P5594Comparison of non-vitamin K antagonist oral anticoagulants versus vitamin K antagonist on changes in pulmonary vascular resistance in patients with chronic thromboembolic pulmonary hypertension

Abstract

Abstract Background/Introduction Chronic thromboembolic pulmonary hypertension (CTEPH) requires a lifelong anticoagulation therapy. However, the efficacy or safety of non-vitamin K antagonist oral anticoagulants (NOACs) have not been established in CTEPH. Purpose We aimed to evaluate the effects of NOACs on the changes in pulmonary vascular resistance (PVR) and their adverse events such as bleeding and clinical worsening in CTEPH. Methods We retrospectively compared the changes in PVR among CTEPH patients taking vitamin-K antagonists (VKA) (n=38) and those taking NOACs (n=46) to evaluate the effectiveness of NOACs for the prophylaxis of thrombotic disease progression in CTEPH. Also, we extracted incidence of clinically relevant bleeding and clinical worsening in CTEPH as an exploratory outcome measures. Clinical worsening in CTEPH was defined as composite outcome of death from any cause, lung transplantation and worsening pulmonary hypertension that resulted in hospitalization, addition of specific drug for pulmonary hypertension, or rescue pulmonary endarterectomy or balloon pulmonary angioplasty. Clinically relevant bleeding was defined as composite major bleeding and/or clinically relevant non-major bleeding, which is defined as bleeding associated with the need for medical intervention, contact with a physician, interruption of anticoagulation therapy, discomfort or impairment of activities of daily life. Results The changes in PVR (VKA group; −0.17±0.82 woods unit/year, NOACs group; −0.44±0.89 woods unit/year, p=0.32) were comparable between VKA and NOACs groups. The incidence of clinical worsening in CTEPH (VKA group; 1.8% per patient-year, NOACs group; 0% per patient-year) and clinically relevant bleeding (VKA group; 2.8% per patient-year, NOACs group; 2.8% per patient-year) was comparable between the VKA and NOACs groups. D-dimer levels (VKA group; 0.58±0.22 μg/ml, NOACs group; 0.67±0.47 μg/ml, p=0.41) were also comparable between the groups. Conclusions Our study revealed that NOACs had a similar effectiveness in the prevention of thrombotic disease progression in CTEPH as compared with VKA. The result suggest that NOACs might have similar efficacy and safety as VKA in daily clinical practice. Acknowledgement/Funding Japan Agency for Medical Research and Development