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Comparative Effects Between Direct Oral Anticoagulants for Acute Venous Thromboembolism: Indirect Comparison From Randomized Controlled Trials.

ABSTRACT: Background: There is no direct comparison from clinical trials amongst the direct oral anticoagulants (DOACs) in patients with acute venous thromboembolism (VTE), leaving an evidence gap in decision-making regarding the choice of a DOAC. Methods: We performed a systematic review for an indirect comparison from randomized controlled trials (RCTs) for comparative effects amongst DOACs in the patients with acute VTE. Results: A total of 16 RCTs were included for analyses, among which three for dabigatran (n = 7,963 patients), six rivaroxaban (n = 17,935), five apixaban (n = 12,823), and two edoxaban (n = 9,286). There was no significant difference in risk of recurrent VTE (evidence quality: low) and major bleeding (evidence quality: very low) for treatment effects between the four DOACs. Albeit non-significantly, apixaban seemed to have a lowest risk of major bleeding while rivaroxaban had a smallest risk of VTE. Although in general all the included trials were comparable, data from the included trials indicated that the assumption of transitivity may be challenged. Further methodological research including simulation studies, using a net-benefit or benefit-harm approach, running ranking probability analysis, and developing decision aids with machine-learning may be a worthwhile endeavor to help with the choice of DOACs in patients with acute VTE. Conclusions: To conclude, based on results from the indirect comparison no significant difference in the efficacy and safety was found among the DOACs in patients with acute VTE. More evidence from direct comparative trials is needed to further inform the choice of DOACs in patients with acute VTE.

SUBMITTER: Li G

PROVIDER: S-EPMC7316891 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Comparative Effects Between Direct Oral Anticoagulants for Acute Venous Thromboembolism: Indirect Comparison From Randomized Controlled Trials.

Li Guowei G Zeng Jie J Zhang Junguo J Thabane Lehana L

Frontiers in medicine 20200619

Background: There is no direct comparison from clinical trials amongst the direct oral anticoagulants (DOACs) in patients with acute venous thromboembolism (VTE), leaving an evidence gap in decision-making regarding the choice of a DOAC. Methods: We performed a systematic review for an indirect comparison from randomized controlled trials (RCTs) for comparative effects amongst DOACs in the patients with acute VTE. Results: A total of 16 RCTs were included for analyses, among ...[more]

PMID: 32637418

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Project description:ObjectiveTo critically review the effectiveness of the novel oral anticoagulants (rivaroxaban, dabigatran, ximelagatran, and apixaban) in the treatment of acute venous thromboembolism.DesignSystematic review and random effects meta-analysis. Data were extracted independently by two investigators. An adjusted indirect comparison was performed to compare between novel oral anticoagulants.Data sourcesMedline, Embase, and Cochrane Library (from inception to April 2012). Hand searching of relevant scientific works and contact with experts.Study selectionRandomised controlled trials of novel oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism. Selected outcomes were recurrent events, major bleeding, and all cause mortality.ResultsNine studies met our inclusion criteria, involving 16,701 patients evaluated for efficacy and 16,611 for safety. Data were stratified according to different novel oral anticoagulants. For recurrent acute venous thromboembolism, there were no significant differences in events rates between any of the anticoagulants and conventional treatment (rivaroxaban (four studies): relative risk 0.85, 95% confidence interval 0.55 to 1.31; dabigatran (two studies): 1.09, 0.76 to 1.57; ximelagatran (two studies): 1.06, 0.62 to 1.80; and apixaban (one study): 0.98, 0.20 to 4.79). Rivaroxaban reduced the risk of major bleeding compared with conventional treatment (0.57, 0.39 to 0.84), whereas other novel oral anticoagulants did not (0.76 (0.49 to 1.18) for dabigatran; 0.54 (0.28 to 1.03) for ximelagatran; 2.95 (0.12 to 71.82) for apixaban). For all cause mortality there were no significant differences between the novel oral anticoagulants and conventional treatment (0.96 (0.72 to 1.27) for rivaroxaban; 1.00 (0.67 to 1.50) for dabigatran; 0.67 (0.42 to 1.08) for ximelagatran; 6.89 (0.36 to 132.06) for apixaban). The adjusted indirect comparison between rivaroxaban and dabigatran did not show superiority of either drug over the others for major bleeding (0.75, 0.41 to 1.34) or the other endpoints.ConclusionsCompared with vitamin K antagonists, the novel oral anticoagulants had a similar risk of recurrence of acute venous thromboembolism and all cause mortality, though rivaroxaban was associated with a reduced risk of bleeding.

Project description:Background: Direct oral anticoagulants (DOACs) are increasingly prescribed for the treatment of venous thromboembolism (VTE). However, little is known regarding pharmacists' practice patterns and preferences in clinical areas of contention, such as initiation dosing, obesity, and renal impairment. Objective: To determine pharmacist trends in practice regarding DOACs for the treatment of VTE overall and within areas of clinical controversy. Methods: An electronic survey was distributed to pharmacists in the United States through national and state pharmacy organizations. Responses were collected for 30 days. Results: One hundred fifty-three complete responses were submitted. The majority of pharmacists preferred apixaban (90.2%) for the oral treatment of venous thromboembolism. When initiating apixaban or rivaroxaban for a new VTE, 76% and 64% of pharmacists surveyed, respectively, state the duration of the initiation dose phases are reduced if the patient received parenteral anticoagulation. Fifty-eight percent of pharmacists used body mass index to evaluate the appropriateness of DOACs in obese patients whereas 42% used total body weight. Preference for rivaroxaban (31.4%) was higher in this population compared to the global population (10%). Apixaban was preferred for patients with renal impairment (92.2%). However, as creatinine clearance as calculated by the Cockcroft-Gault equation (CrCl) reduced to ≤15 milliliters/minute (mL/min), preference for warfarin increased (36%). Conclusion: This national survey of pharmacists demonstrated an overall preference for apixaban and significant variability in practice patterns regarding DOACs for patients with new VTE, patients with obesity, and patients with renal impairment. Further research is warranted to evaluate the efficacy and safety of DOAC initiation dosing phase modifications. Prospective evaluations of DOACs in obese and renal dysfunction populations would confirm the safety and efficacy of DOACs in these populations.

Project description:Anticoagulation for cancer-associated venous thromboembolism (VTE) can be challenging due to complications-including bleeding and potential drug-drug interactions with chemotherapy-associated with vitamin K antagonists and inconvenience of low-molecular-weight heparin (LMWH). Direct oral anticoagulants (DOACs) could partially overcome these issues, but until recently there were no large clinical trials assessing their efficacy and safety in cancer patients. This review summarizes clinical treatment guidelines, prior clinical and real-world evidence for anticoagulant choice, recent clinical trials assessing DOACs for cancer-associated VTE (i.e. Hokusai-VTE Cancer, SELECT-D, CARAVAGGIO, and ADAM VTE), and special considerations for DOAC use. Based on established data, clinical guidelines recommend patients with cancer-associated VTE receive LMWH treatment of at least 3-6 months. Nevertheless, LMWH is underused and associated with poor compliance and persistence in these patients relative to oral anticoagulants. Clinical data supporting DOAC use in cancer patients are becoming available. In Hokusai-VTE Cancer, edoxaban was noninferior to dalteparin for the composite of recurrent VTE and major bleeding (12.8% versus 13.5%), with numerically lower recurrent VTE (7.9% versus 11.3%) and significantly higher major bleeding (6.9% versus 4.0%); only patients with gastrointestinal cancer had significantly higher risk of bleeding with edoxaban. In SELECT-D, rivaroxaban had numerically lower VTE recurrence (4% versus 11%), comparable major bleeding (6% versus 4%), and numerically higher clinically relevant nonmajor bleeding (13% versus 4%) versus dalteparin. Most bleeding events were gastrointestinal or urologic; patients with esophageal/gastroesophageal cancer had higher rates of major bleeding with rivaroxaban (36% versus 11%). For comparison of apixaban versus dalteparin, CARAVAGGIO is ongoing, and preliminary results from ADAM VTE are favorable. This review concludes that DOACs appear to be reasonable alternatives to LMWH for treatment of cancer-associated VTE. In patients with gastrointestinal cancer, DOAC use should be considered on a case-by-case basis with consideration of the relative risks and benefits.

Dataset Information

Comparative Effects Between Direct Oral Anticoagulants for Acute Venous Thromboembolism: Indirect Comparison From Randomized Controlled Trials.

Publications

Comparative Effects Between Direct Oral Anticoagulants for Acute Venous Thromboembolism: Indirect Comparison From Randomized Controlled Trials.

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