Table III.

Bleeding Events by Treatment Group (Heparin vs Bivalirudin) Primary Endpoint: Index up to 30 days post-procedure

	Patients in Heparin Group (n = 123)	Patients in Bivalirudin Group (n= 137)	p-value
All bleeding (Primary Endpoint)±	9 (7.3%)	15 (10.9%)	0.312
Major Bleeding*	3 (2.4%)	8 (5.8%)	0.174
Minor Bleeding¥	8 (6.5%)	12 (8.8%)	0.496
Retroperitoneal bleed	0 (0.0%)	1 (0.73%)	0.513
Gastrointestinal bleed	2 (1.63%)	5 (3.65%)	0.447
Intracranial bleed	0 (0.0%)	1 (0.73%)	0.513
Tamponade	0 (0.0%)	0 (0.0%)	-
Hemoptysis	0 (0.0%)	1 (0.73%)	0.513
Epistaxis	1 (0.81%)	3 (2.19%)	0.576
Hematuria unassociated with impact/trauma	0 (0.0%)	1 (0.73%)	0.513
Hematoma of ≥ 5 cm in Diameter	1 (0.8%)	2 (1.5%)	0.918
Surgical or endoscopic management of bleed	0 (0.0%)	0 (0.0%)	-
Transfusion of blood	1 (0.81%)	0 (0.0%)	0.375
Other bleeding	6 (4.88%)	5 (3.65%)	0.113

^±All bleeding was counted as a single composite event per patient regardless if they had different forms of bleeding

^*Major bleeding is defined as: intracranial, intraocular, or retroperitoneal hemorrhage, clinically overt blood loss resulting in a decrease in Hg of more than 3 g/dL, any decrease in Hg of more than 4 g/dL, or transfusion of 2 or more units of packed red blood cells or whole blood.

^¥Minor bleeding is defined as: clinically overt bleeding that did not meet criteria for major bleeding (i.e., all other).