Key result
In patients with prosthetic valve thrombosis receiving thrombolysis, high INR levels were not associated with significant differences in major bleeding (P=0.809) or response to therapy (P=0.658).
Why the study?
Thrombolytic agents are guideline-recommended for many patients with prosthetic valve thrombosis, but the safety of thrombolytic therapy in patients presenting with high INR levels required assessment.
Does thrombolytic therapy increase bleeding complications or alter efficacy in patients with prosthetic heart valve thrombosis who have high INR levels compared to subtherapeutic levels?
Cohort (n=65)
No
Does thrombolytic therapy increase bleeding complications or alter efficacy in patients with prosthetic heart valve thrombosis who have high INR levels compared to subtherapeutic levels?
p-value: p=0.809 for major bleeding
Thrombolytic therapy for prosthetic valve thrombosis does not appear to have significantly different bleeding risks or efficacy in patients with high versus subtherapeutic INR levels.
High INR should not guide thrombolysis decisions in prosthetic valve thrombosis; hypothesis-generating and requires prospective confirmation.
BACKGROUND AND AIM: Prosthetic valve thrombosis (PVT) is a rare but life-threatening complication of heart valve replacement. Based on the current guidelines, the treatment of a large number of these patients could be performed through the administration of thrombolytic agents. In the present study, we aim to assess the safety of thrombolytic therapy in patients with PVT who have high international normalized ratio (INR) levels. METHODS: In this study, we retrospectively analyzed outcomes of thrombolytic therapy in 65 PVT patients with different levels of INR at the time of fibrinolysis at a tertiary cardiac center. RESULTS: Mean age of patients was 51.6 ± 12.47 years. The tricuspid valve was the most common site of prosthetic valve thrombosis (64.6%). The Median (range) of INR was 2.1 (0.9-4.9). The majority of patients (50.8%) achieved a complete response following thrombolytic treatment. There were no cases of intracranial hemorrhage. Other major and minor bleedings occurred in 3 (4.6%) and 10 (15.4%) patients, respectively. No embolic stroke and systemic embolism were observed. We found no significant difference in the frequency of major (P-value = .809) and minor (P-value = .483) bleeding as well as response to thrombolytic therapy (P-value = .658) between patients with different levels of INR. Total administered dose of Streptokinase was also similar in PVT patients with or without major (P-value = .467) and minor (P-value = .221) bleeding complications. CONCLUSIONS: We concluded that there was no significant difference between PVT patients presenting with subtherapeutic and high INR levels who received thrombolytic treatments regarding both minor and major bleeding complications as well as response to thrombolysis.
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Farzaneh et al. (2020) conducted a cohort in Prosthetic valve thrombosis (PVT) (n=65). High international normalized ratio (INR) levels vs. Subtherapeutic INR levels was evaluated on Major bleeding, minor bleeding, and response to thrombolytic therapy (p=0.809 for major bleeding). In patients with prosthetic valve thrombosis receiving thrombolysis, high INR levels were not associated with significant differences in major bleeding (P=0.809) or response to therapy (P=0.658).
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