Safety and efficacy of intra-arterial fibrinolytics as adjunct to mechanical thrombectomy: A systematic review and meta-analysis of observational data

Background: Achieving the best possible reperfusion is a key determinant of clinical outcome after mechanical thrombectomy (MT). However, data on the safety and efficacy of intra-arterial (IA) fibrinolytics as an adjunct to MT with the intention to improve reperfusion are sparse. Methods: We performed a PROSPERO-registered (CRD42020149124) systematic review and meta-analysis accessing MEDLINE, PubMed, and Embase from January 1, 2000 to January 1, 2020. A random-effect estimate (Mantel-Haenszel) was computed and summary OR with 95% CI were used as a measure of added IA fibrinolytics versus control on the risk of symptomatic intracranial hemorrhage (sICH) and secondary endpoints (modified Rankin Scale ≤2, mortality at 90 days). Results: The search identified six observational cohort studies and three observational datasets of MT randomized-controlled trial data reporting on IA fibrinolytics with MT as compared with MT alone, including 2797 patients (405 with additional IA fibrinolytics (100 urokinase (uPA), 305 tissue plasminogen activator (tPA)) and 2392 patients without IA fibrinolytics). Of 405 MT patients treated with additional IA fibrinolytics, 209 (51.6%) received prior intravenous tPA. We did not observe an increased risk of sICH after administration of IA fibrinolytics as adjunct to MT (OR 1.06, 95% CI 0.64 to 1.76), nor excess mortality (0.81, 95% CI 0.60 to 1.08). Although the mode of reporting was heterogeneous, some studies observed improved reperfusion after IA fibrinolytics. Conclusion: The quality of evidence regarding peri-interventional administration of IA fibrinolytics in MT is low and limited to observational data. In highly selected patients, no increase in sICH was observed, but there is large uncertainty

O-005 Influence of Balloon, Conventional, or Distal Catheters on Angiographic and Technical Outcomes in STRATIS

Introduction/purposeHigher rates of successful revascularization with the least number of passes correlate with improved clinical outcomes in acute stroke endovascular treatment. Different adjunctive technical approaches such as proximal flow arrest using balloon guide catheter (BGC), large bore conventional guide catheter (CGC), or distal large bore catheter (DLBC) with lesional or regional aspiration, are aimed at improving revascularization rates. We present an interim analysis of adjunctive techniques and angiographic outcomes from the STRATIS Registry.Materials and methodsThe STRATIS registry is a prospective, multicenter study of patients with large vessel occlusion (LVO) treated with the Solitaire Stentriever ≤8 hours of symptoms onset. Technical approaches were grouped based on the first technique implemented: BGC; CGC; and DLBC. Posterior circulation target vessel occlusion and subjects with combined BGC and DLBC approach were excluded. A Core Lab extrapolated the techniques from the procedural reports. Baseline variables were compared between the three groups. The main angiographic and technical outcomes were: 1) First pass effect (FPE) defined as successful recanalization of ≥TICI2b, 2) True FPE defined as TICI 3 after first pass with Solitaire; 3) Number of passes among the cohorts.Results413 anterior circulation subjects were included in this interim analysis. The initial technical approach was 60% BGC, 30% DLBC, and 10% CGC. The groups were well balanced in reference to baseline and demographic factors. The rates of FPE were: 62%, 51%, and 45% (P = 0.0336), while the true FPE rates were: 44% vs. 37% vs. 28% (P = 0.0996) with BGC, DLBC, and CGC, respectively. The mean number of passes were: 1.7 ± 1.09, 2.1 ± 1.42, and 2.2 ± 1.76 (P = 0.0085), with BGC, DLBC, and CGC, respectively. The rates of successful recanalization of ≥TICI2b after all passes were 91.9% BGC, 88.8% DLBC, and 87.5% CGC (P = 0.4945).ConclusionThe STRATIS registry interim analysis demonstrated a higher use of BGC as first approach (60%) compared to previous reports. Consistent with published data, BGC is associated with higher rates of successful revascularization and a trend toward higher rates of complete revascularization from the first pass. Moreover, a lower number of passes is associated with BGC use compared to CGC and DLBC. DLBC with lesional and regional aspiration appears to be superior to CGC only. These results are preliminary, and further analysis with final planned sample size and correlation with central blinded core lab imaging data will provide further evidence on technical and angiographic outcomes with different adjunctive approaches.DisclosuresO. Zaidat: 2; C; Medtronic Neurovascular. D. Liebeskind: 1; C; NIH-NINDS. 2; C; Medtronic Neurovascular, Stryker. R. Jahan: 1; C; Medtronic Neurovascular. 2; C; Medtronic Neurovascular. M. Froehler: 2; C; Medtronic Neurovascular. 6; C; Site PI (Large, Liberty, SCENT, Feat, Barrel, Atlas, Rhapsody, Positive, Sep 3D) payment to institution. M. Aziz-Sultan: 2; C; Medtronic Neurovascular. 6; C; Expert Witness - BMC. R. Klucznik: 3; C; Medtronic Neurovascular. J. Saver: 2; C; Medtronic Neurovascular, Stryker, Neuravia, Cognition Medical, Boehringer Ingelheim (prevention only). D. Yavagal: 2; C; Medtronic Neurovascular. 6; C; ESCAPE trial DSCMB member. N. Mueller-Kronast: 2; C; Medtronic Neurovascular

5 Mechanical thrombectomy in acute ischemic stroke patients with low alberta stroke program early computed tomography scores

Background and purposeLimited data exists on the benefit of mechanical thrombectomy (MT) in acute ischemic stroke patients presenting with low ASPECTS (Alberta Stroke Program Early Computed Tomography (CT) Score). The aim of this substudy was investigate the outcome of low ASPECTS (0–5) patients undergoing mechanical thrombectomy in the Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke (STRATIS) Registry.MethodsData from the STRATIS Registry, a prospective, multicenter, non-randomized, observational study of AIS LVO patients treated with the Solitaire stent-retriever as the first choice therapy within 8 hours from symptoms onset, was used to identify patients with baseline ASPECTS 0–5. CT ASPECTS was adjudicated by a core lab blinded to clinical outcomes.ResultsA total of 57/763 (7.5%) patients had a baseline ASPECTS 0–5, of which 10 were ASPECTS 0–3 and 47 ASPECTS 4–5. Mean baseline NIHSS was 19.9±5.1. The majority of patients presented with ICA (42.1%) and M1 (47.4%) occlusions. IV-rtPA was administered in 68.4%. Mean onset to arterial puncture was 276±102.9 minutes and puncture to reperfusion time was 45.3±25.3 minutes. The majority of patients (85.5%) achieved substantial reperfusion (mTICI≥2b). Ninety-day outcome was reported in 52/57 (91.2%). The rate of good functional outcome (mRS≤2) was 28.8% (versus 59.7% in ASPECTS 6–10 group, p<0.001), which is higher than the 14.1% reported in the control arm 0–5 in the HERMES pooled analysis. Symptomatic intracranial hemorrhage and mortality rates were 7.0% and 30.8%, respectively. When further dichotomizing the group to ASPECTS 0–3 and 4–5 to determine the cut-off for MT futility, the rate of good outcome was 10% and 33.3%, respectively. In investigating the interaction between age and ASPECTS 0–5, low ASPECTS patients older than 75 had a lower rate of good clinical outcome than those 65–75 and less than 65 (0%, 18.2%, 44.8%).ConclusionIn the STRATIS Registry, low ASPECTS 0–5 is associated with lower functional outcomes in patients undergoing mechanical thrombectomy. Clinical outcome in low ASPECTS may be age dependent. Prospective studies are needed to understand the benefit of MT in this patient population.DisclosuresO. Zaidat: None. D. Liebeskind: None. A. Jadhav: None. S. Ortega-Gutierrez: None. V. Szeder: None. D. Haussen: None. D. Yavagal: None. M. Froehler: None. R. Jahan: None. T. Yao: None. N. Mueller-Kronast: None

Abstract Number ‐ 38: Outcome Predictors in Posterior Circulation Stroke After Mechanical Thrombectomy: Pooled Analysis from NASA and TRACK

Introduction Recent randomized clinical trials have demonstrated that endovascular therapy for basilar artery occlusion is safe and effective. However, many people still have poor outcomes despite treatment. The aim of this study was to identify the predictors of good functional outcome in posterior circulation strokes after mechanical thrombectomy from the Trevo Stent‐Retriever Acute Stroke TRACK and the North American Solitaire Stent Retriever Acute Stroke (NASA) registries. Methods Patient‐level data from the TRACK and NASA registries were pooled and patients with posterior circulation stroke were included in the analysis. Patients were dichotomized into those with 90‐day good functional outcome (mRS≤2) and poor functional outcome (mRS>2). Baseline and procedural data were compared between the two cohorts. Multivariate logistic regression was then performed to identify predictors of functional outcome. P‐value < 0.05 was considered significant. Results Out of 119 posterior stroke patients (99 BA, 16 VA, and 4 PCA), a total of 110 patients had mRS data available on follow‐up. Good functional outcome was observed in 44 patients (37%). Patients with mRS≤2 were less likely to have hypertension (61.4% versus 83.3%, p = 0.01), dyslipidemia (38.6% versus 62.1%, p = 0.016), and diabetes (18.2% versus 36.4%, p = 0.040). Patients with mRS≤2 had a lower mean baseline NIHSS (15.2±9.95 versus 22.6±9.50, p< .001). Time to puncture, utilization of BGC, general anesthesia use, number of passes, and successful recanalization (TICI≥ 2B) were not significantly different between the two cohorts. On multivariate analysis, higher baseline NIHSS was associated with worse functional outcome (OR:0.91, CI:0.87‐0.96, P< .001). Use of IV tPA was associated with higher odds of achieving good functional outcomes (OR:2.82, CI:1.06‐7.51, P:0.038). Conclusions In this pooled analysis of the NASA and TRACK Registries, posterior circulation patients achieving good outcome were more likely to have a lower baseline NIHSS and less comorbidities. Use of IV‐tPA and lower baseline NIHSS were independent predictors of functional outcome

Impact of Age and Alberta Stroke Program Early Computed Tomography Score 0 to 5 on Mechanical Thrombectomy Outcomes: Analysis From the STRATIS Registry

Background and Purpose: This study investigates clinical outcomes after mechanical thrombectomy in adult patients with baseline Alberta Stroke Program Early CT Score (ASPECTS) of 0 to 5. Methods: We included data from the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) from patients who underwent mechanical thrombectomy within 8 hours of symptom onset and had available ASPECTS data adjudicated by an independent core laboratory. Angiographic and clinical outcomes were collected, including successful reperfusion (modified Thrombolysis in Cerebral Infarction ≥2b), functional independence (modified Rankin Scale score 0–2), 90-day mortality, and symptomatic intracranial hemorrhage at 24 hours. Outcomes were stratified by ASPECTS scores and age. Results: Of the 984 patients enrolled, 763 had available ASPECTS data. Of these patients, 57 had ASPECTS of 0 to 5 with a median age of 63 years (interquartile range, 28–100), whereas 706 patients had ASPECTS of 6 to 10 with a median age of 70 years of age (interquartile range, 19–100). Ten patients had ASPECTS of 0 to 3 and 47 patients had ASPECTS of 4 to 5 at baseline. Successful reperfusion was achieved in 85.5% (47/55) in the ASPECTS of 0 to 5 group. Functional independence was achieved in 28.8% (15/52) in the ASPECTS of 0 to 5 versus 59.7% (388/650) in the 6 to 10 group ( P 75 years with ASPECTS of 0 to 5 (0/12) achieved functional independence versus 44.8% (13/29) of those age ≤65 ( P =0.005). Conclusions: Patients 75 years of age. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02239640