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Serious bleeding was numerically higher in ENHANCE than in PROWESS.
No serious bleeding was detected clinically or by CT scans in either group.
In a meta-analysis of 10,679 APC-treated patients, the incidence of serious bleeding was 3.3% [ 6].
However, rFVIIa can be taken into consideration as an additional therapeutic option if serious bleeding was refractory to conventional treatment.
However, the incidence of serious bleeding was higher in the DrotAA group than in the placebo group (3.5% versus 2.0%; P = 0.06).
A higher postinfusion rate of serious bleeding was observed in ENHANCE, suggesting a higher overall background bleeding rate, relative to PROWESS.
Similar(51)
Lower risk of infection and lower risk of serious bleeding were also of high importance to patients (each noted by 90.0% of patients).
Both mortality rate and the incidence of serious bleeding were significantly greater than in PROWESS.
Serious bleeding is the most feared adverse effect of vitamin K antagonists (VKA) such as warfarin.
The authors also report no difference in bleeding complications, yet serious bleeding is actually a relatively infrequent event in patients treated with APC.
There were no statistically significant differences in 28-day or hospital mortality between groups, but rates of serious bleeding were greater in the DrotAA group both during the infusion (2.4% vs. 1.2%, P = 0.02) and in the 28-day study period (3.9% vs. 2.2%, P = 0.01) and were similar to rates seen in the PROWESS trial.
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