Endpoints
The subcommittee on control of anticoagulation of the Scientific and
Standardization committee of the International Society on Thrombosis and
Haemostasis [15] recommends that bleeding causing a fall in the
hemoglobin level of 2 g/dL or more meets the criteria for major
bleeding. Based on this recommendation, a fall in the hemoglobin level
from baseline of ≥2 g/dL 24 hours after the ablation was determined as
the primary endpoint, regardless of whether or not any overt bleeding
was seen. The secondary endpoints included major or minor bleeding
complications. Major bleeding complication was defined as the occurrence
of cardiac tamponade, hematoma requiring intervention, hemothorax, or
retroperitoneal bleeding. Minor bleeding complications were defined as
hematoma or any bleeding that did not require any intervention or a
prolonged hospital stay [16].