Abstract
ABSTRACT Background: Venous thromboembolism (VTE) is a common complication in cancer patients. We aim to evaluate the effect and safety of direct oral anticoagulants (DOACs) as primary prophylaxis in ambulatory cancer patients. Methods: We conducted a literature search in PubMed, EMBASE and ClinicalTrials for studies that evaluated DOACs for thromboprophylaxis in cancer patients. RevMan 5.3 software was used for this meta-analysis. Results: Three randomized controlled trials (RCTs) with a total of 1465 patients were pooled in the meta-analysis. DOACs significantly reduced the symptomatic VTE incidence during intervention period (RR 0.23, CI 0.11-0.47, P<0.0001, I2 =9%). Significantly lower total VTE incidence (RR 0.53, CI 0.36-0.78, P = 0.001, I2 =30%) and PE incidence (RR 0.50, CI 0.28-0.89, P = 0.02, I2 =5%) were found during the observation period, and a trend for less symptomatic DVT events was found in the DOACs group (RR 0.62, CI 0.37-1.04, P = 0.07, I2 =5%). No differences for all-cause mortality were found between groups (RR 0.92, CI 0.74-1.15, P = 0.47, I2 =14%). DOACs did not significantly increase major bleeding risks (RR 1.66, CI 0.72-3.83, P = 0.24, I2 =0%) during the intervention period or clinically relevant non-major bleeding events (RR 1.50, CI 0.90-2.49, P = 0.12, I2 =0%) and total bleeding events during the observation period (RR 1.50, CI 0.98-2.29, P = 0.06, I2 =0%). Conclusion: DOACs are effective for thromboprophylaxis in ambulatory cancer patients, but there is a potential risk of bleeding. DOACs may be recommended in selected patients at high risk of VTE. More high-quality studies are needed to further validate our results. Abbreviations: CAT: cancer-associated thrombosis; CI: confidence interval; DOAC: direct oral anticoagulant; DVT: deep vein thrombosis; LMWH: low molecular weight heparin; NNH: number needed to harm; NNT: number needed to treat; PE: pulmonary embolism; RCT: randomized controlled trials; RR: risk ratio; RD: rate difference; VTE: venous thromboembolism.
Highlights
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication that frequently occurs during the treatment and follow-up of cancer patients [1,2]
Three studies with a total of 1465 patients were pooled in the meta-analysis, including 740 patients receiving direct oral anticoagulant (DOAC) for thromboprophylaxis and 725 patients receiving placebo
The results of our study showed that using DOACs to prevent thrombosis may significantly reduce the incidence of VTE, PE and DVT without increasing the risk of major bleeding, clinically relevant non-major bleeding and total bleeding events
Summary
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication that frequently occurs during the treatment and follow-up of cancer patients [1,2]. Results: Three randomized controlled trials (RCTs) with a total of 1465 patients were pooled in the meta-analysis. Lower total VTE incidence (RR 0.53, CI 0.36-0.78, P = 0.001, I2=30%) and PE incidence (RR 0.50, CI 0.28-0.89, P = 0.02, I2=5%) were found during the observation period, and a trend for less symptomatic DVT events was found in the DOACs group (RR 0.62, CI 0.37-1.04, P = 0.07, I2=5%). DOACs did not significantly increase major bleeding risks (RR 1.66, CI 0.72-3.83, P = 0.24, I2=0%) during the intervention period or clinically relevant non-major bleeding events (RR 1.50, CI 0.90-2.49, P = 0.12, I2=0%) and total bleeding events during the observation period (RR 1.50, CI 0.98-2.29, P = 0.06, I2=0%). Conclusion: DOACs are effective for thromboprophylaxis in ambulatory cancer patients, but there is a potential risk of bleeding. More high-quality studies are needed to further validate our results
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