Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke

Chen, Hui‐Sheng; Cui, Yu; Zhou, Zhonghe; Dai, Ying-Jie; Li, Gao-hua; Peng, Zhaolong; Zhang, Yi; Liu, Xiaodong; Yuan, Zhi-Mei; Jiang, Chang-Hao; Yang, Qingcheng; Duan, Ying-Jie; Ma, Guang-Bin; Zhao, Lu; Wang, Ruixian; Sun, Yuanlin; Shen, Lei; Wang, Er-Qiang; Wang, Lihua; Feng, Ye-Fang; Wang, Fengyun; Zou, Ren-Lin; Yang, Heping; Wang, Kai; Wang, Duolao; Wang, Yilong

doi:10.1001/jama.2023.0550

Cited by 31 publications

(36 citation statements)

References 25 publications

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“…Due to the excessive hemorrhage transformation rates associated with conventional anticoagulants, most efforts to reduce END have focused on novel anticoagulants combined with antiplatelet therapies. No harmful profile of argatroban was observed even in patients who received intravenous alteplase, suggesting the possible safety of anticoagulants . In our study, a combined regimen of antiplatelet and argatroban in patients with END did not increase the risk of symptomatic intracerebral hemorrhage and severe systemic bleeding, which is in line with previous studies …”

Section: Discussionsupporting

confidence: 91%

Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration

Zhang,

Zhong,

Xue

et al. 2024

JAMA Neurol

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ImportanceThe effect of argatroban in patients with acute ischemic stroke (AIS) and early neurological deterioration (END) is unknown.ObjectiveTo assess the efficacy of argatroban for END in AIS.Design, Setting, and ParticipantsThis open-label, blinded–end point, randomized clinical trial was conducted from April 4, 2020, through July 31, 2022. The date of final follow-up was October 31, 2022. This was a multicenter trial. Eligible patients were adults with AIS who experienced END, which was defined as an increase of 2 or more points on the National Institutes of Health Stroke Scale within 48 hours from symptom onset. Patients who withdrew consent, experienced duplicate randomization, or were lost to follow-up were excluded from the study.InterventionsPatients were randomly assigned to the argatroban group and control group within 48 hours of symptom onset. Both groups received standard therapy based on guidelines, including oral mono or dual antiplatelet therapy. The argatroban group received intravenous argatroban for 7 days (continuous infusion at a dose of 60 mg per day for 2 days, followed by 20 mg per day for 5 days) in addition to standard therapy.Main Outcome and MeasureThe primary end point was good functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 3.ResultsA total of 628 patients (mean [SD] age, 65 [11.9] years; 400 male [63.7%]) were included in this study (argatroban group, 314 [50%] and control group, 314 [50%]). Of these, 18 withdrew consent, 1 had duplicate randomization, and 8 were lost to follow-up. A total of 601 patients with stroke were included in the intention-to-treat analysis. Finally, 564 patients were included in the per-protocol analysis as 6 participants in the argatroban group and 31 participants in the control group did not follow the complete protocol. The number of patients with good functional outcome at 90 days was 240 (80.5%) in the argatroban group and 222 (73.3%) in the control group (risk difference, 7.2%; 95% CI, 0.6%-14.0%; risk ratio, 1.10; 95% CI, 1.01-1.20; P = .04). The proportion of symptomatic intracranial hemorrhage was 3 of 317 (0.9%) in the argatroban group and 2 of 272 (0.7%) in the control group (P = .78).Conclusions and RelevanceAmong patients with AIS with END, treatment with argatroban and antiplatelet therapy resulted in a better functional outcome at 90 days. This trial provided evidence to support the use of argatroban in reducing disability for patients with END.Trial RegistrationClinicalTrials.gov Identifier: NCT04275180

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Section: Discussionsupporting

confidence: 91%

Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration

Zhang,

Zhong,

Xue

et al. 2024

JAMA Neurol

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“…Previous studies on the use of argatroban in AIS used National Institutes of Health Stroke Scale (NIHSS) score [16,24]. To our knowledge, no correlation study has used MESSS score to evaluate the effect of argatroban in the treatment of AIS.…”

Section: Discussionmentioning

confidence: 99%

“…Chen et al (2018) [16] demonstrated that argatroban has no additional benefit on short-term outcomes compared to high-dose aspirin alone. A recent study reported that argatroban is safe but does not improve functional outcome at 90 days in Chinese patients with AIS treated with recombinant tissue-type plasminogen activator (r-tPA) [24]. A meta-analysis concluded that patients with AIS might not benefit from the combined therapy with argatroban [14].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Prognosis of Adjuvant Argatroban Treatment in Acute Ischemic Stroke Patients with Early Neurological Deterioration

Xu¹,

Zhang²,

Zhang³

et al. 2023

Discovery Medicine

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Background: The therapeutic outcomes for acute ischemic stroke (AIS) with early neurological deterioration (END) are adverse. Argatroban is a novel direct thrombin inhibitor, which is safe in the treatment of AIS, but its efficacy is controversial. This study sought to assess the therapeutic effect of argatroban as an adjunct to aspirin in the treatment of AIS patients with END. Patients' prognosis for the presence of END was also evaluated. Methods: Overall, 166 AIS patients with END were included in the study from June 2018 to June 2021 in The Affiliated Zhangjiagang Hospital of Soochow University. Patients were divided in the control group (aspirin alone) and the study group (aspirin combined with argatroban). General data of the patients were collected. Clinical indexes such as the modified Edinburgh-Scandinavian stroke scale (MESSS), and the serum fibrinogen (FIB) and neuropeptide Y (NPY) levels before and after treatment were also collected. Correlations between prognosis and general data, and FIB and NPY levels in AIS patients with END were analyzed by multivariate logistic regression. The performance of FIB and NPY levels in predicting patients' prognosis was further analyzed using receiver operating characteristic (ROC) curves. Results: There was no significant difference in the general data, such as sex, age, course of disease and basic diseases between the 2 groups. After treatment, the MESSS score (13.08 ± 3.24 vs. 16.48 ± 3.32, p < 0.001), serum FIB level (2.72 ± 0.81 vs. 3.52 ± 0.71, p < 0.001), and NPY level (121.28 ± 17.34 vs. 152.09 ± 18.25, p < 0.001) of the study group was significantly lower than that of the control group. A further analysis revealed that the serum FIB (OR, odds ratio = 2.296, 95% confidence interval, CI: 1.437-3.669, p = 0.001) and NPY (OR = 1.020, 95% CI: 1.002-1.039, p = 0.031) levels were independent risk factors of patients' prognosis for the presence of END. Conclusions: Aspirin combined with argatroban significantly improved neurological impairment of AIS patients with END, which is worthy of clinical application.

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“…However, ARAMIS (Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke) recently confirmed the findings of PRISMS, favoring dual antiplatelet therapy in a similar population. 14 ARAMIS showed that the same direction of effect favoring antiplatelet therapy using a modified Rankin scale, albeit nonsignificantly, reduces the likelihood that a more sensitive measure, such as cognition, would detect a treatment effect in the opposite direction. We are still determining whether patients at higher risk for disability or deterioration, such as those with LVO or perfusion deficits, would benefit from IVT.…”

Section: Treatment Eligibility: Beyond Timementioning

confidence: 99%

Intravenous Thrombolysis to Dissolve Acute Stroke Thrombi: Reflections on the Past Decade

Aziz,

Khatri

2024

Stroke

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Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke

Cited by 31 publications

References 25 publications

Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration

Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration

Efficacy and Prognosis of Adjuvant Argatroban Treatment in Acute Ischemic Stroke Patients with Early Neurological Deterioration

Intravenous Thrombolysis to Dissolve Acute Stroke Thrombi: Reflections on the Past Decade

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