Abstract Number: PB2477
Meeting: ISTH 2020 Congress
Background: XALIA and XALIA-LEA were prospective non-interventional studies observing treatment and secondary prevention of venous thromboembolism (VTE) across global regions. This pooled analysis combined the study datasets.
Aims: To explore the safety and effectiveness of rivaroxaban and standard anticoagulation (heparin/fondaparinux, usually overlapping with and followed by a vitamin K antagonist [VKA]) for VTE treatment in routine clinical practice, with further focus on quality control of treatment with VKAs and genitourinary bleeding patterns.
Methods: Adult patients with confirmed deep vein thrombosis or pulmonary embolism and an indication for ≥3 months’ anticoagulation treatment received rivaroxaban or standard anticoagulation. Treatment type, dose and duration were at the physician’s discretion. Primary outcomes were major bleeding, recurrent VTE and all-cause mortality. Propensity score-stratification and -matching designs were used to reduce confounding bias. Regulators and study centres’ institutional review boards approved the protocol; written informed consent was obtained from all patients.
Results: Overall, 7129 patients were enrolled in 36 countries; the propensity score-stratified and -matched analyses included 6445 and 2714 patients, respectively. Major bleeding and recurrent VTE incidences were similar between treatment groups; all-cause mortality was lower with rivaroxaban than standard anticoagulation in both adjusted analyses (Table 1). Genitourinary bleeding incidences in the matched analysis (including prolonged menstrual bleeding) were higher with rivaroxaban than standard anticoagulation (46 events [4 major] versus 23 events [2 major]). VKA-treated patients showed marked variation in quality of international normalized ratio (INR) control (time in therapeutic range) (Table 2).
Conclusions: This supplemental pooled analysis provides the largest ‘real-world’ prospective dataset of rivaroxaban use for VTE treatment. Low major bleeding, recurrent VTE and all-cause mortality incidences supported the safety and effectiveness of rivaroxaban in a broad range of patients with VTE. However, the sites of bleeding were different between treatment groups and there was variation globally regarding quality of INR control.
|Propensity score-stratified analysis Outcome||Rivaroxaban (n=3902)||Standard anticoagulation (n=2543)||HR (95% CI)||p-value|
|n (%)||Events per 100 patient-years (95% CI)||n (%)||Events per 100 patient-years (95% CI)|
|Major bleeding||39 (1.00)||1.74 (1.24-2.38)||63 (2.48)||3.95 (3.03-5.05)||0.65 (0.39-1.08)||0.099|
|Recurrent VTE||55 (1.41)||2.47 (1.86-3.21)||71 (2.79)||4.49 (3.51-5.67)||0.85 (0.54-1.32)||0.460|
|All-cause mortality||41 (1.05)||1.83 (1.31-2.48)||117 (4.60)||7.28 (6.02-8.72)||0.55 (0.33-0.91)||0.021|
|Propensity score-matched analysis Outcome||Rivaroxaban (n=1357)||Standard anticoagulation (n=1357)||HR (95% CI)||p-value|
|Major bleeding||17 (1.25)||2.11 (1.23-3.38)||26 (1.92)||3.08 (2.01-4.52)||0.65 (0.35-1.20)||0.172|
|Recurrent VTE||21 (1.55)||2.62 (1.62-4.01)||27 (1.99)||3.23 (2.13-4.70)||0.79 (0.44-1.39)||0.412|
|All-cause mortality||19 (1.40)||2.36 (1.42-3.68)||34 (2.51)||4.00 (2.77-5.59)||0.55 (0.31-0.97)||0.039|
|CI, confidence interval; HR, hazard ratio; VTE, venous thromboembolism|
[Table 1. Treatment-emergent outcomes in the propensity score-stratified (top) and propensity score-matched (bottom) analysis sets]
|Treatment details||VKA (n=1944)|
|Initial heparin/fondaparinux||1586 (81.6)|
|No heparin/fondaparinux||358 (18.4)|
|Patients receiving VKA with available INR values||989 (50.9)|
|TTR, mean, % (SD)|
|INR <2.0||33.5 (39.3)|
|INR 2.0-3.0||53.5 (39.0)|
|INR >3.0||13.0 (25.5)|
|Data are n (%) unless stated otherwise. INR, international normalized ratio; SD, standard deviation; TTR, time in therapeutic range; VKA, vitamin K antagonist.|
[Table 2. Time in therapeutic range patterns in patients in the safety population receiving VKAs]
To cite this abstract in AMA style:Haas S, Mantovani LG, Kreutz R, Monje D, Schneider J, Zell E, Tamm M, Gebel M, Bugge J-, Ageno W, Turpie AGG. VTE Treatment in Routine Clinical Practice: A Pre-specified Combined Evaluation of XALIA and XALIA-LEA with Additional Analyses of Special Patient Populations [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/vte-treatment-in-routine-clinical-practice-a-pre-specified-combined-evaluation-of-xalia-and-xalia-lea-with-additional-analyses-of-special-patient-populations/. Accessed January 23, 2022.
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