Bleeding in patients receiving non-vitamin K oral anticoagulants: clinical trial evidence

Abstract

In optimizing anticoagulation therapy, it is essential to balance treatment efficacy with the major adverse effect of anticoagulant treatment, bleeding risk. This narrative review examines the efficacy and safety of the non-vitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban compared with standard anticoagulation or placebo. NOAC therapies provide equivalent to superior protection versus standard therapy, with similar or superior safety, and potential benefits in convenience. We will review the phase III evidence for each of the available NOACs in different antithrombotic indications, including atrial fibrillation (in the absence of significant mitral stenosis or mechanical heart valves); prophylaxis of venous thromboembolism (VTE) in patients undergoing orthopedic surgery; and acute and long-term treatment of VTE. Further, we will illustrate scenarios in which the evidence is stronger for a particular agent in the context of the overall positive safety and efficacy profile of NOACs in general. Limitations of the factor Xa inhibitors include the lack of a specific antidote in case of a bleeding emergency (an approved agent is available for reversing the effect of the direct thrombin inhibitor). We discuss the options for mitigating bleeding and describe the ongoing developments towards specific reversal agents. In conclusion, the available data for efficacy and safety, together with reliable pharmacokinetics obviating the need for regular monitoring, indicate that NOACs may offer substantial benefits for patients with nonvalvular atrial fibrillation or VTE.

Impact of pharmacist-conducted anticoagulation patient education and telephone follow-up on transitions of care: a randomized controlled trial

“…The fact that we included patients on all oral anticoagulants and for different indications, and had a relatively small sample size may have limited the ability to discern any differences between the groups. In fact, VKAs and the different DOACs have shown different bleeding profiles in different patient populations [32][33][34]. It is worth noting that the majority of the bleeding events in our study were observed in patients prescribed DOACs within each arm (11 out of 14 in the pharmacist counseled arm and 10 out of 17 in the standard of care arm) but this study was not designed to compare the bleeding rates between VKA and DOACs.…”

Clasificación de los desenlaces en los ensayos clínicos

“…A continuación, se presenta una tabla con diferentes ejemplos de desenlaces de eficacia y seguridad, empleados en los ensayos clínicos aleatorizados. (Tabla 1) [9][10][11][12][13][14][15][16][17][18] .…”

Alt Ekstremite Venöz Tromboz Tedavisinde Yeni Oral Antikoagulanların Etkinliği: Retrospektif Klinik Çalışma

“…In recent years, new oral anticoagulant agents have been preferred in the treatment of serious diseases with high thrombosis risk (such as deep venous thrombosis, pulmonary embolism, atrial fibrillation), since they have less potential for side effects and do not require routine blood tests (1).Warfarin, a vitamin K antagonist,has been replaced by new oral anticoagulants in the standard treatment of deep venous thrombosis. Studies have shown that NOACs keeps the risk of major bleeding in a more reliable range (2). Similarly, significant reductions were seen in the risk of stroke and systemic embolism (3).…”