of diabetes mellitus was significantly higher in the MT group (28%) than in the MT+IVT group (22.1%) (p < 0.001). The frequency of intracerebral hemorrhage (ICH) in the MT group was 17.7% (n = 296) and 21.5% (n = 263) in the MT+IVT group (p = 0.012). Intraventricular hemorrhage (p = 0.875), subarachnoid hemorrhage (p = 0.99), and vasospasm (p = 0.976) did not differ significantly between the groups. The primary outcome considered was disability status between the groups; 23.8% of patients in the MT+IVT group had minimal disability versus 18.2% in the MT group (p = 0.001). The risk of progressing to severe disability from minimal disability decreased with the addition of IVT to MT (OR 0.762, 95% CI 0.637–0.912). The adjusted odds ratio for ICH in the MT+IVT group was 1.28 (95% CI 1.043–1.571, p = 0.018) and 2.676 (95% CI 1.259–5.686, p = 0.01) for access-site hemorrhages. CONCLUSIONS In the analysis of the NIS database, the MT+IVT group had significantly higher rates of minimal disability at the time of hospital discharge versus the MT-alone group, despite a higher rate of ICH. The question of whether to treat patients with MT+IVT rather than MT alone is currently being addressed in ongoing prospective clinical trials (SWIFT-DIRECT [NCT03494920], MR CLEAN–NO IV [ISRCTN80619088], and DIRECT-SAFE [NCT03494920]). The results of these studies will contribute to greater understanding and progressive improvement in outcomes for AIS patients.


2019 ◽  
Vol 11 (12) ◽  
pp. 1205-1209 ◽  
Author(s):  
Yoshinori Kadono ◽  
Hajime Nakamura ◽  
Shunsuke Saito ◽  
Takeo Nishida ◽  
Masatoshi Takagaki ◽  
...  

BackgroundEmbolic stroke with large vessel occlusion (LVO) is a major adverse event during ventricular assist device (VAD) support. In this study we aimed to clarify the efficacy of, and problems associated with, endovascular treatment (EVT) of LVO in patients with VAD support.MethodsWe retrospectively reviewed EVT for LVO in patients with VAD support between 2006 and 2017 at our institute and evaluated baseline characteristics, treatment variables, outcomes, and complications.ResultsThe study cohort comprised 12 consecutive patients (age 35.4±20.4 years), with 15 LVO events involving 20 arterial occlusions, who had undergone EVT. The median Alberta Stroke Program Early CT score was 10 and good collaterals were observed in 10 of 17 occluded middle cerebral artery areas. No study patients had received intravenous thrombolysis therapy. EVT was performed on 18 of the 20 occluded arteries and mechanical thrombectomy on 13 vessels. The successful reperfusion (modified Thrombolysis in Cerebral Infarction grade ≥2 b) rate was 67% in all EVTs and 85% with mechanical thrombectomy. Histological analysis showed fibrin-rich thrombi in four of five samples. Seven of 12 patients (58%) maintained their neurological function (modified Rankin Scale score ≤2 or equal to pre-stroke score) at 90 days. Periprocedural complications comprised two symptomatic intracranial hemorrhages and the 90-day mortality rate was 13%. Seven of 10 cardiac transplant candidates (70%) returned to the waiting list and three of them received transplants.ConclusionsEndovascular therapy for acute LVO stroke is feasible even in patients with VAD support.


Stroke ◽  
2021 ◽  
Author(s):  
Mahmoud H. Mohammaden ◽  
Diogo C. Haussen ◽  
Leonardo Pisani ◽  
Alhamza R. Al-Bayati ◽  
Nicolas Bianchi ◽  
...  

Background and Purpose: Despite the lower rates of good outcomes and higher mortality in elderly patients, age does not modify the treatment effect of mechanical thrombectomy for large vessel occlusion strokes. We aimed to study whether racial background influences the outcome after mechanical thrombectomy in the elderly population. Methods: We reviewed a prospectively maintained database of patients with acute ischemic stroke treated with mechanical thrombectomy from October 2010 through June 2020 to identify all consecutive patients with age ≥80 years and anterior circulation large vessel occlusion strokes. The patients were categorized according to their race as Black and White. Univariable and multivariable analyses were performed to define the predictors of 90-day modified Rankin Scale and mortality in the overall population and in each race separately. Results: Among 2241 mechanical thrombectomy, a total of 344 patients (median [interquartile range]; age 85 [82–88] years, baseline National Institutes of Health Stroke Scale score of 19 [15–23], Alberta Stroke Program Early CT Score 9 [7–9], 69.5% females) were eligible for the analysis. White patients (n=251; 73%) had significantly lower median body mass index (25.37 versus 26.89, P =0.04) and less frequent hypertension (78.9% versus 90.3%, P =0.01) but more atrial fibrillation (64.5% versus 44.1%, P =0.001) compared with African Americans (n=93; 27%). Other clinical, imaging, and procedural characteristics were comparable between groups. The rates of symptomatic intracerebral hemorrhage, 90-day modified Rankin Scale score of 0 to 2, and mortality were comparable among both groups. On multivariable analysis, race was neither a predictor of 90-day modified Rankin Scale score of 0 to 2 (White race: odds ratio, 0.899 [95% CI, 0.409–1.974], P =0.79) nor 90-day mortality (White race: odds ratio, 1.368; [95% CI, 0.715–2.618], P =0.34). Conclusions: In elderly patients undergoing mechanical thrombectomy for acute ischemic stroke, there was no racial difference in terms of outcome.


Author(s):  
Juha-Pekka Pienimäki ◽  
Jyrki Ollikainen ◽  
Niko Sillanpää ◽  
Sara Protto

Abstract Purpose Mechanical thrombectomy (MT) is the first-line treatment in acute stroke patients presenting with large vessel occlusion (LVO). The efficacy of intravenous thrombolysis (IVT) prior to MT is being contested. The objective of this study was to evaluate the efficacy of MT without IVT in patients with no contraindications to IVT presenting directly to a tertiary stroke center with acute anterior circulation LVO. Materials and Methods We collected the data of 106 acute stroke patients who underwent MT in a single high-volume stroke center. Patients with anterior circulation LVO eligible for IVT and directly admitted to our institution who subsequently underwent MT were included. We recorded baseline clinical, laboratory, procedural, and imaging variables and technical, imaging, and clinical outcomes. The effect of intravenous thrombolysis on 3-month clinical outcome (mRS) was analyzed with univariate tests and binary and ordinal logistic regression analysis. Results Fifty-eight out of the 106 patients received IVT + MT. These patients had 2.6-fold higher odds of poorer clinical outcome in mRS shift analysis (p = 0.01) compared to MT-only patients who had excellent 3-month clinical outcome (mRS 0–1) three times more often (p = 0.009). There were no significant differences between the groups in process times, mTICI, or number of hemorrhagic complications. A trend of less distal embolization and higher number of device passes was observed among the MT-only patients. Conclusions MT without prior IVT was associated with an improved overall three-month clinical outcome in acute anterior circulation LVO patients.


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