ANMCO Position Paper: the use of non-vitamin K dependent new oral anticoagulant(s) in pulmonary embolism therapy and prevention

Abstract

The new oral anticoagulants (NOACs) have radically changed the approach to the treatment and prevention of thromboembolic pulmonary embolism. The authors of this position paper face, in succession, issues concerning NOACs, including (i) their mechanism of action, pharmacodynamics, and pharmacokinetics; (ii) the use in the acute phase with the ‘double drug single dose’ approach or with ‘single drug double dose’; (iii) the use in the extended phase with demonstrated efficacy and with low incidence of bleeding events; (iv) the encouraging use of NOACs in particular subgroups of patients such as those with cancer, the ones under- or overweight, with renal insufficiency (creatinine clearance > 30 mL/min), the elderly (>75 years); (v) they propose a possible laboratory clinical pathway for follow-up; and (vi) carry out an examination on the main drug interactions, their potential bleeding risk, and the way to deal with some bleeding complications. The authors conclude that the use of NOACs both in the acute phase and in the extended phase is equally effective to conventional therapy and associated with fewer major bleeding events, which make their use in patients at higher risk of recurrences safer.

Acute pulmonary embolism: a concise review of diagnosis and management

“…Rivaroxaban and apixaban have a significantly lower bleeding risk when compared to VKA but currently have no direct reversal agent. 5,18,90,91 Current recommendations for anti-coagulation duration are separated by cause of VTE, such as (i) provoked by a transient risk factor (i.e. long haul flight or oral contraceptive pill); (ii) provoked by surgery; (iii) permanent risk factor (i.e.…”

“…93 Durations of treatment are summarised in Table 3. [13][14][15]90,91,[94][95][96][97][98][99] Indefinite, not necessarily meaning life-long, anticoagulation with rivaroxaban or apixaban significantly lowers recurrence rate with no increase in bleeding risk when compared to aspirin and placebo respectively. Though DOAC are superior to aspirin in recurrence prevention, indefinite aspirin is recommended in cases where DOAC are unsuitable.…”

“…However, the trials showing non‐inferiority of DOAC to VKA have altered management guidelines in Australia, where rivaroxaban and apixaban are now listed on the Pharmaceutical Benefits Scheme. Rivaroxaban and apixaban have a significantly lower bleeding risk when compared to VKA but currently have no direct reversal agent …”

“…Furthermore, thrombophilia testing is not recommended when VTE is precipitated by a major transient risk factor . Durations of treatment are summarised in Table . Indefinite, not necessarily meaning life‐long, anticoagulation with rivaroxaban or apixaban significantly lowers recurrence rate with no increase in bleeding risk when compared to aspirin and placebo respectively.…”

Evaluation of Rivaroxaban- and Dabigatran-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database (FAERS)

“…Non-vitamin K antagonist oral anticoagulants (NOACs) are increasingly considered as the preferred anticoagulation treatment to prevent stroke for patients with nonvalvular atrial brillation (NVAF) and to prevent and treat deep vein thrombosis (DVT) and pulmonary embolism (PE), particularly for anticoagulant-naive patients [1][2][3]. NOACs have a better risk-bene t pro le than vitamin K antagonists (VKAs) for management of NVAF and are better than low-molecular-weight heparin (LMWH) for treatment and prevention of DVT and PE [4,5].…”