The number needed to treat to avoid a serious vascular event was 91 patients, with 112 being the number needed to cause a major bleeding event
. The risk of major bleeding rose with increasing baseline 5-year vascular event risk.
The REVERSE-AD study (reversal effects of idarucizumab on active dabigatran; Clinicaltrials.gov NCT02104947) studied 504 patients on dabigatran needing urgent reversal due to major bleeding event
or due to the need for emergent surgery or procedure.
In patients treated with apixaban and rivaroxaban from the Mayo Thrombophilia Registry, two patients out of 36 treated with NOACs (5.55%) with underlying malignancy had a major bleeding event
They found the risk for a major bleeding event
was 1.46 percent until age 70.
Among patients taking the anticoagulant drug warfarin (Coumadin), obese patients are at much higher risk than non-obese patients of a major bleeding event
, according to research presented in May 2015 at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology/ Peripheral Vascular Disease Scientific Sessions.
William Lis, Portola's chief executive officer, said "Andexanet alfa represents a potential important advance to the field of anticoagulation for Factor Xa inhibitor patients who suffer a major bleeding event
or those requiring emergency surgery.
It has been estimated that 10-16% of patients treated with warfarin will have a major bleeding event
A major bleeding event
was defined as clinically overt bleeding in association with a hemoglobin decrease of 2 g/dL or more, transfusion of two or more units of red blood cell concentrates or whole blood, bleeding in a critical location (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding.
Five (0A[cedilla]7%) of 769 patients in the nadroparin group and no patients in the placebo group had a major bleeding event
A physician had questioned the practice based on a major bleeding event
in one of his patients that he attributed to the quantity and strength of the locking dose.
During 2 years of prospective follow-up, 581 patients (7.8%) experienced a major bleeding event
as defined by International Society on Thrombosis and Haemostasis criteria.