Initial anticoagulation therapy with direct oral anticoagulants in patients with intermediate-high-risk pulmonary embolism: from the COMMAND VTE Registry-2

Abstract Background Patients with intermediate-high-risk pulmonary embolism (PE) who have both right ventricular dysfunction and elevated cardiac biomarkers are at a high risk of early hemodynamic decompensation and circulatory collapse, and it might be reasonable to treat these patients with parenteral anticoagulation therapy before switching to oral anticoagulation therapy. Recently, initial direct oral anticoagulants (DOACs) therapy in patients with PE have been shown to be non-inferior compared with initial parenteral anticoagulation therapy followed by vitamin K antagonist, which might be also a potential alternative for patients with intermediate-high-risk PE. However, the effectiveness and safety of initial DOACs therapy in this patient population have not been well investigated. Methods The COMMAND VTE Registry-2 is a multicenter registry enrolling 5197 consecutive acute symptomatic venous thromboembolism (VTE) patients among 31 Japanese medical centers in the DOAC era between January 2015 and August 2020. The current study population consisted of 515 patients with intermediate-high-risk PE who were normotensive and right ventricular dysfunction on echocardiography or computed tomography, accompanied by elevated troponin levels (troponin I >0.028 ng/mL or troponin T >0.014 ng/mL) or N-terminal pro-B-type natriuretic peptide (NT-proBNP)/B-type natriuretic peptide (BNP) levels (NT-proBNP ≥600 pg/mL or BNP ≥100 pg/mL). The patients were divided into 2 groups; patients with initial DOACs therapy (N=107) and those with initial parenteral anticoagulation therapy (N=408). Results Most of baseline characteristics were comparable between the 2 groups. The 1-year cumulative incidence of bleeding events was significantly lower in patients with initial DOACs therapy than in those with initial parenteral anticoagulation therapy (6.5% vs. 15.3%, P=0.007) (Figure 1A), whereas the 1-year cumulative incidence of VTE recurrence was comparable between the 2 groups (2.2% vs. 2.2%, P=0.62) (Figure 1B). The 1-year incidence of all-cause mortality was numerically lower in patients with initial DOACs therapy than in those with initial parenteral anticoagulation therapy without statistically significant difference (4.5% vs. 13.5%, P=0.06) (Figure 1C). Conclusions Initial DOACs therapy in patients with intermediate-high-risk PE showed no signal of worse outcomes compared with initial parenteral anticoagulation therapy, which could be a potential initial anticoagulation strategy in this patient population.Figure 1