Abstract
Venous thromboembolism (VTE) is highly prevalent in patients with cancer. Non-vitamin K antagonist oral anticoagulants (NOACs), directly targeting the enzymatic activity of thrombin or factor Xa, have been shown to be as effective as and safer than traditional anticoagulation for VTE prophylaxis in no-cancer patients. However, related studies that focused on the anticoagulation in cancer patients are lacked, and almost no net clinical benefit (NCB) analyses that quantified both VTE events and bleeding events have been addressed in this fragile population. Therefore, we aim to investigate this issue using a systematic review and NCB analysis. A comprehensive search of Medline, Embase, and Cochrane Library were performed for randomized controlled trials (RCTs) that reported the VTE events and major bleeding of NOACs and traditional anticoagulants in patients with or without cancer. Odds ratios (ORs) and 95% confidence intervals (CIs) of VTE and bleeding events were calculated using a random-effects model. The primacy outcome of narrow NCB was calculated by pooling ORs of VTE and major bleeding, with a weighting of 1.0. Similarly, the broad NCB was calculated by pooling ORs of VTE and clinically relevant bleeding. Heterogeneity was assessed through I2 test and Q statistic, and subgroup analyses were performed on the basis of different patients (VTE patients or acutely ill patients), comparators (vitamin-K antagonists or low-molecular-weight heparin), and follow-up duration (≤6 months or >6 months). Overall, 9 RCTs including 41,454 patients were enrolled, of which 2,902 (7%) were cancer patients, and 38,552 (93%) were no-cancer patients; 20,712 (50%) were administrated with NOACs and 20,742 (50%) were administrated with traditional anticoagulants. The use of NOACs had a superior NCB than traditional anticoagulation in both cancer patients (OR: 0.68, 95%CI: 0.50-0.85 for narrow NCB; OR: 0.76, 95%CI: 0.61–0.91 for broad NCB) and no-cancer patients (OR: 0.75, 95%CI: 0.54-0.96 for narrow NCB; OR: 0.85, 95%CI: 0.67–1.04 for broad NCB), with the estimates mainly from VTE patients receiving long-term warfarin treatment. In conclusion, NOACs may represent a better NCB property compared to traditional anticoagulants in cancer patients who need long-term anticoagulation treatment.
Highlights
Venous thromboembolism (VTE) is highly prevalent in patients with cancer, occurring up to 15% of cancer patients during the course of their diseases (Caine et al, 2002; Elalamy et al, 2017)
Studies were considered potentially eligible for this systematic review if they met the following predetermined criteria: (1) only randomized controlled trials (RCTs) that reported intested data of patients with or without cancer were included; and (2) VTE events, major bleeding events (MBEs), or clinically relevant bleeding events (CRBEs) were objectively assessed in non-vitamin K antagonist oral anticoagulants (NOACs) groups and traditional anticoagulation groups, respectively
The literature search yielded 4,228 records, of which 47 fulltext articles were obtained to further assess for eligibility, and 9 eligible RCTs were included in the final analyses (Schulman et al, 2009, 2014; Bauersachs et al, 2010; Goldhaber et al, 2011; Büller et al, 2012, 2013; Agnelli et al, 2013; Cohen et al, 2013; Raskob et al, 2018)
Summary
Venous thromboembolism (VTE) is highly prevalent in patients with cancer, occurring up to 15% of cancer patients during the course of their diseases (Caine et al, 2002; Elalamy et al, 2017). A prominent role is attributed to ability of tumor cells to destabilize the coagulation system including releasing procoagulant proteases, expressing tissue factor on cancer cells, deriving microvesicles, as well as altering the extracellular matrix of the cancer cell milieu (Nickel et al, 2016). These patients, when receiving anticoagulant treatment, have a high risk of recurrent VTE, while prossessing the danger of bleeding complications (Prandoni et al, 2002). LMWH is the recommended anticoagulant for the treatment of cancer-associated VTE
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