Clinical and Economic Outcomes in Low-risk Pulmonary Embolism Patients Treated with Rivaroxaban versus Standard of Care.

BACKGROUND

Rivaroxaban, a fixed-dose oral direct factor Xa inhibitor, does not require continuous monitoring and thus reduces the hospital stay and economic burden in low-risk pulmonary embolism (LRPE) patients. Study Question: What is the effectiveness of rivaroxaban versus the standard of care (SOC; low-molecular-weight heparin, unfractionated heparin, warfarin) among LRPE patients in the Veterans Health Administration?

STUDY DESIGN

Adult patients with continuous health plan enrollment for ≥12 months pre- and 3 months post-inpatient PE diagnosis (index date=discharge date) between October 1, 2011-June 30, 2015 and an anticoagulant claim during the index hospitalization were included.

MEASURES AND OUTCOMES

Patients scoring 0 points on the simplified Pulmonary Embolism Stratification Index were considered low-risk and were stratified into SOC and rivaroxaban cohorts. Propensity score matching (PSM) was used to compare hospital-acquired complications (HACs), PE-related outcomes (recurrent venous thromboembolism, major bleeding, and death), and healthcare utilization and costs between the rivaroxaban and SOC cohorts.

RESULTS

Among 6746 PE patients, 1918 were low-risk; of these, 73 were prescribed rivaroxaban, 1546 were prescribed SOC, and 299 were prescribed other anticoagulants during the index hospitalization. After 1:3 PSM, 64 rivaroxaban and 192 SOC patients were included. During the index hospitalization, rivaroxaban users (versus SOC) had similar inpatient length of stay (LOS; 7.0 vs 6.7 days, standardized difference [STD]=1.8) but fewer HACs (4.7% vs 10.4%; STD: 21.7). In the 90-day post-discharge period, PE-related outcome rates were similar between the cohorts (all p>0.05). However, rivaroxaban users had fewer outpatient (15.9 vs 20.4; p=0.0002) visits per patient as well as lower inpatient ($765 vs $2,655; p<0.0001), pharmacy ($711 vs $1,086; p=0.0033), and total costs ($6,270 vs $9,671; p=0.0027).

CONCLUSIONS

LRPE patients prescribed rivaroxaban had similar index LOS and PE-related outcomes, but fewer HACs, and lower total costs than those prescribed SOC.

Déclaration de conflit d'intérêts

CONFLICT OF INTEREST DISCLOSURE: WFP has received grants from Abbott, Alere, Banyan, Cardiorentis, Janssen, Portola, Pfizer, Roche, and ZS Pharma; is a consultant to Alere, Beckman, Boehringer-Ingelheim, Cardiorentis, Instrument Labs, Janssen, Phillips, Portola, Prevencio, Singulex, The Medicine’s Company, and ZS Pharma; and also has ownership interests at the Comprehensive Research Associate LLC, Emergencies in Medicine LLC. CIC has received grant funding and consulting fees from Janssen Scientific Affairs, LLC, Raritan, NJ and Bayer Pharma AG, Berlin, Germany. PW receives speaker fees from Bayer Healthcare and Daiichi Sankyo, writing committee fees from Itreas, and grant support fees from Pfizer/BMS. [ORCID number 000-0002-8657-8326] GJF has received research support from Novartis, Siemens, Pfizer, Portola, and PCORI; has advised Janssen Scientific Affairs, LLC; and receives speaker fees from Janssen. CC and JS are employees of Janssen Scientific Affairs. LW is an employee of STATinMED Research, which is a paid consultant to Janssen Scientific Affairs. OB has no conflicts to declare.