IV Thrombolysis Research Articles

Ischemic stroke treated with mechanical thrombectomy: 3 year data from stroke registry in Al Ain Hospital, UAE

Mechanical thrombectomy with or without iv thrombolysis is indicated for treatment of acute ischemic stroke due to large vessel occlusion. The Stroke Unit in Al Ain Hospital in Al Ain, UAE is CCPC-accredited in ischemic strokes. We present the results of mechanical thrombectomy for acute ischemic stroke from our unit. We analysed data from our comprehensive Stroke Registry. Baseline demographics including age, gender, baseline NIHSS, stroke subtype, imaging results, type of intervention, type of endovascular device used, symptom onset to groin puncture time, complications, mortality and mRS at discharge were analysed. A total of 17 patients were treated during the 36 month period starting January 2016 with mechanical thrombectomy. Age range was from 36 year to 82 years. 13 males and 4 females. Baseline NIHSS varied from 11 to 30. 3 patients had additional stenting done. 90% showed occlusion in anterior circulation. Intravenous rtpA was given in 44% of patients. Average Symptom to Groin puncture Time (STG) was 224 minutes. 88% of patients showed complete recanalisation (TICI 2b/3) immediately after the procedure. No immediate complications were seen in any of the patients. Mortality rate was 24%. At discharge, 24% achieved mRS score of ≤ 2; 29% achieved mRS score of 3-4. We conclude that mechanical thrombectomy was successful radiologically and good or moderate clinical outcome was achieved in 53% of patients.

Arrival times of patient with ischemic stroke at emergency room: Comparison of two time periods a study in South India

Intravenous thrombolysis and endovascular thrombectomy are the proven treatments for ischemic stroke. These treatments are time-based. This study aims at finding changes in the arrival times of patients with ischemic stroke between two time periods This is a retrospective analysis of prospectively collected stroke registry data. The study compared arrival times of patients with ischemic stroke at Emergency Room between two time periods: 2008-2010 (T-I) vs. 2016-2018 (T-II). Patients with first ever new stroke were included. TOAST criteria were applied to determine the stroke sub type. There were 549 and 451 patients in T-I and T-II periods respectively. Clinical differences between T-II vs. T-I were elderly age 60.76+14.35 vs. 58.30+13.64 p<005); and less severe stroke (NIHSS: 6.53+5.82 vs. 10.7+3.0 p<0001). During T-II period more patients arrived in the window period for iv thrombolysis (100 vs. 56 p<0.0001) and more patients received iv thrombolysis (91 vs. 40 p<0.0001). Number of patients with proximal occlusive disease who arrived in the window period (<6 h) for possible endovascular treatment were (T-II vs. TI) 20 vs. 15 (p<0.14) and 4 patients received the therapy in T-II. Patients who could be possible candidates for thrombectomy in 7-24 h were (T-II vs. T-I) 29 vs. 29 (p<0.43). This study suggests that there is increased awareness of stroke and stroke treatment in this part of India. More patients utilized thrombolysis treatment.

Exploring the relationship between ischemic core volume and clinical outcomes after thrombectomy or thrombolysis.

To assess whether complete reperfusion after IV thrombolysis (IVT-R) would result in similar clinical outcomes compared to complete reperfusion after endovascular thrombectomy (EVT-R) in patients with a large vessel occlusion (LVO). EVT-R patients were matched by age, clinical severity, occlusion location, and baseline perfusion lesion volume to IVT-R patients from the International Stroke Perfusion Imaging Registry (INSPIRE). Only patients with complete reperfusion on follow-up imaging were included. The excellent clinical outcome rates at day 90 on the modified Rankin Scale (mRS) were compared between EVT-R vs IVT-R patients within quintiles of increasing baseline ischemic core and penumbral volumes. From INSPIRE, there were 141 EVT-R patients and 141 matched controls (IVT-R) who met the eligibility criteria. In patients with a baseline core <30 mL, EVT-R resulted in a lower odds of achieving an excellent outcome at day 90 compared to IVT-R (day 90 mRS 0-1 odds ratio 0.01, p < 0.001). The group with a baseline core <30 mL contained mostly patients with distal M1 or M2 occlusions, and good collaterals (p = 0.01). In patients with a baseline ischemic core volume >30 mL (internal carotid artery and mostly proximal M1 occlusions), EVT-R increased the odds of patients achieving an excellent clinical outcome (day 90 mRS 0-1 odds ratio 1.61, p < 0.001) and there was increased symptomatic intracranial hemorrhage in the IVT-R group with core >30 mL (20% vs 3% in EVT-R, p = 0.008). From this observational cohort, LVO patients with larger baseline ischemic cores and proximal LVO, with poorer collaterals, clearly benefited from EVT-R compared to IVT-R alone. However, for distal LVO patients, with smaller ischemic cores and better collaterals, EVT-R was associated with a lower odds of favorable outcome compared to IVT-R alone.

Stable Extracranial ICA Patency after Mechanical Thrombectomy for Ischemic Stroke Patients with Tandem Occlusions: Major determinant of favorable outcome

Mechanical thrombectomy (MT) for acute ischemic stroke (AIS) with tandem occlusion is efficient, but optimal management of the extracranial occlusive component remains controversial. We investigated the association between extracranial internal carotid artery (ICA) patency on day 1 follow-up MR-Angiography and clinical outcome after MT in AIS patients with tandem occlusion. Consecutive AIS patients with tandem occlusion were identified from a hospital-based prospective registry from January 2011 to January 2017. Baseline clinical-imaging characteristics, angiographic outcomes and day 1 follow-up imaging findings (including extracranial ICA patency as assessed by MR-Angiography) were analyzed with regards to their associations with 3-month modified Rankin scale (mRS) scores. Favorable outcome was defined as a mRS score 0–2 at 3 months. Out of 594 AIS patients treated with MT during the study period, 83 met inclusion criteria (69.9% male, aged 62.3 ± 12.3). Mean NIHSS was 17.9 ± 4.8 and median ASPECTS was 7. Successful re-canalization (mTICI 2b/3) was achieved in 61.5%. Extracranial ICA was patent in 37/83 patients (44.6%) at day 1, more frequently in those with prior IV thrombolysis (P = 0.035) or with cervical re-vascularization procedure (balloon angioplasty or stenting, P = 0.034). Favorable 3-month functional outcome was more frequent in patients with patent extracranial ICA at day 1 (64.9% vs 21.7%, P < 0.0001) independently of intracranial recanalization success. No difference was found in terms of sICH (13.5% vs 10.9%, P = 0.75) or 3-month mortality rate (8.1% vs 17.4%, P = 0.33). This study highlights the importance of stable extracranial ICA patency in determining outcome of AIS patients with tandem occlusions. Randomized studies are needed.

Predictors of new remote cerebral microbleeds after IV thrombolysis for ischemic stroke.

To assess the frequency, associated factors, and underlying vasculopathy of new remote cerebral microbleeds (CMB), as well as the risk of concomitant hemorrhagic complications related to new CMBs, after IV thrombolysis (IVT) in acute stroke patients. We conducted an observational study using data from our local thrombolysis registry. We included consecutive stroke patients with MRI (3T)-based IVT and a follow-up MRI the next day between 2008 and 2017 (n = 396). Only CMBs located outside of the ischemic lesions were considered. We also performed a meta-analysis on new CMBs after IVT that included 2 additional studies. In our cohort, new remote CMBs occurred in 16/396 patients (4.0%) after IVT and the distribution was strictly lobar in 13/16 patients (81%). Patients with preexisting CMBs with a strictly lobar distribution were significantly more likely to have new CMBs after IVT (p = 0.014). In the random-effects meta-analysis (n = 741), the pooled cumulative frequency of new CMBs after IVT was 4.4%. A higher preexisting CMB burden (>2) was associated with a higher likelihood of new CMBs (odds ratio [OR] 3.6, 95% confidence interval [CI] 1.3-10.3) and new CMBs were associated with the occurrence of remote parenchymal hemorrhage (OR 28.8, 95% CI 8.6-96.4). New remote CMBs after IVT occurred in 4% of stroke patients, mainly had a strictly lobar distribution, and were associated with IVT-related hemorrhagic complications. Preexisting CMBs with a strictly lobar distribution and a higher CMB burden were associated with new CMBs after IVT, which may indicate an underlying cerebral amyloid angiopathy.

Editors' note: Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion

In their multicenter observational study titled “Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion,” Goyal et al. found that IV thrombolysis (IVT) before mechanical thrombectomy (MT) was associated with higher odds of functional independence at 3 months. Ganesh et al. propose that this may be related to a lower risk of infarction in unrelated vascular territories among patients pretreated with IVT. Further, Ganesh et al. note that an important minority of patients selected for thrombectomy may not achieve successful recanalization; therefore IVT may be the only chance to facilitate reperfusion. LeCouffe et al.—who represent the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN)–NO IV Investigators and are prospectively evaluating the benefit of IVT before MT—address the importance of blood pressure and coagulopathy as confounders. These unmeasured variables might have influenced the propensity matching in this investigation. In response to these comments, Goyal et al. acknowledge the limitations of observational studies where unmeasured, but important, clinical variables may not be captured during data acquisition. Ultimately, the superiority of combination IVT + MT over MT alone may not be confirmed until the results of ongoing prospective clinical trials are published. In their multicenter observational study titled “Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion,” Goyal et al. found that IV thrombolysis (IVT) before mechanical thrombectomy (MT) was associated with higher odds of functional independence at 3 months. Ganesh et al. propose that this may be related to a lower risk of infarction in unrelated vascular territories among patients pretreated with IVT.

Author response: Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion.

We thank Ganesh et al. for reading and commenting on our article on the comparative safety and efficacy of combined IV thrombolysis (IVT) and mechanical thrombectomy (MT) with direct MT in patients with emergent large vessel occlusion (ELVO).1 We agree that IVT pretreatment can protect from infarct in new territory (INT), and may account for improved outcomes observed in the combination therapy (IVT + MT) group. Data on INT were not collected in our cohort. However, INT should be evaluated as one of the outcomes variables in future MT trials. We are also in support of another point made by Ganesh et al. about the recanalization rates with IVT alone. According to a recently published meta-analysis, roughly 1 of 10 patients with ELVO achieve successful recanalization with IVT pretreatment alone, negating the need for additional endovascular reperfusion therapy.2 Although this rate is low, pretreatment with IVT appears to be important. Finally, we followed the suggestion of Ganesh et al. and compared outcomes (safety and efficacy) between direct MT (dMT) and combination therapy in the subgroup of patients with intracranial ICA occlusions. We failed to document any differences in the safety and efficacy outcomes between the 2 groups, but the small number of patients with ICA occlusions (n = 29), corresponding to 9% of the total matched cohort, needs to be taken into account in the interpretation of this subgroup analysis.

Reader response: Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion.

In their article, Goyal et al.1 questioned the added benefit of IV thrombolysis (IVT) prior to mechanical thrombectomy (MT) in patients with ischemic stroke and a large vessel occlusion. As we await the results of ongoing randomized trials (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands [MR CLEAN–NO IV], [ISRCTN80619088][1]; Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke [SWIFT DIRECT], [NCT03192332][2]; Direct Intra-arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals [DIRECT-MT], [NCT03469206][3]), we must rely on observational data with adequate adjustment for potential confounding variables to estimate the value of IVT in MT-eligible patients.2 Goyal et al.1 rightfully stated that no statistical method can completely adjust for allocation bias. However, current American Heart Association guidelines state that a blood pressure above 185/110 mm Hg and impaired hemostasis (direct oral anticoagulant use or international normalized ratio >1.7) are contraindications for IVT.3 These variables have also been associated with worse outcomes4 and, therefore, are true confounders. Much to our surprise, data on baseline blood pressure and hemostasis were not reported in by Goyal et al.,1 and it does not appear that these variables were used in the propensity score matching. We invite the authors to comment on why information on baseline blood pressure and hemostasis was not reported and how this may have affected their results. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN80619088 [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03192332&atom=%2Fneurology%2F91%2F24%2F1115.atom [3]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03469206&atom=%2Fneurology%2F91%2F24%2F1115.atom

Re-evaluation of the stroke prognostication using age and NIH Stroke Scale index (SPAN-100 index) in IVT patients \u2014 the-SPAN 10065 index

BackgroundThe SPAN-100 index adds patient age and baseline NIHSS-score and was introduced to predict clinical outcome after acute ischemic stroke (AIS). Even with high NIHSS-scores younger patients cannot reach a SPAN-100-positive status (index ≥100). We aimed to evaluate the SPAN-100 index among a large, contemporary cohort of i.v.-thrombolysed AIS-patients and exclusively among older patients who can at least theoretically achieve SPAN-100-positivity.MethodsThe SPAN-100 index was applied to AIS-patients receiving i.v.-thrombolysis (IVT) in our institution between 01/2006 and 01/2013. Clinical outcome and symptomatic intracerebral hemorrhage rates were compared between SPAN-100-positive and -negative patients. Furthermore we excluded patients < 65 years, without any theoretical chance to achieve SPAN-100-positivity, and re-evaluated the index (SPAN65–100 index).ResultsSPAN-100-positive IVT-patients (124/1002) had a 9-fold increased risk for unfavorable outcome compared to SPAN-negative patients (OR 9.39; 95% CI 5.87–15.02; p < 0.001). The odds ratio for mortality was 7.48 (95% CI 4.90–11.43; p < 0.001). No association was found between SPAN-100-positivity and sICH-incidence (OR 0.88; 95% CI 0.31–2.53; p = 0.810).SPAN65–100-positivity (124/741) was associated with an 8-fold increased risk for unfavorable outcome (OR 7.6; 95% CI 4.71–12.22; p < 0.001) but not associated with higher sICH-rates (OR 0.86; 95% CI 0.29–2.53; p < 0.001).ConclusionsAlso for patients ≥65 years the SPAN-100 index can be a fast, easy method to predict clinical outcome of IVT-patients in everyday practice. However, it should not be used to determine the risk of sICH after IVT. Based on a SPAN-positive status IVT should not be withheld from AIS-patients merely because of feared sICH-complications.

Effect of stroke thrombolysis predicted by distal vessel occlusion detection

Among ischemic stroke patients with negative CT angiography (CTA), we aimed to determine the predictive value of enhanced distal vessel occlusion detection using CT perfusion postprocessing (waveletCTA) for the treatment effect of IV thrombolysis (IVT). Patients were selected from 1,851 consecutive patients who had undergone CT perfusion. Inclusion criteria were (1) significant cerebral blood flow (CBF) deficit, (2) no occlusion on CTA, and (3) infarction confirmed on follow-up. Favorable morphologic response was defined as smaller values of final infarction volume divided by initial CBF deficit volume (FIV/CBF). Favorable functional outcome was defined as modified Rankin Scale score of ≤2 after 90 days and decrease in NIH Stroke Scale score of ≥3 from admission to 24 hours (∆NIHSS). Among patients with negative CTA (n = 107), 58 (54%) showed a distal occlusion on waveletCTA. There was no difference between patients receiving IVT (n = 57) vs supportive care (n = 50) regarding symptom onset, early ischemic changes, perfusion mismatch, or admission NIHSS score (all p > 0.05). In IVT-treated patients, the presence of an occlusion was an independent predictor of a favorable morphologic response (FIV/CBF: β -1.43; 95% confidence interval [CI] -1.96, -0.83; p = 0.001) and functional outcome (90-day modified Rankin Scale: odds ratio 7.68; 95% CI 4.33-11.51; p = 0.039; ∆NIHSS: odds ratio 5.76; 95% CI 3.98-8.27; p = 0.013), while it did not predict outcome in patients receiving supportive care (all p > 0.05). In stroke patients with negative CTA, distal vessel occlusions as detected by waveletCTA are an independent predictor of a favorable response to IVT.

Comparative safety and efficacy of combined IVT and MT with direct MT in large vessel occlusion.

In this multicenter study, we sought to evaluate comparative safety and efficacy of combined IV thrombolysis (IVT) and mechanical thrombectomy (MT) vs direct MT in emergent large vessel occlusion (ELVO) patients. Consecutive ELVO patients treated with MT at 6 high-volume endovascular centers were evaluated. Standard safety and efficacy outcomes (successful reperfusion [modified Thrombolysis in Cerebral Infarction IIb/III], functional independence [FI] [modified Rankin Scale (mRS) score of 0-2 at 3 months], favorable functional outcome [mRS of 0-1 at 3 months], functional improvement [mRS shift by 1-point decrease in mRS score]) were compared between patients who underwent combined IVT and MT vs MT alone. Additional propensity score-matched analyses were performed. A total of 292 and 277 patients were treated with combination therapy and direct MT, respectively. The combination therapy group had greater functional improvement (p = 0.037) at 3 months. After propensity score matching, 104 patients in the direct MT group were matched to 208 patients in the combination therapy group. IVT pretreatment was independently (p < 0.05) associated with higher odds of FI (odds ratio [OR] 1.75; 95% confidence interval [CI] 1.02-2.99) and functional improvement (common OR 1.64; 95% CI 1.05-2.56). Combination therapy was independently (p < 0.05) related to lower likelihood of 3-month mortality (0.50; 95% CI 0.26-0.96). This observational study provides preliminary evidence that IVT pretreatment may improve outcomes in ELVO patients treated with MT. The question of the potential effect of IVT on ELVO patients treated with MT should be addressed with a randomized controlled trial. This study provides Class III evidence that for stroke patients with emergent large vessel occlusion, combined IVT and MT is superior to direct MT in improving functional outcomes.

Intravenous thrombolysis and platelet count.

To study the effect of platelet count (PC) on bleeding risk and outcome in stroke patients treated with IV thrombolysis (IVT) and to explore whether withholding IVT in PC < 100 × 109/L is supported. In this prospective multicenter, IVT register-based study, we compared PC with symptomatic intracranial hemorrhage (sICH; Second European-Australasian Acute Stroke Study [ECASS II] criteria), poor outcome (modified Rankin Scale score 3-6), and mortality at 3 months. PC was used as a continuous and categorical variable distinguishing thrombocytopenia (<150 × 109/L), thrombocytosis (>450 × 109/L), and normal PC (150-450 × 109/L [reference group]). Moreover, PC < 100 × 109/L was compared to PC ≥ 100 × 109/L. Unadjusted and adjusted odds ratios (ORs) with 95% confidence intervals (CIs) from the logistic regression models were calculated. Among 7,533 IVT-treated stroke patients, 6,830 (90.7%) had normal PC, 595 (7.9%) had thrombocytopenia, and 108 (1.4%) had thrombocytosis. Decreasing PC (every 10 × 109/L) was associated with increasing risk of sICH (ORadjusted 1.03, 95% CI 1.02-1.05) but decreasing risk of poor outcome (ORadjusted 0.99, 95% CI 0.98-0.99) and mortality (ORadjusted 0.98, 95% CI 0.98-0.99). The risk of sICH was higher in patients with thrombocytopenic than in patients with normal PC (ORadjusted 1.73, 95% CI 1.24-2.43). However, the risk of poor outcome (ORadjusted 0.89, 95% CI 0.39-1.97) and mortality (ORadjusted 1.09, 95% CI 0.83-1.44) did not differ significantly. Thrombocytosis was associated with mortality (ORadjusted 2.02, 95% CI 1.21-3.37). Forty-four (0.3%) patients had PC < 100 × 109/L. Their risks of sICH (ORunadjusted 1.56, 95% CI 0.48-5.07), poor outcome (ORadjusted 1.63, 95% CI 0.82-3.24), and mortality (ORadjusted 1.38, 95% CI 0.64-2.98) did not differ significantly from those of patients with PC ≥ 100 × 109/L. Lower PC was associated with increased risk of sICH, while higher PC indicated increased mortality. Our data suggest that PC modifies outcome and complications in individual patients, while withholding IVT in all patients with PC < 100 × 109/L is challenged.

Fibrin Clot Architecture in Acute Ischemic Stroke Treated With Mechanical Thrombectomy With Stent-Retrievers - Cohort Study.

The composition of intra-arterial clots might influence the efficacy of mechanical thrombectomy (MT) in ischemic stroke (IS) due to the acute occlusions within large cerebral arteries. The aims were to assess the factors associated with blood clot structure and the impact of thromboembolus structure on MT using stent-retrievers in patients with acute large artery IS in the anterior circulation.Methods and Results:In an observational cohort study, we studied the components of intra-arterial clots retrieved from large cerebral arteries in 80 patients with acute IS treated with MT with or without i.v. thrombolysis (IVT). Histology of the clots was carried out without knowledge of the clinical findings, including the treatment methods. The components of the clots, their age, origin and semi-quantitative graded changes in the architecture of the fibrin components (e.g., "thinning") were compared via neuro-interventional, clinical and laboratory data. The most prominent changes in the architecture of the fibrin components in the thromboemboli were associated with IVT (applied in 44 patients; OR, 3.50; 95% CI: 1.21-10.10, P=0.02) and platelet count (OR, 2.94; 95% CI: 1.06-8.12, P=0.04). In patients with large artery IS treated with the MT using stent-retrievers, bridging therapy with IVT preceding MT and higher platelet count were associated with significant changes of the histological structure of blood clots.

Outcome after stroke thrombolysis in patients >80 years treated within 3 hours vs >3-4.5 hours.

To determine outcomes and risks of IV thrombolysis (IVT) in patients with acute ischemic stroke (AIS) >80 years of age within 3 hours compared to >3 to 4.5 hours recorded in the Safe Implementation of Treatment in Stroke (SITS) International Stroke Thrombolysis Registry. A total of 14,240 (year 2003-2015) patients >80 years of age with AIS were treated with IVT ≤4.5 hours of stroke onset (3,558 in >3-4.5 hours). Of these, 8,658 (2,157 in >3-4.5 hours) were treated otherwise according to the European Summary of Product Characteristics (EU SmPC) criteria for alteplase. Outcomes were 3-month functional independence (modified Rankin Scale score 0-2), mortality, and symptomatic intracerebral hemorrhage (SICH)/SITS. Results were compared between the groups treated in >3 to 4.5 and ≤3 hours. Median age was 84 years; 61% were female in both groups. Median NIH Stroke Scale score was 12 vs 14 in the >3- to 4.5- and ≤3-hour group, respectively. Three-month functional independence was 34% vs 35% (adjusted odds ratio [aOR] 0.78, 95% confidence interval [CI] 0.69-0.89, p < 0.001); mortality was 31% vs 32% (aOR 1.10, 95% CI 0.97-1.25, p = 0.13); and SICH/SITS was 2.7% vs 1.6% (aOR 1.72, 95% CI 1.25-2.35, p = 0.001). In EU SmPC-compliant patients, 3-month functional independence was 36 vs 37% (aOR 0.79, 95% CI 0.68-0.92, p = 0.002), mortality was 29% vs 29.6% (aOR 1.10, 95% CI 0.95-1.28, p = 0.20), and SICH/SITS was 2.7% vs 1.6% (aOR 1.62, 95% CI 1.12-2.34, p = 0.01). In this observational study, unselected patients >80 years of age treated with IVT after 3 hours vs earlier had a slightly higher rate of SICH and similar unadjusted functional outcome but poorer adjusted outcome. The absolute difference between the treatment groups is small, and elderly patients should not be denied IVT in the later time window solely because of age without other contraindications.

Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice.

Background and Purpose Standard operating procedures (SOP) incorporating plasma levels of rivaroxaban might be helpful in selecting patients with acute ischemic stroke taking rivaroxaban suitable for IVthrombolysis (IVT) or endovascular treatment (EVT).MethodsThis was a single-center explorative analysis using data from the Novel-Oral-Anticoagulants-in-Stroke-Patients-registry (clinicaltrials.gov:NCT02353585) including acute stroke patients taking rivaroxaban (September 2012 to November 2016). The SOP included recommendation, consideration, and avoidance of IVT if rivaroxaban plasma levels were <20 ng/mL, 20‒100 ng/mL, and >100 ng/mL, respectively, measured with a calibrated anti-factor Xa assay. Patients with intracranial artery occlusion were recommended IVT+EVT or EVT alone if plasma levels were ≤100 ng/mL or >100 ng/mL, respectively. We evaluated the frequency of IVT/EVT, door-to-needle-time (DNT), and symptomatic intracranial or major extracranial hemorrhage.Results Among 114 acute stroke patients taking rivaroxaban, 68 were otherwise eligible for IVT/EVT of whom 63 had plasma levels measured (median age 81 years, median baseline National Institutes of Health Stroke Scale 6). Median rivaroxaban plasma level was 96 ng/mL (inter quartile range [IQR] 18‒259 ng/mL) and time since last intake 11 hours (IQR 4.5‒18.5 hours). Twenty-two patients (35%) received IVT/EVT (IVT n=15, IVT+EVT n=3, EVT n=4) based on SOP. Median DNT was 37 (IQR 30‒60) minutes. None of the 31 patients with plasma levels >100 ng/mL received IVT. Among 14 patients with plasma levels ≤100 ng/mL, the main reason to withhold IVT was minor stroke (n=10). No symptomatic intracranial or major extracranial bleeding occurred after treatment.Conclusions Determination of rivaroxaban plasma levels enabled IVT or EVT in one-third of patients taking rivaroxaban who would otherwise be ineligible for acute treatment. The absence of major bleeding in our pilot series justifies future studies of this approach.

Diurnal Variation of Intravenous Thrombolysis Rates for Acute Ischemic Stroke and Associated Quality Performance Parameters.

Based on data from the Baden-Wuerttemberg stroke registry, we aimed to explore the diurnal variation of acute ischemic stroke (IS) care delivery. 92,530 IS patients were included, of whom 37,471 (40%) presented within an onset-to-door time ≤4.5 h. Daytime was stratified in 3-h time intervals and working vs. non-working hours. Stroke onset and hospital admission time, rate of door-to-neurological examination time ≤30 min, onset-/door-to-imaging time IV thrombolysis (IVT) rates, and onset-/door-to-needle time were determined. Multivariable regression models were used stratified by stroke onset and hospital admission time to assess the relationship between IVT rates, quality performance parameters, and daytime. The time interval 0:00 h to 3:00 h and working hours, respectively, were taken as reference. The IVT rate of the whole study population was strongly associated with the sleep-wake cycle. In patients presenting within the 4.5-h time window and potentially eligible for IVT stratification by hospital admission time identified two time intervals with lower IVT rates. First, between 3:01 h and 6:00 h (IVT rate 18%) and likely attributed to in-hospital delays with the lowest diurnal rate of door-to-neurological examination time ≤30 min and the longest door-to-needle time Second, between 6:01 h and 15:00 h (IVT rate 23-25%) compared to the late afternoon and evening hours (IVT rate 27-29%) due to a longer onset-to-imaging time and door-to-imaging time. No evidence for a compromised stroke service during non-working hours was observed. The analysis provides evidence that acute IS care is subject to diurnal variation which may affect stroke outcome. An optimization of IS care aiming at constantly high IVT rates over the course of the day therefore appears desirable.

First-line use of contact aspiration for thrombectomy versus a stent retriever for recanalization in acute cerebral infarction: The randomized ASTER study protocol.

Rationale Mechanical thrombectomy with a stent retriever is now the standard of care in anterior circulation ischemic stroke caused by large vessel occlusion. New techniques for mechanical thrombectomy, such as contact aspiration, appear promising to increase reperfusion status and improve clinical outcome. Aim We aim at ascertaining whether contact aspiration is more efficient than the stent retriever as a first-line endovascular procedure. Sample size estimates With a two-sided test (alpha = 5%, power = 90%) and an anticipated rate of spontaneous recanalization and catheterization failures of 15%, we estimate that a sample size of 380 patients will be necessary to detect an absolute difference of 15% in primary outcome (superiority design). Methods and design The ASTER trial is a prospective, randomized, multicenter, controlled, open-label, blinded end-point clinical trial. Patients admitted with suspected ischemic anterior circulation stroke secondary to large vessel occlusion, with onset of symptoms <6 h, will be randomly assigned to contact aspiration or stent retriever in a 1:1 ratio; stratified by center and prior IV thrombolysis. If the assigned treatment technique is not successful after three attempts, another technique will be applied, at the operator's discretion. Study outcomes The primary outcome will be successful recanalization (modified Thrombolysis in Cerebral Infarction score 2b-3) at the end of the endovascular procedures. Secondary outcome will include successful recanalization after the assigned first-line treatment technique alone, procedural times, the need for a rescue technique, complications and modified Rankin Scale at three months. Discussion No previous head to head randomized trials have directly compared contact aspiration versus stent retriever reperfusion techniques. This prospective trial aims to provide further evidence of benefit of contact aspiration versus stent retriever techniques among patients with ischemic stroke.

Abstract TMP22: Thrombus Volume as Predictor of Successful Recanalization in the Acute Stroke Patients With Thrombolytic Treatment

Introduction: The prediction of non-recanalization after IV thrombolysis (IVT) may be helpful to avoid unnecessary treatment and determine the strategy of recanalization treatment. Thrombus volume and density can be measured using software, which may provide accurate and reliable information on thrombus characteristics. Hypothesis: We hypothesized that the thrombus volume and/or density could predict non-recanalization after IVT. Methods: This was a post-hoc analysis of prospective cohort who underwent thin-section noncontrast CT (1 or 1.25 mm) and recanalization therapy. Among them, this study considered patients who received IVT due to anterior circulation stroke from Nov. 2006 to Dec. 2015. The volume and density of thrombus were measured semi-automatically using 3-dimensional software. Recanalization was assessed on CT angiography at the end of IVT or conventional angiography in cases further treated with intra-arterial treatment. Successful recanalization was defined as arterial occlusive lesion grade 2 or 3. Results: Among 345 patients considered, 218 with visible thrombus in the intracranial arteries were included for this study. Successful recanalization was achieved in 79 patients (36.2%). Thrombus volume was significantly larger in patients with non-recanalization than those with successful recanalization (median [interquartile range]: 117.8mm 3 [60.0 - 216.8 mm 3 ] vs. 56.9 mm 3 [31.1 - 105.0 mm 3 ]. p&lt;0.001). In the multivariate analysis, thrombus volume was independently associated with non-recanalization (p&lt;0.001). Recanalization failed in all cases with thrombus &gt; 300 mm 3 , and in 41 of 44 cases (93.2%) with thrombus &gt; 200 mm 3 . Thrombus density did not differ between the groups (non-recanalization vs. successful recanalization: 54.0 ± 9.1 vs. 52.6 ± 8.5, p=0.263). Conclusions: Thrombus volume was predictive of non-recanalization after IVT. Measurements of thrombus volume may be helpful to determine the strategy of recanalization treatment.

Outcome and Treatment Effects in Stroke Associated with Acute Cervical ICA Occlusion.

BackgroundEndovascular therapy (EVT) with stent retrievers in addition to i.v. thrombolysis (IVT) has proven effective in acute stroke patients with middle cerebral artery (MCA, M1 segment) and distal internal carotid artery (ICA) occlusion. Limited data exist concerning acute cervical ICA occlusion, either alone or in combination with intracranial ICA occlusion (tandem occlusion). Therefore we analyzed outcome and treatment effects in stroke associated with cervical ICA occlusion, with specific focus on the impact of intracranial ICA or M1 patency.MethodsSeventy-eight patients with cervical ICA occlusion from our local stroke unit registry were analyzed retrospectively. Thrombolysis in Cerebral Infarction (TICI) classification, infarct size, modified Rankin scale (mRS), symptomatic intracerebral hemorrhage (ICH), and death were assessed as outcome parameters.ResultsForty-three patients had isolated cervical ICA occlusion whereas 35 patients presented with extra-/intracranial tandem occlusion. Patients underwent IVT alone (n = 23), combined IVT/EVT (n = 28) or no treatment (n = 27). Treated and untreated patients with tandem occlusion had a worse outcome after 90 days compared to isolated cervical occlusion (OR for moderate outcome 0.29, 0.27–0.88, p = 0.01). Additional EVT improved outcome in patients with tandem occlusion (OR for moderate outcome: 15.43, 1.60–148.90, p = 0.008) but not isolated cervical occlusion (OR 1.33, 0.38–11.60, NS).ConclusionsIn contrast to tandem occlusion, stroke outcome in patients with isolated cervical ICA occlusion was generally more benign and not improved by combined IVT/EVT compared to IVT alone. Intracranial vessel patency may be critical for treatment decision in acute cervical ICA occlusion.

Mechanical thrombectomy in patients with medical contraindications for intravenous thrombolysis: a prospective observational study

Background and purposeThe present study was conducted with the objective of evaluating the safety of primary mechanical thrombectomy (MT) in patients with large vessel occlusion (LVO) stroke and comorbidities that...