The potential of target-specific oral anticoagulants for the acute and long-term treatment of venous thromboembolism

Abstract

Background:

Venous thromboembolism (VTE) comprises both deep vein thrombosis and pulmonary embolism. VTE is a leading cause of morbidity and mortality worldwide and its increasing incidence and prevalence are a major health concern. The primary medical objective during the acute phase of VTE treatment is to prevent thrombus extension and embolization. Extended treatment aims to prevent or minimize long-term complications, such as recurrent VTE, post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension.

Scope:

Anticoagulant therapy has been the mainstay of treatment for VTE and traditionally involves initial therapy with heparin, overlapping with and followed by a vitamin K antagonist. Although effective, standard heparin/vitamin K antagonist therapy has several limitations that can be overcome by more recently developed target-specific oral anticoagulants (TSOACs). These agents have predictable pharmacokinetics, a rapid onset of action and few drug–drug or drug–food interactions. Furthermore, TSOACs offer convenient anticoagulation without the need for routine coagulation monitoring and dose adjustment.

Findings:

The efficacy and safety data from phase III clinical trials support the use of TSOACs for VTE treatment, including in special patient populations. Risk-stratification tools and strategies have been developed to assist physicians in managing anticoagulation treatment.

Conclusions:

Rivaroxaban is the first TSOAC to gain widespread approval for the treatment of acute deep vein thrombosis and pulmonary embolism and the long-term prevention of recurrent VTE as monotherapy. Dabigatran has also been approved for this indication recently. TSOACs, especially as monotherapy, represent a paradigm shift in clinical practice for the management of patients with VTE.

Keywords::

• Anticoagulants
• Bleeding
• Clinical trial
• Phase III
• Risk assessment
• Venous thromboembolism/complications

Transparency

Declaration of funding

Editorial support was provided with funding from Bayer HealthCare Pharmaceuticals and Janssen Scientific Affairs LLC.

Declaration of financial/other relationships

F.A. has disclosed that he has received sponsorship from Bayer HealthCare Pharmaceuticals and Janssen Scientific Affairs LLC. A.C.S. has disclosed that he has received consulting fees from Astellas, Boehringer Ingelheim, Bristol-Myers Squibb, and Johnson & Johnson.

CMRO peer reviewer 1 has disclosed that she has received grants from Bayer, Boehringer Ingleheim, BMS, and Daiichi Sankyo. Peer reviewer 2 has no relevant financial or other relationships to disclose.

Acknowledgments

The authors would like to acknowledge Jasmina Saric, who provided editorial support.