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Treatment Effect of Rivaroxaban in the Extended Treatment of Venous Thromboembolism: A Comparative Network Meta-Analysis
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A6346 - Treatment Effect of Rivaroxaban in the Extended Treatment of Venous Thromboembolism: A Comparative Network Meta-Analysis
Author Block: V. Mai1, S. Provencher1, M. Cucherat2, S. Jardel2, L. Bertoletti3, J. Lega2; 1Institut universitaire de cardiologie et de pneumologie de Québec Research Center, Laval University, Quebec City, QC, Canada, 2Laboratoire de Biométrie et Biologie Évolutive, CNRS, Université Claude-Bernard Lyon 1, Lyon, France, 3Service de Médecine Vasculaire et Thérapeutique, CHU de Saint-Etienne, Saint-Etienne, France.
Background: Extended treatment is required in a significant proportion of patients with unprovoked venous thromboembolism (VTE). The EINSTEIN-CHOICE trial reported the treatment effect of rivaroxaban at 10 mg and 20 mg doses compared to low dose aspirin in secondary VTE prevention. However, comparisons of low-dose rivaroxaban to other anticoagulants are lacking.
Objective: To compare the efficacy and safety of rivaroxaban to vitamin K antagonist (VKA), other direct oral anticoagulants (DOA) and antiplatelet drugs in the secondary prevention of VTE.
Methods: A systematic literature search (Pubmed, Embase, through May 31st 2017) was conducted to identify randomized controlled trials studying different pharmacologic therapies in the secondary prevention of VTE. The rates of symptomatic recurrent VTE (primary efficacy outcome), major bleeding (MB, primary safety outcome) and death were extracted. Treatment effects were calculated using network meta-analysis with frequentist random-effects methods.
Results: 17 randomized controlled trials met the inclusion criteria, which included 18221 patients. All the studied treatments (rivaroxaban, apixaban, dabigatran, ximelagatran, low intensity and standard adjusted dose VKA, sulodexide, idraparinux) reduced the rate of recurrent VTE compared to placebo, except for aspirin (RR 0.60; 95%CI 0.29-1.24). Compared to patients receiving rivaroxaban, other treatments were associated with a similar rate of recurrent VTE except for aspirin (RR 3.03; 95%CI 1.43-6.42 and RR 3.01; 95%CI 1.90-4.78, when compared to rivaroxaban 10 mg and 20 mg once daily, respectively). Apixaban 2.5/5mg was associated with fewer MB compared to rivaroxaban (RR 0.03; 95%CI 0.00-0.55 and RR 0.06; 95%CI 0.00-0.76, respectively). Compared to rivaroxaban 10/20 mg, the other drugs were not associated with a difference for the MB risk. The net clinical benefit combining VTE recurrence and MB was similar amongst all drugs except for aspirin (RR 3.01; 95%CI 2.96-8.16). Apixaban 2.5 and 5 mg, rivaroxaban 10 mg, and dabigatran 150 mg were associated with the highest probability to be the best therapy (82%, 79%, 77%, and 73%, respectively). Overall, the risk of death was comparable for all drugs.
Conclusion: VKA and DOA, including rivaroxaban 10 and 20 mg daily, had similar effects on VTE recurrence, whereas aspirin was associated with the lowest risk reduction. Conversely, apixaban was associated with a lower risk of MB compared to rivaroxaban. Nevertheless, net clinical benefit and death may be similar among all anticoagulants. In regards of the limits of indirect comparisons, these results have to be view as exploratory.
Author Block: V. Mai1, S. Provencher1, M. Cucherat2, S. Jardel2, L. Bertoletti3, J. Lega2; 1Institut universitaire de cardiologie et de pneumologie de Québec Research Center, Laval University, Quebec City, QC, Canada, 2Laboratoire de Biométrie et Biologie Évolutive, CNRS, Université Claude-Bernard Lyon 1, Lyon, France, 3Service de Médecine Vasculaire et Thérapeutique, CHU de Saint-Etienne, Saint-Etienne, France.
Background: Extended treatment is required in a significant proportion of patients with unprovoked venous thromboembolism (VTE). The EINSTEIN-CHOICE trial reported the treatment effect of rivaroxaban at 10 mg and 20 mg doses compared to low dose aspirin in secondary VTE prevention. However, comparisons of low-dose rivaroxaban to other anticoagulants are lacking.
Objective: To compare the efficacy and safety of rivaroxaban to vitamin K antagonist (VKA), other direct oral anticoagulants (DOA) and antiplatelet drugs in the secondary prevention of VTE.
Methods: A systematic literature search (Pubmed, Embase, through May 31st 2017) was conducted to identify randomized controlled trials studying different pharmacologic therapies in the secondary prevention of VTE. The rates of symptomatic recurrent VTE (primary efficacy outcome), major bleeding (MB, primary safety outcome) and death were extracted. Treatment effects were calculated using network meta-analysis with frequentist random-effects methods.
Results: 17 randomized controlled trials met the inclusion criteria, which included 18221 patients. All the studied treatments (rivaroxaban, apixaban, dabigatran, ximelagatran, low intensity and standard adjusted dose VKA, sulodexide, idraparinux) reduced the rate of recurrent VTE compared to placebo, except for aspirin (RR 0.60; 95%CI 0.29-1.24). Compared to patients receiving rivaroxaban, other treatments were associated with a similar rate of recurrent VTE except for aspirin (RR 3.03; 95%CI 1.43-6.42 and RR 3.01; 95%CI 1.90-4.78, when compared to rivaroxaban 10 mg and 20 mg once daily, respectively). Apixaban 2.5/5mg was associated with fewer MB compared to rivaroxaban (RR 0.03; 95%CI 0.00-0.55 and RR 0.06; 95%CI 0.00-0.76, respectively). Compared to rivaroxaban 10/20 mg, the other drugs were not associated with a difference for the MB risk. The net clinical benefit combining VTE recurrence and MB was similar amongst all drugs except for aspirin (RR 3.01; 95%CI 2.96-8.16). Apixaban 2.5 and 5 mg, rivaroxaban 10 mg, and dabigatran 150 mg were associated with the highest probability to be the best therapy (82%, 79%, 77%, and 73%, respectively). Overall, the risk of death was comparable for all drugs.
Conclusion: VKA and DOA, including rivaroxaban 10 and 20 mg daily, had similar effects on VTE recurrence, whereas aspirin was associated with the lowest risk reduction. Conversely, apixaban was associated with a lower risk of MB compared to rivaroxaban. Nevertheless, net clinical benefit and death may be similar among all anticoagulants. In regards of the limits of indirect comparisons, these results have to be view as exploratory.
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