Abstract Number: LPB0041
Meeting: ISTH 2021 Congress
Background: Guidelines recommend low molecular weight heparins (LMWHs) or factor-Xa-inhibitors for >3 months in patients with cancer-associated venous thromboembolism (CAT).
Aims: We studied patient satisfaction with anticoagulant treatment, which may be essential for the choice of drug and anticoagulation adherence.
Methods: CONKO-011, is an open-label, prospective study approved by ethics committees in patients with symptomatic CAT randomized after informed consent to center-specific LMWHs or rivaroxaban. Patient satisfaction with anticoagulant treatment was measured by the Anti-Clot Treatment Scale (ACTS). The 12-item ACTS Burdens scale (primary endpoint after 4 weeks) and the 3-item ACTS Benefits scale were analysed at 4, 8 and 12 weeks; clinical outcome parameters for up to week 24.
Results: 247 patients were randomized. Characteristics were well balanced (Table 1). At 4 weeks the relative range of ACTS Burdens and Benefits Scores with rivaroxaban were 88% (53/60) and 77% (12/15), respectively. Mean ACTS Burdens scores after 4 weeks were 52.8 versus 51.2 in favour of rivaroxaban (p=0.006) with mean score differences ranging from 3.3 (week 8; p=0.001) to 2.4 (week 12; p=0.006). As result from multivariate longitudinal variance analysis, treatment effect of ACTS burden was consistent over treatment time (p<0.001). The ACTS Benefits scores were in favor of rivaroxaban at 4 (p=0.042) and 8 (p=0.055) weeks, but not at 12 (p=0.546) weeks. More patients on LMWH requested to stop study treatment preterm (19.4% versus 11.1%). There were 8 and 15 SAE >4° in the rivaroxaban and LMWH groups, respectively. Venous and arterial thromboembolic as well as major bleeding events did not differ between groups (Table 2).
|Age (mean ± SD) / male (n)||64.47 ± 10.91 / 58||62.94 ± 11.35 / 64|
|Weight [kg] (mean ± SD)||75.71 ± 18.20||78.43 ± 16.95|
|Index-VTE Distal DVT||29.6 %||29.0 %|
|Proximal DVT||9.6 %||10.5 %|
|Pulmonary embolism||37.6 %||35.5 %|
|Cancer Loco-regional||31.2 %||29.8 %|
|Metastasized||68.8 %||70.2 %|
|Anti-cancer therapy||87.2 %||86.3 %|
|Preterm stop of study medication||39.5 %||43.1 %|
|„Patient´s request“||19.4 %||11.1 %|
|Cancer related death||8.9 %||12.2 %|
|Major bleeding||0.8 %||0.0 %|
|Severe adverse events >3° (SAE; n)||59||50|
|Recurrent VTE [rVTE] (n)||5||3|
|rVTE + Myocardial infarction + Stroke (n)||4||5|
|Major bleeding (n)||5||5|
|Clinically relevant non-major bleeding (n)||5||13|
Conclusions: The CONKO-011 trial comparing real-life use of different LMWHs to rivaroxaban in CAT patients supports (i) an improved patient reported treatment satisfaction with rivaroxaban, particularly in reducing anticoagulation-related burden, resulting in less patient requested treatment stops and (ii) a balanced risk-benefit relation for rivaroxaban compared with LMWH.
To cite this abstract in AMA style:Riess H, Sinn M, Lohneis A, Hellmann M, Striefler J, Südhoff T, Pelzer U, Stahl M, Schlenska-Lange A, Krziwanie A, Trappe R, Rutzner S, Heinz J, Wernecke K-. Improved Patient-reported Treatment Satisfaction with Rivaroxaban as Compared to Low Molecular Weight Heparins for Cancer Patients with Acute Venous Thromboembolism – Results from the CONKO-011 Trial [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/improved-patient-reported-treatment-satisfaction-with-rivaroxaban-as-compared-to-low-molecular-weight-heparins-for-cancer-patients-with-acute-venous-thromboembolism-results-from-the-conko-011-trial/. Accessed November 30, 2023.
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