Data source
From July 2017 to July 2019, data from a single institution were
collected in an open, double arm, retroprospective manner. The final
database was constituted by pre-operative demographic variable,
intra-operative interventional data and post-operative measurements.
Only the patients who underwent cardiac surgery and discharged with oral
anticoagulant were rolled in the study; patients with preexisting
bleeding disorders were excluded. Pre-operative use of any oral
anticoagulant did not constitute an exclusion criteria. All major,
elective, cardiac surgical procedures were considered; patients who
underwent urgent or emergency operation were excluded from the study.
The VKA included exclusively warfarin. The NOACs used were dabigatran,
rivaroxaban and apixaban.
Reasons for antithrombotic treatment at discharge were atrial
fibrillation, deep venous thrombosis, atrial myxoma and left ventricular
thrombus.
A bleeding event was defined as evidence of pericardial effusion, with
or without need of surgical intervention. The incidence of pleural
effusion, cerebral and abdominal hemorrhagic events were recorded but
not reported as not primary outcomes of the present study.
All the ischemic or thromboembolic events were collected and reported.
As ischemic event it was considered the incidence of cerebrovascular
events, bowel ischemia, lower limb ischemia or myocardial infarction. A
thromboembolic event was defined as incidence of deep venous thrombosis,
pulmonary embolism, cerebral infarct or systemic venous thrombosis.
The primary end point was the incidence of immediate postoperative
bleeding, defined as pericardial effusion requiring intra-hospital
re-exploration. This term was used to define any pericardial drainage
performed before discharge; this was then differentiated as early, if
within the first 72 hours from surgery, or late, if after 72 hours.
The key secondary composite end point was the late re-admission for
pericardial effusion, with or without need of surgical drainage.