Abstract

Abstract 1163

Background:

Rivaroxaban treatment for symptomatic venous thromboembolism does not require routine laboratory monitoring, dose adjustments, or bridging with a parenteral anticoagulant and thus has the potential to reduce patient treatment burden compared with standard of care. It is becoming increasingly important to consider the views of patients in treatment decisions to improve adherence and, consequently, health outcomes. We investigated patient-reported outcomes in the EINSTEIN PE study, a large, open-label, randomized trial of patients with acute symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis. This trial compared oral rivaroxaban with dose-adjusted enoxaparin overlapping with, and followed by, vitamin K antagonist (VKA) treatment.

Methods:

As part of the EINSTEIN PE study, 2397 patients from 7 countries (Canada, France, Germany, Italy, Netherlands, UK, and USA) were requested to complete a newly developed and validated measure of anticoagulation treatment satisfaction – the Anti-Clot Treatment Scale (ACTS) – at scheduled visits during treatment: Day 15, then at Months 1, 2, 3, 6, and 12. The ACTS consists of 2 scales: ACTS Burdens (12 items, scored on a 12–60 scale) and ACTS Benefits (3 items, scored on a 3–15 scale). The ACTS Burdens scale captures the negative aspects of patients' anticoagulation experience (e.g. hassle/inconvenience, worry/frustration, and activity limitations), whereas the ACTS Benefits scale records the positive aspects (e.g. confidence, reassurance, and satisfaction). For each scale, higher total scores indicate better acceptance. In addition, patients completed the Treatment Satisfaction Questionnaire for Medication version II (TSQM II) at Months 1, 3, 6, and 12, primarily as a validation benchmark for the ACTS scale. There are 4 TSQM II subscales (Effectiveness, Side-Effects, Convenience, and Global Satisfaction), all of which are scored on a 0–100 scale. A pre-specified repeated measures analysis, stratified by intended treatment duration, with time (visit) as the repeated measure factor, was used to compare ACTS Burdens and ACTS Benefits scores between treatment groups in the intention-to-treat population; the analysis was repeated for the 4 TSQM II subscales.

Results:

Patients reported a lower burden and a higher perceived benefit in the rivaroxaban with higher mean ACTS scores across visits (Table). Mean ACTS Burdens scores were 55.4 versus 51.9 for rivaroxaban and enoxaparin/VKA, respectively (p<0.0001), and mean ACTS Benefits scores were 11.9 versus 11.4, respectively (p<0.001), in favorof rivaroxaban. The ACTS Burdens scores had a consistent treatment effect over time, but the difference in ACTS Benefits scores between the groups was not constant over time and showed a greater difference at Month 2 and later time points. The TSQM II scores confirmed the greater patient-reported treatment satisfaction, with higher scores shown in patients treated with rivaroxaban in all 4 subscales; the Convenience subscale had the largest difference.

Table

EINSTEIN PE: patient-reported treatment satisfaction scores (least-squares means from pre-specified repeated measures analysis)

ScaleRivaroxabanEnoxaparin/VKAp-value
ScorenScoren
ACTS Burdens 55.4 1149 51.9 1134 <0.0001 
ACTS Benefits 11.9  11.4  <0.0001 
TSQM Effectiveness 73.3 1125 69.6 1107 <0.0001 
TSQM Side-Effects 86.6 816 82.3 809 <0.0001 
TSQM Convenience 81.6 1129 71.8 1111 <0.0001 
TSQM Global Satisfaction 80.7 1126 73.0 1109 <0.0001 
ScaleRivaroxabanEnoxaparin/VKAp-value
ScorenScoren
ACTS Burdens 55.4 1149 51.9 1134 <0.0001 
ACTS Benefits 11.9  11.4  <0.0001 
TSQM Effectiveness 73.3 1125 69.6 1107 <0.0001 
TSQM Side-Effects 86.6 816 82.3 809 <0.0001 
TSQM Convenience 81.6 1129 71.8 1111 <0.0001 
TSQM Global Satisfaction 80.7 1126 73.0 1109 <0.0001 
Conclusions:

Patients with acute symptomatic pulmonary embolism reported a lower burden, higher perceived benefits, and improved treatment satisfaction with rivaroxaban compared with enoxaparin/VKA. The improved convenience of treatment, as perceived by patients, may contribute to increased patient acceptance of and adherence to anticoagulant treatment, with consequently improved health outcomes.

Disclosures:

Prins:Bayer Healthcare: Consultancy, Honoraria. Bamber:Bayer Healthcare: Employment. Cano:Bayer Healthcare: Research Funding. Wang:Bayer Healthcare: Employment. Lensing:Bayer Healthcare: Employment.

Author notes

*

Asterisk with author names denotes non-ASH members.