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].