Fibrinogen Level and Bleeding Risk During Catheter-Directed Thrombolysis Using Tissue Plasminogen Activator

Lee, Kevin; Istl, Alexandra C.; Dubois, Luc; DeRose, Guy; Forbes, Thomas L.; Wiseman, Daniele; Mujoomdar, Amol; Kribs, Stewart; Power, Adam

doi:10.1177/1538574415611234

Cited by 22 publications

(11 citation statements)

References 20 publications

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“…Even if adjuvant therapy was possible, and the procedure time tended to be shorter in CDT, CBT seemed to have the advantages of a lower CDT duration and rt-PA dosages than conventional CDT. Several studies have examined whether the risk factors for bleeding risk during CDT are related to the duration and dosages of CDT used [18,19]. Approximately one-half of patients with ALI did not require adjunctive CDT, and the present study supported the major potential advantage of CBT, which, if successful as a stand-alone treatment, obviates the requirement for CDT with a concomitant reduction in the risk of hemorrhagic complications.…”

Section: Discussionsupporting

confidence: 65%

Endovascular Revascularization Strategies Using Catheter-Based Thrombectomy Versus Conventional Catheter-Directed Thrombolysis for Acute Limb Ischemia

Gong¹,

He²,

Zhao³

et al. 2021

Preprint

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Background Acute limb ischemia (ALI) is an important clinical event threatening both life and the affected limbs, but the optimal treatment for ALI remains undefined. The aim of this study was to compare the safety and effectiveness of thrombectomy approaches via either catheter-based thrombectomy (CBT) or catheter-directed thrombolysis (CDT). Methods A total of 98 patients (mean age 69.7 years, 60 male) who underwent endovascular intervention for ALI from January 2015 to August 2018 were included. Of these, 57 were treated with primary CBT via a large-bore catheter, an AngioJet catheter or Rotarex catheter, and/or underwent low-dose CDT, and 41 were treated with primary CDT. The safety and effectiveness of CBT compared to conventional CDT and other various endovascular techniques were evaluated. Results More Rutherford IIb patients were treated with primary CBT (68.4%) than CDT (26.8%; P < .001). Patients who underwent primary CBT achieved a higher technical success rate than those who underwent primary CDT in a shorter procedure time (P < .001), whereas 42.1% of patients who underwent CBT did not need adjunctive CDT. The duration and dosage of adjunctive CDT in the CBT group were significantly decreased compared with those in the primary CDT group (both P < .001), and the CBT group achieved a shorter in-hospital length of stay (P < .001). Subgroup analysis revealed that patients treated with AngioJet and Rotarex catheters achieved slightly lower dosages, shorter CDT durations and shorter in-hospital stay lengths than those treated with large-bore catheters (P > .05). Clinical success was estimated to be achieved in 98.2% of patients who underwent CBT, which is similar to the 97.6% estimated in those who underwent primary CDT (P = 1.000), and this finding was similar among the CBT subgroups. Patients who underwent primary CBT had slightly fewer complications than those who underwent primary CDT (P = .059), especially minor complications (P = .036). The freedom from amputation at 6 and 12 months for CBT and CDT was assessed (93.0% vs 90.2% respectively, P = .625; 89.5% vs 82.5%, respectively, P = .34,). Comparable limb salvage was found for different techniques of large bore catheters, AngioJet catheters and Rotarex catheters. The Kaplan-Meier table analysis also showed similar limb salvage rates between groups. Conclusions Endovascular treatment of ALI with the use of catheter-based therapies is a safe and effective modality with similar safety and clinical outcome to conventional CDT alone, and this treatment modality overcomes the common shortcomings of CDT alone. Different CBT techniques have comparable efficacy but different adverse event profiles.

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Section: Discussionsupporting

confidence: 65%

Endovascular Revascularization Strategies Using Catheter-Based Thrombectomy Versus Conventional Catheter-Directed Thrombolysis for Acute Limb Ischemia

Gong¹,

He²,

Zhao³

et al. 2021

Preprint

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“…However, they also markedly increase the risk of bleeding [ 19 ]. In addition, emergency treatment of CVDs with t-PA greatly increases the risk of bleeding [ 20 ]. Therefore, there is an urgent need for safer and more effective drugs to replace current treatments.…”

Section: Discussionmentioning

confidence: 99%

Safety assessment of subtilisin QK in rats

Xiao

Gao³

et al. 2021

BMC Pharmacol Toxicol

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Background Subtilisin QK is a serine protease in the subtilisin family, and is fermented by Bacillus subtilis QK02. The fibrinolytic activity of subtilisin QK was measured by detecting low molecular weight degradation products using a spectrophotometric method developed by Japan Bio Science Laboratory Co., Ltd. Subtilisin QK powder can maintain its fibrinolytic activity for more than 24 months when it is stored at room temperature and protected from light. Our previous results showed that subtlisin QK directly degraded cross-linked fibrins in the fibrin plate assay and effectively inhibited thrombosis in the mouse thrombus model. The aim of this study was to determine the acute toxicity, potential subchronic toxicity, and safety pharmacology of subtilisin QK in Sprague–Dawley (SD) rats. Methods In the acute toxicity study, a single oral dose of 100,000 FU/kg was administered to 10 female and 10 male SD rats. In the 28-day subchronic toxicity, 60 female and 60 male SD rats were randomly assigned to four experimental groups (daily oral dose of 0, 2500, 7500 and 25,000 FU/kg). In the safety pharmacology study, 20 female and 20 male SD rats were randomly assigned to four experimental groups (single oral dose of 0, 500, 1500 and 5000 FU/kg). Results No death occurred and no adverse effects were observed in the acute toxicity study at a dose of 100,000 FU/kg. In the 28-day subchronic toxicity study, several hematological and blood biochemical parameters showed increases or decreases; however, due to the lack of a dose–response relationship, these differences were considered unrelated to treatment. In the safety pharmacology study, no adverse effects were observed on the central nervous of SD rats post-administration up to a dose of 5000 FU/kg subtilisin QK. Conclusion The results showed that oral consumption of subtilisin QK is of low toxicological concern. No adverse effects were observed at doses of 2500, 7500, and 25,000 FU/kg in the 28-day subchronic toxicity, and the no-observed-adverse-effect level (NOAEL) of subtilisin QK was 25,000 FU/kg.

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“…They showed a significantly higher rate of bleeding if the fibrinogen level was <150 mg/dL [ 16 ]. On the contrary, a study performed by Lee et al, which examined 49 procedures, found that there was no significant increased risk of bleeding in patients with fibrinogen levels less than 150 mg/dL, despite larger total doses of TPA and longer duration of therapy [ 17 ]. The prospective PURPOSE trial with 241 patients undergoing catheter-directed thrombolysis found that there was no statistically significant difference in major or minor bleeding in patients with fibrinogen >100 mg/dL or <100 mg/dL ( p = 0.108) [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

Practice Trends of Fibrinogen Monitoring in Thrombolysis

Kaufman

Kinney

Quencer

2018

JCM

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There is a lack of evidence or societal guidelines regarding the utility of fibrinogen monitoring during thrombolysis. The purpose of our study was to investigate the current use of monitoring fibrinogen levels during thrombolysis. A voluntary, anonymous online survey was sent to all physician members of the Society of Interventional Radiology, consisting of 23 questions related to practitioner demographics, thrombolysis protocol, and fibrinogen monitoring. There were 455 physician responses; 82% of respondents monitored fibrinogen levels during thrombolysis, of which 97% decreased or stopped tissue plasminogen activator based on the level. Self-reported estimates of significant bleeding events during thrombolysis were 1.86% in those who monitored fibrinogen and 1.93% in those who did not. Only 34% of all respondents report, in their clinical experience, having found low fibrinogen level to be correlated with bleeding events. There was no significant difference in self-reported major bleeding rates between practitioners who monitor and those who do not monitor fibrinogen. This high variability of clinical use of fibrinogen monitoring during catheter-directed thrombolysis is secondary to the paucity of scientific studies demonstrating its utility; further scientific investigation is needed to define the true utility of fibrinogen monitoring.

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Fibrinogen Level and Bleeding Risk During Catheter-Directed Thrombolysis Using Tissue Plasminogen Activator

Abstract: A fibrinogen level <1.5 g/L during thrombolysis was not associated with an increased bleeding risk. However, larger dose and longer duration of thrombolysis were associated with increased bleeding risk.

Cited by 22 publications

References 20 publications

Endovascular Revascularization Strategies Using Catheter-Based Thrombectomy Versus Conventional Catheter-Directed Thrombolysis for Acute Limb Ischemia

Endovascular Revascularization Strategies Using Catheter-Based Thrombectomy Versus Conventional Catheter-Directed Thrombolysis for Acute Limb Ischemia

Safety assessment of subtilisin QK in rats

Practice Trends of Fibrinogen Monitoring in Thrombolysis

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