Study hints at low bleeding, CV risk with periprocedural edoxaban

Patients on the anticoagulant drug edoxaban could safely continue their treatment while undergoing certain procedures, with a low incidence of bleeding and cardiovascular events reported in the prospective EMIT AF/VTE* study.

The rates of major bleeding and clinically relevant non-major bleeding (CRNMB) were low (1.1 percent), as were the rates of thrombotic or ischaemic events (0.6 percent), said Dr Paolo Colonna from the Policlinico of Bari Hospital, in Bari, Italy, who presented the findings at EHRA 2019.

The results are based on the first procedures conducted in 1,155 patients (mean age 71.9 years, 62.3 percent male). About a quarter of the patients were of either high or minor bleeding risk** (24 [n=280] and 26 percent [n=294], respectively). A majority of the patients (n=1,070) had atrial fibrillation. The most frequent procedures were vascular access and transcatheter diagnostic and interventions (37.6 percent) – mainly electrophysiologic interventions (n=153) – followed by cardiothoracic and vascular surgery procedures (11.8 percent) and dental procedures (11 percent).

Thirty percent of patients had uninterrupted (without skipping a single dose) edoxaban treatment during the periprocedural period. Sixty-eight percent of patients had ≥1 day pre-procedure interruption (median, 2 days), while 27 percent had ≥1 day post-procedure interruption (median, 3 days). Twenty-four percent of patients had both pre- and post-procedure interruptions (median, 5 days).

The incidence of major or CRNMB over 30 days following the procedure was low overall, with five and eight events, respectively. The five major bleeding incidents occurred in one patient with a minor risk of bleeding and two each with low and high risk of bleeding. Two of these major bleeding events were considered unrelated to edoxaban, with the last edoxaban dose taken 3 and 6 days, respectively, prior to bleeding incident. [EHRA 2019, abstract 1241]

CRNMB occurred in four patients with low risk and four with high risk of bleeding. Three CRNMB incidents were considered unrelated to edoxaban, with the last dose taken 4, 6, and 19 days, respectively, before the bleeding incident.

Thirty-six patients experienced minor bleeding, eight, 18, and 10 of whom were categorized as being at a minor, low, and high risk of bleeding, respectively.

The incidence of cardiovascular events over the 30-day period was also low with one incident each of stroke, transient ischaemic attack, systemic embolism, and acute coronary syndrome, two events of pulmonary embolism (with or without deep vein thrombosis), and two cardiovascular-related deaths.

“[The EMIT-AF VTE study] confirms the good safety profile of edoxaban overall and in high bleeding risk procedures,” said Colonna, who pointed out the current scarcity of information on the outcomes of periprocedural use of novel oral anticoagulants NOACs, especially, edoxaban.

“[This trial] fills an important gap in the evidence of peri-interventional NOAC management,” said study discussant Professor Jan Steffel from the University Hospital Zurich in Zurich, Switzerland.

There are certain patients, such as those with high bleeding risk, who may need to have their NOACs interrupted. However, for a large proportion of patients, procedures can be done without NOAC interruption, said Steffel, who suggested skipping the morning dose on the day of the procedure and restarting therapy either the same day or the next day. He also recommended against bridging therapy for NOACs.

In procedures that carry a high bleeding risk or where minor bleeding could have major complications such as in neurosurgery or heart surgery, NOACs can be stopped about 48 hours pre-procedure and restarted based on the patient’s risk of stroke, he said, calling for further research on NOAC management in high-risk procedures.