Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Abstract

Background Annually > 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated. Methods Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality. Results Of the 1442 patients, 280 (19%) were < 65, 550 (38%) were 65–74, 514 (36%) 75–84, and 98 (7%) were 85 years old or older. With increasing age, comorbidities and risk scores were higher. Any bleeding complications were uncommon across all ages, ranging from 3.9% in patients < 65 to 4.1% in those 85 years or older; major bleeding rates in any age group were ≤ 0.6%. Interruption rates and duration increased with advancing age. Thromboembolic events were more common in the elderly, with all nine events occurring in those > 65, and seven in patients aged > 75 years. Conclusion Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed. Trial registration: NCT# 02950168, October 31, 2016

Periinterventional Management of Edoxaban in Major Procedures: Results from the DRESDEN NOAC REGISTRY

“…Colonna et al 10 and Unverdorben et al 11 recently reported on the periprocedural management of edoxaban patients in the EMIT registries. Here, 123 of 280 cases (44%) undergoing high bleeding risk procedures had a preprocedural interruption <48 hours and 30 (11%) had an interruption longer than 72 hours.…”

“…Unfortunately, cardiovascular events and mortality were not reported separately for patients undergoing major procedures. 18 The observational EMIT registries 10,11 followed SPAF and VTE patients with edoxaban in routine clinical care in a multinational setting and evaluated efficacy and safety in more than 1,000 patients undergoing a wide range of different procedures, including 280 major procedures. Similar to PAUSE, the EMIT registries showed higher rates of bleeding events in major compared with minor procedures (5.7 vs. 3.1%), although only five major events bleeding were documented in total (0.4% of all 1,155 procedures).…”

“…7,9 However, data on management patterns and clinical outcomes following major surgical procedures in edoxaban patients are scarce, since edoxaban was the latest NOAC to be approved. Recently published data from the Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE) studies 10,11 provide some insights into this topic but less than 25% of the evaluated procedures were high-risk procedures according to the European Heart Rhythm Association (EHRA) classification 7 and complication rates in this subset of procedures were considerably higher than in the minor and low-risk categories.…”

Correction to: Elderly patients with atrial fibrillation in routine clinical practice: peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

“…After publication of the original article [ 1 ], the authors identified an error in Table 1 related to two values on EHRA bleeding risk-low row.…”

Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program

“…Among the most frequently performed procedures are those requiring arterial and/or vascular access, such as coronary angiographies, percutaneous coronary interventions, valvular procedures, and ablations. 10 , 14 , 15 No clear evidence exists for the optimal time to interrupt or reinstate oral anticoagulation, balancing the reduction of MB against the potential higher risk of ischemic events, notably, thromboembolic stroke. It is also unclear which criteria physicians use to determine their periprocedural oral anticoagulation strategy and whether they would decide to use other antithrombotic agents during that interruption.…”