Rivaroxaban does not increase the risk of fatal gastrointestinal bleeding

Evidence shows that in the past, Rivaroxaban in comparison with Warfarin increases the risk of atrial fibrillation in patients with gastrointestinal bleeding, which makes the safety of Rivaroxaban is being questioned, anticoagulation should choose Rivaroxaban in the process? Recently published in JACC, the latest ROCKET AF data show that Rivaroxaban-related gastrointestinal (GI) bleeding than Warfarin, but the two groups of patients with serious gastrointestinal bleeding was similar, and very few had fatal bleeding events. Reference Matthew w. Sherwood (Duke University Medical Center) 14236 cases such as ROCKET AF patients in the treatment group were analyzed, the primary endpoint was the first drug usage to 2 days after the end of gastrointestinal bleeding event during. Sherwood found a total of 684 cases occurred in patients with gastrointestinal bleeding. Compared with patients without gastrointestinal bleeding, gastrointestinal hemorrhage in patients with high age (75 years old vs. 73), and mostly male. 48% hemorrhage in the upper digestive tract, 23% in the lower gastrointestinal tract, 29% in the rectum, no differences between the treatment groups.

Curves of incidence of gastrointestinal bleeding-time

Curves of incidence of gastrointestinal bleeding-time

Rivaroxaban group and Warfarin group of major or non-major clinically relevant incidence of gastrointestinal bleeding was 3.61/100 person with 2.6/100 person (HR = 1.42;95% CI,1.22-1.66). Need more than 4 units of blood transfusion and serious gastrointestinal bleeding (Rivaroxaban0.47/100 person, Warfarin 0.41/100 person; HR = 1.19; 95% CI, 0.8-1.77) or fatal bleeding (Rivaroxaban 0.01/100 person, Warfarin 0.04/100 person; HR = 0.21; 95% CI, 0.02-1.76) no significant differences in the incidence. Study a total of 6 cases of fatal gastrointestinal bleeding, of which 5 occurred in the Warfarin group.

Two groups of digestive tract hemorrhage square map

Two groups of digestive tract hemorrhage square map

Researchers have found that the following independent Predictor of digestive tract hemorrhage: baseline anemia (HR = 1.7;95% CI,1.41-2.04), previous gastrointestinal bleeding (HR = 2.11;95% CI,1.62-2.76), the long-term use of aspirin (HR = 1.47;95% CI,1.26-1.72), senior citizens (aged 5 years, HR = 1.11;95% CI,1.06-1.17), low diastolic pressure (80 Following decreased 5 mmHg,HR mmHg = 1.1;95% CI,1.05-1.16), smoke or used to smoke (HR = 1.37;95% CI,1.16-1.62), existing or pre-existing sleep apnea (HR = 1.6;95% CI,1.22-2.1), the baseline Proton pump inhibitor (HR = 1.36;95% CI,1.12-1.65), creatinine clearance rate is lower (60 mL/min Each of the following 5 lower units, HR = 1.06;95% CI,1.01-1.12), chronic obstructive pulmonary disease (HR = 1.3;95% CI,1.05-1.61), male (HR = 1.21;95% CI,1.01-1.44) and baseline using non-aspirin anti-platelet drugs (HR = 1.5;95% CI,1.02-2.21).

Expert view

Gregory Y.H. Lip and Deidre a. Lane (Denmark Aalborg thrombosis Research Institute) in an editorial said, the researchers stressed the importance of minimizing the anticoagulation in patients with risk factors for gastrointestinal bleeding, which is very wise. In the study of ROCKET AF, North American patient (HR = 1.89; 95% CI, 1.45-2.45) of Rivaroxaban in patients with gastrointestinal bleeding than other areas (HR = 1.21; 95% CI, 1-1.47), perhaps because the Warfarin Group North American patient care than patients in other parts of the window, and Warfarin is closely related to hemorrhage and therapeutic window range, INR control can cause blood clots, death or bleeding occurs.

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