WHOM specifically is going to take the obvious next step and come up with a protocol that prevents hemorrhagic transformation? As is, this is useless, no protocol created. With NO LEADERSHIP IN STROKE nothing will occur. Another useless research prediction.
Risk of Hemorrhagic Transformation with Early Use of Direct Oral Anticoagulants after Acute Ischemic Stroke: A Pooled Analysis of Prospective Studies and Randomized Trials
Abstract
Introduction:
Precise risk of hemorrhagic transformation (HT) in acute ischemic
stroke (AIS) remains unknown, leading to delays in anticoagulation
initiation for secondary stroke prevention. We sought to assess the rate
of HT associated with direct oral anticoagulant (DOAC) initiation
within and beyond 48 hours post-AIS.
Methods:
A pooled analysis of DOAC initiation within 14 days of AIS or transient
ischemic attack (TIA) was conducted with 6 studies (4 prospective open
label treatment, blinded outcome studies and 2 randomized trials;
NCT02295826 and NCT02283294). The primary endpoint was incident
radiographic HT on follow-up imaging (day 7–30). Secondary endpoints
included symptomatic HT, new parenchymal hemorrhage, recurrent ischemic
events, extracranial hemorrhage, study-period mortality, and follow-up
modified Rankin Scale score. The results were reported as odds ratio
(OR) or hazard ratio (HR) with 95% confidence interval (CI).
Results:
We evaluated 509 patients; median infarct volume was 1.5 (0.1–7.8) ml,
and median National Institutes of Health Stroke Scale was 2 (0–3).
Incident radiographic HT was seen on follow-up scan in 34 (6.8%)
patients. DOAC initiation within 48 hours from index event was not
associated with incident HT (adjusted OR 0.67, [0.30 – 1.50] P=0.32). No
patients developed symptomatic HT. Conversely, 31 (6.1%) patients
developed recurrent ischemic events, 64% of which occurred within 14
days. Initiating a DOAC within 48 hours of onset was associated with
similar recurrent ischemic event rates compared to those in which
treatment was delayed (HR 0.42, [0.17 – 1.008] P=0.052). In contrast to
HT, recurrent ischemic events were associated with poor functional
outcomes (OR=6.8, [2.84 – 16.24], p<0.001).
Conclusions:
In this pooled analysis, initiation of DOAC within 48 hours post-stroke
was not associated with increased incident risk of HT, and none
developed symptomatic HT. The analysis was underpowered to determine the
effect of early DOAC use upon recurrent ischemic events.
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