The aim of this study was to compare the management and prognosis of major bleeding in patients treated with dabigatran or
warfarin.
Two independent investigators reviewed bleeding reports from 1034
individuals with 1121 major bleeds enrolled in 5 phase III
trials comparing dabigatran with warfarin in
27 419 patients treated for 6 to 36 months. Patients with major bleeds
on dabigatran
(n=627 of 16 755) were older, had lower
creatinine clearance, and more frequently used aspirin or non-steroid
anti-inflammatory
agents than those on warfarin (n=407 of
10 002). The 30-day mortality after the first major bleed tended to be
lower in the
dabigatran group (9.1%) than in the warfarin
group (13.0%; pooled odds ratio, 0.68; 95% confidence interval,
0.46–1.01; P=0.057). After adjustment for sex, age, weight, renal function, and concomitant antithrombotic therapy, the pooled odds ratio
for 30-day mortality with dabigatran versus warfarin was 0.66 (95% confidence interval, 0.44–1.00; P=0.051). Major bleeds in dabigatran patients were more frequently treated with blood transfusions (423/696, 61%) than bleeds
in warfarin patients (175/425, 42%; P<0.001) but less frequently with plasma (dabigatran, 19.8%; warfarin, 30.2%; P<0.001).
Patients who experienced a bleed had shorter stays in the intensive
care unit if they had previously received dabigatran
(mean 1.6 nights) compared with those who had
received warfarin (mean 2.7 nights; P=0.01).
Full Article: Management and outcomes of Major Bleeding During Treatment with dabigatran or warfarin
Circulation.
2013;
128:
2325-2332
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