Intra-arterial tenecteplase following endovascular therapy in patients with acute posterior circulation arterial occlusion: study protocol and rationale.

BACKGROUND: Recently, a randomized controlled trial showed a beneficial effect of intra-arterial thrombolysis following successful endovascular thrombectomy (EVT) in patients with acute ischemic stroke due to large vessel occlusion in the anterior circulation. Due to differences in response to thrombolytics in occlusion of the posterior circulation, the purpose of ATTENTION IA is to explore the adjunct benefit of intra-arterial thrombolysis after successful recanalization in patients presenting with large and medium vessel occlusion of the posterior circulation. METHODS: ATTENTION-IA is an investigator-initiated, multicenter, prospective, randomized clinical trial with open-label treatment and blinded endpoint assessment (PROBE). After achieving successful recanalization (expanded Thrombolysis In Cerebral Infarction (eTICI) 2b-3) of an occlusion of the vertebral, basilar, or posterior cerebral artery, patients will be randomized 1:1 to receive intra-arterial tenecteplase or standard of care. The primary effect parameter is a modified Rankin Score of 0-1 at day 90. RESULTS: The trial recently completed enrollment, and data collection/verification is ongoing. The final results will be made available on completion of enrollment and follow-up. CONCLUSIONS: ATTENTION-IA will provide definitive evidence for the efficacy and safety of adjunct intra-arterial tenecteplase after successful EVT in patients with an acute posterior circulation arterial occlusion stroke presenting within 24 hours of symptom onset. TRIAL REGISTRATION: ClinicalTrials.gov NCT05684172.

Anesthetic Management and Outcomes of Endovascular Treatment of Basilar Artery Occlusion: Results From the ATTENTION Registry.

BACKGROUND AND PURPOSE: To examine the clinical and safety outcomes after endovascular treatment (EVT) for acute basilar artery occlusion (BAO) with different anesthetic modalities. METHODS: This was a retrospective analysis using data from the Endovascular Treatment for Acute Basilar Artery Occlusion (ATTENTION) registry. Patients were divided into two groups defined by anesthetic modality performed during EVT: general anesthesia (GA) or non-general anesthesia (non-GA). The association between anesthetic management and clinical outcomes was evaluated in a propensity score matched (PSM) cohort and an inverse probability of treatment weighting (IPTW) cohort to adjust for imbalances between the two groups. RESULTS: Our analytic sample included 1,672 patients from 48 centers. The anesthetic modality was GA in 769 (46.0%) and non-GA in 903 (54.0%) patients. In our primary analysis with the PSM-based cohort, non-GA was comparable to GA concerning the primary outcome (adjusted common odds ratio [acOR], 1.01; 95% confidence interval [CI], 0.82 to 1.25; P=0.91). Mortality at 90 days was 38.4% in the GA group and 35.8% in the non-GA group (adjusted risk ratio, 0.95; 95% CI, 0.83 to 1.08; P=0.44). In our secondary analysis with the IPTW-based cohort, the anesthetic modality was significantly associated with the distribution of modified Rankin Scale at 90 days (acOR: 1.45 [95% CI: 1.20 to 1.75]). CONCLUSION: In this nationally-representative observational study, acute ischemic stroke patients due to BAO undergoing EVT without GA had similar clinical and safety outcomes compared with patients treated with GA. These findings provide the basis for large-scale randomized controlled trials to test whether anesthetic management provides meaningful clinical effects for patients undergoing EVT.

Effect of routine inflammatory markers on clinical outcomes in acute basilar artery occlusion after endovascular thrombectomy: Results from ATTENTION registry.

BACKGROUND: To investigate the relationship between clinical routine inflammatory markers, including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), mean platelet volume (MPV), white blood cell count (WBC), neutrophils, lymphocytes, and platelets with clinical outcomes in acute basilar artery occlusion (BAO) patients receiving endovascular treatment (EVT). METHODS: We recruited 2134 acute BAO patients from 48 stroke centers across 22 Chinese provinces in the ATTENTION registry from 2017 to 2021. Blood samples were drawn at admission. An unfavorable functional outcome was defined using a modified Rankin Scale (mRS) of 4-6 at 90 days. Safety outcomes included mortality within 90 days and symptomatic intracerebral hemorrhage within 3 days. RESULTS: A total of 1044 patients were included in the final study. After adjusting for confounding factors, the upper quartiles of WBC and NLR were related to 90-day unfavorable functional outcome (mRS = 4-6) compared with those in the lowest quartile (WBC: quartile 4, odds ratio (OR) = 1.85, 95% confidence interval (CI) = 1.22-2.80; NLR: quartile 4, OR = 2.02, 95% CI = 1.34-3.06). The higher quartiles of WBC and NLR were also related to the increased risk of mortality at 90 days. Restricted cubic spline regression analysis showed an incremental trend between NLR and 90-day unfavorable functional outcome (Pnonlinearity = 0.055). In subgroup analysis, a significant interaction was found between NLR and bridging therapy for predicting unfavorable functional outcome (P = 0.006). CONCLUSION: Higher WBC and NLR on admission are significantly related to unfavorable functional outcome and mortality at 90 days in acute BAO patients receiving EVT. Significant interaction was found between increased NLR and bridging therapy on these outcome measures.

Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion.

BACKGROUND: Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).

Endovascular treatment for acute basilar artery occlusion: A multicenter randomized controlled trial (ATTENTION).

BACKGROUND AND HYPOTHESIS: Recently, two multicenter randomized controlled trials (RCT) failed to show a significantly beneficial effect of endovascular treatment (EVT) in patients with acute basilar artery occlusion (BAO). However, both trials suffered from equipoise issues which may have hindered the validity of the trial results. Therefore, additional RCT studies are needed to explore the potential benefit of EVT in patients presenting with BAO. STUDY DESIGN: ATTENTION is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial with open-label treatment and blinded outcome assessment (PROBE) of EVT versus best medical management (BMM). The primary effect parameter is a modified Rankin Score of 0-3 at day 90. DISCUSSION: ATTENTION will provide evidence for the efficacy and safety of EVT in stroke patients within 12 h after BAO. TRIAL REGISTRATION: ClinicalTrials.gov NCT04751708.

Association between tirofiban monotherapy and efficacy and safety in acute ischemic stroke.

BACKGROUND: Studies have suggested that glycoprotein IIb/IIIa antagonists such as tirofiban are beneficial for patients with acute coronary syndromes. However, it is still uncertain about the efficacy and safety of tirofiban in patients with acute ischemic stroke (AIS). METHODS: In this prospective non-randomized study, 255 AIS patients were recruited from 4 comprehensive stroke centers in China between January, 2017 and May, 2018. Among them,169 patients were treated with aspirin plus clopidogrel and 86 patients were treated with tirofiban. The primary functional outcome was the distribution of the 90 days' modified Rankin Scale (mRS). The safety outcomes included the incidence of intracranial hemorrhage (ICH) at discharge and mortality at 3 months. RESULTS: In the propensity score matched cohort, tirofiban alone was noninferior to the dual antiplatelet with regard to the primary outcome (adjusted common odds ratio, 0.97; 95% confidence interval, 0.46 to 2.04; P = 0.93). Mortality at 90 days was 10% in the dual antiplatelet group and 8% in the tirofiban group (adjusted odds ratio 0.75; 95% CI 0.08 to 7.40, p = 0.81). There was no difference of the ICH rate between two groups (adjusted odds ratio 0.44; 95% CI 0.13 to 1.48, p = 0.18). In the inverse probability of treatment weighting-propensity score-adjusted cohort, similar differences were found for functional and safety outcomes. CONCLUSIONS: Our study suggested that tirofiban use appears to be safe as monotherapy in AIS treatment compared with common dual antiplatelet therapy, however, no improvement in functional outcomes was found. TRIAL REGISTRATION: Chinese clinical trial registry, ChiCTR2000034443 , 05/07/2020. Retrospectively registered.