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Abstract
<p class="first" id="d6928466e111">Background and Purpose- Deep vein thrombosis (DVTs)
is a common disease with high
morbidity if it progresses to pulmonary embolus (PE). Anticoagulation is the treatment
of choice; warfarin has long been the standard of care. Early experience with direct
oral anticoagulants (DOACs) suggests that these agents may be may be a safer and equally
effective alternative in the treatment of DVT/PE. Nontraumatic intracranial hemorrhage
(ICH) is one of the most devastating potential complications of anticoagulation therapy.
We sought to compare the rates of ICH in patients treated with DOACs versus those
treated with warfarin for DVT/PE. Methods- The MarketScan Commercial Claims and Medicare
Supplemental databases were used. Adult DVT/PE patients without known atrial fibrillation
and with prescriptions for either a DOAC or warfarin were followed for the occurrence
of inpatient admission for ICH. Coarsened exact matching was used to balance the treatment
cohorts. Cox proportional-hazards regressions and Kaplan-Meier survival curves were
used to estimate the association between DOACs and the risk of ICH compared with warfarin.
Results- The combined cohort of 218 620 patients had a median follow-up of 3.0 months,
mean age of 55.4 years, and was 52.1% women. The DOAC cohort had 26 980 patients and
8 ICH events (1.0 cases per 1000 person-years), and the warfarin cohort had 191 640
patients and 324 ICH events (3.3 cases per 1000 person-years; P<0.0001). The DOAC
cohort had a lower hazard ratio for ICH compared with warfarin in both the unmatched
(hazard ratio=0.26; P=0.0002) and matched (hazard ratio=0.20; P=0.0001) Cox proportional-hazards
regressions. Conclusions- DOACs show superior safety to warfarin in terms of risk
of ICH in patients with DVT/PE.
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