The efficacy and safety of Batroxobin in combination with anticoagulation on cerebral venous sinus thrombosis

Abstract

Cerebral venous sinus thrombosis (CVST) is an uncommon subtype of stroke with highly variable clinical presentation. Although anticoagulation with heparin and/or warfarin remains the standard treatment for CVST, treatment failure is still common. This study aims to evaluate the safety and efficacy of Batroxobin in combination with anticoagulation on CVST control. In this retrospective study, a total of 61 CVST patients were enrolled and divided into Batroxobin (n = 23) and control (n = 38) groups. In addition to the same standard anticoagulation in control, patients in the treatment group received Batroxobin 5 BU intravenous infusion (10 BU for the first time) every other day, for a total of three infusions. A higher recanalization rate was found in Batroxobin group (adjusted OR [95% CI] of 2.5 [1.1-5.0], p = 0.028) compared to the control group, especially in patients with high levels of fibrinogen (adjusted OR [95% CI] of 4.7 [1.4-16.7], p = 0.015). Statistically significant differences between the two groups were seen regarding the levels of thrombin time, fibrinogen and D-dimer at each cut-off time point (all p < 0.01). Compared with baseline, NIHSS scores at discharge showed significant improvement in the Batroxobin group [0(0, 4.25)-5(2, 11), p = 0.036]. No significant difference in mRS scores was found between the two groups at discharge or at 6-month outpatient follow-up (all p > 0.05). Additionally, Batroxobin did not increase the risk of intracranial hemorrhage. We conclude that Batroxobin is a potentially safe and effective adjunct therapeutic agent promoting CVST recanalization especially in patients with high level of fibrinogen.

Batroxobin in combination with anticoagulation may promote venous sinus recanalization in cerebral venous thrombosis: A real‐world experience

“…NIHSS scores and mRS scores at discharge and 6 months were equivalent between the patients with batroxobin use and controls in the previous study. Only discharge NIHSS scores were significantly better in batroxobin group . The current study revealed no significant differences in NIHSS or mRS at follow‐up.…”

“…The MRBTI map gave us direct visualization of clot elimination with nonionizing radiation suggesting this may be a new noninvasive accurate way of following CVT patients. The elevation of D‐dimer (more than 20‐fold of baseline) and reduction in fibrinogen after batroxobin use presented in the previous study provide a convincing demonstration that fibrinolysis and thrombolysis induced by batroxobin can dissolve CVT thrombus …”

“…Among the patients with normal fibrinogen, batroxobin in combination with anticoagulation still exhibited more benefit than anticoagulation alone. Although we cannot perform comparisons among patients with high fibrinogen levels, the recent study showed the important role of batroxobin in CVT with high fibrinogen levels . The stenosis improvement rates on MRBTI maps were more remarkable in the batroxobin group compared to the control group.…”

“…In the batroxobin group, all patients underwent intravenous batroxobin after signed an informed consent [batroxobin injection (produced by Beijing Tuobixi Pharmaceutical Co., Ltd., the approval number was H20031074) 10 BU for the first time, followed by 5 BU every other day, for two times, unless the level of fibrinogen dropped to 1.0 g/L or less]. The paradigm aforementioned was also depicted in our previously published study …”

“…It is a defibrinogenating agent which is more commonly used on cerebral arterial thrombosis . A recent study revealed that batroxobin in combination with anticoagulation may be safe and effective for reducing fibrinogen in cerebral venous circulation and promoting thrombolysis . The authors of the previous study utilized time‐of‐flight magnetic resonance venography (TOF MRV) in patients who underwent intravenous batroxobin plus anticoagulation, the study identified batroxobin as a promising agent in CVT control.…”