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Randomized Controlled Trial
. 2024 Apr 3;106(7):590-599.
doi: 10.2106/JBJS.23.00824. Epub 2024 Feb 21.

Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial

Collaborators, Affiliations
Randomized Controlled Trial

Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial

Nathan N O'Hara et al. J Bone Joint Surg Am. .

Abstract

Background: Current guidelines recommend low-molecular-weight heparin for thromboprophylaxis after orthopaedic trauma. However, recent evidence suggests that aspirin is similar in efficacy and safety. To understand patients' experiences with these medications, we compared patients' satisfaction and out-of-pocket costs after thromboprophylaxis with aspirin versus low-molecular-weight heparin.

Methods: This study was a secondary analysis of the PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT) trial, conducted at 21 trauma centers in the U.S. and Canada. We included adult patients with an operatively treated extremity fracture or a pelvic or acetabular fracture. Patients were randomly assigned to receive 30 mg of low-molecular-weight heparin (enoxaparin) twice daily or 81 mg of aspirin twice daily for thromboprophylaxis. The duration of the thromboprophylaxis, including post-discharge prescription, was based on hospital protocols. The study outcomes included patient satisfaction with and out-of-pocket costs for their thromboprophylactic medication measured on ordinal scales.

Results: The trial enrolled 12,211 patients (mean age and standard deviation [SD], 45 ± 18 years; 62% male), 9725 of whom completed the question regarding their satisfaction with the medication and 6723 of whom reported their out-of-pocket costs. The odds of greater satisfaction were 2.6 times higher for patients assigned to aspirin than those assigned to low-molecular-weight heparin (odds ratio [OR]: 2.59; 95% confidence interval [CI]: 2.39 to 2.80; p < 0.001). Overall, the odds of incurring any out-of-pocket costs for thromboprophylaxis medication were 51% higher for patients assigned to aspirin compared with low-molecular-weight heparin (OR: 1.51; 95% CI: 1.37 to 1.66; p < 0.001). However, patients assigned to aspirin had substantially lower odds of out-of-pocket costs of at least $25 (OR: 0.15; 95% CI: 0.12 to 0.18; p < 0.001).

Conclusions: Use of aspirin substantially improved patients' satisfaction with their medication after orthopaedic trauma. While aspirin use increased the odds of incurring any out-of-pocket costs, it protected against costs of ≥$25, potentially improving health equity for thromboprophylaxis.

Level of evidence: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

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Conflict of interest statement

Disclosure: This study was funded by the Patient-Centered Outcomes Research Institute (PCS-1511-32745 and DI-2022C3-29701). The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article ( http://links.lww.com/JBJS/H893 ).

Figures

Fig. 1
Fig. 1
CONSORT (Consolidated Standards of Reporting Trials) flowchart. NSAIDS = nonsteroidal anti-inflammatory drugs.
Fig. 2
Fig. 2
Patient satisfaction with their thromboprophylactic medication stratified by treatment group. LMWH = low-molecular-weight heparin.
Fig. 3
Fig. 3
Variation in the effect of aspirin versus low-molecular-weight heparin (LMWH) thromboprophylaxis on patient satisfaction with the medication by type of health insurance. CI = confidence interval.
Fig. 4
Fig. 4
Patient-reported out-of-pocket thromboprophylactic medication costs stratified by treatment group. LMWH = low-molecular-weight heparin.
Fig. 5
Fig. 5
Variation in the effect of aspirin versus low-molecular-weight heparin (LMWH) thromboprophylaxis on any out-of-pocket costs (versus no out-of-pocket costs) and on out-of-pocket costs of ≥$25 (versus <$25) by type of health insurance. CI = confidence interval.

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