In patients with active cancer and venous thromboembolism, whether extended treatment with a reduced dose of an oral anticoagulant is effective in preventing recurrent thromboembolic events and decreasing bleeding is unclear. We conducted a randomized, double-blind, noninferiority trial with blinded central outcome adjudication. Consecutive patients with active cancer and proximal deep-vein thrombosis or pulmonary embolism who had completed at least 6 months of anticoagulant therapy were randomly assigned in a 1:1 ratio to receive oral apixaban at a reduced (2.5 mg) or full (5.0 mg) dose twice daily for 12 months. The primary outcome was centrally adjudicated fatal or nonfatal recurrent venous thromboembolism, assessed in a noninferiority analysis (margin of 2.00 for the upper boundary of the 95% confidence interval of the subhazard ratio). The key secondary outcome was clinically relevant bleeding, assessed in a superiority analysis. A total of 1766 patients underwent randomization at a median time since the index event of 8.0 months (interquartile range, 6.5 to 12.6); 866 patients were assigned to the reduced-dose group, and 900 to the full-dose group. The median treatment duration was 11.8 months (interquartile range, 8.3 to 12.1). Recurrent venous thromboembolism occurred in 18 patients (cumulative incidence, 2.1%) in the reduced-dose group and in 24 (cumulative incidence, 2.8%) in the full-dose group (adjusted subhazard ratio, 0.76; 95% confidence interval [CI], 0.41 to 1.41; P = 0.001 for noninferiority). Clinically relevant bleeding occurred in 102 patients (cumulative incidence, 12.1%) in the reduced-dose group and in 136 (cumulative incidence, 15.6%) in the full-dose group (adjusted subhazard ratio, 0.75; 95% CI, 0.58 to 0.97; P = 0.03). Mortality was 17.7% in the reduced-dose group and 19.6% in the full-dose group (adjusted hazard ratio, 0.96; 95% CI, 0.86 to 1.06). Extended anticoagulation with reduced-dose apixaban was noninferior to full-dose apixaban for the prevention of recurrent venous thromboembolism in patients with active cancer. The reduced dose led to a lower incidence of clinically relevant bleeding complications than the full dose. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; API-CAT ClinicalTrials.gov number, NCT03692065.).

The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment. Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient’s opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm. For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications. The international randomized HOME-PE study demonstrates that, for triaging patients with acute pulmonary embolism for home treatment, the Hestia rule and the simplified Pulmonary Embolism Severity Index, complemented by the physician's overruling, are equally safe and efficient.

Introduction: Direct oral anticoagulants (DOACs) have shown non-inferiority and ease of use compared to vitamin K antagonists (VKA) in the treatment of venous thromboembolism (VTE). No study so far has been directed toward real-life experience of outpatients receiving anticoagulants for VTE in France. Methods: This is an observational descriptive real-life epidemiological study, using three validated questionnaires (Morisky Medication Adherence Scale-8, EQ-5D, and part 2 of the Perception of Anticoagulant Treatment Questionnaire), to assess adherence, quality of life, and satisfaction in 100 VTE outpatients receiving anticoagulation therapy by VKA (primary or switched from DOAC to VKA) or by DOAC (primary or switched from VKA to DOAC). Results: Patients were very much satisfied with their treatment in both DOAC and VKA groups. Despite advantages of DOACs, therapeutic adherence was only moderate. The best adherence scores were observed in the primary VKA switched to DOAC for at least 3 months (S-DOAC) subgroup. Quality of life was better in the DOAC group mainly because of the absence of the requirement for blood testing. Most of the complaints concerned the pain/discomfort dimension in the VKA group and anxiety/depression dimension in the DOAC group. Conclusion: Patients were satisfied with their anticoagulant treatment, especially when they were involved in choosing the anticoagulant, and the treatment suited them. Quality of life of patients in the DOAC group was better than in the VKA group, but adherence remains to be improved. This study highlights the importance of the physician–patient relationship, pretreatment initiation, and follow-up of any anticoagulation therapy throughout.