The PHANTOM-S trial was conducted in Berlin, Germany and
published in JAMA. It was designed to study the use of ambulance based
thrombolysis (within 4.5 hours) for stroke as compared to conventional hospital
based thrombolysis. The primary outcome
was alarm-to-thrombolysis time. (This is obviously not a patient oriented
outcome.) Secondary outcomes included overall thrombolysis rate, ICH rate after
treatment, and 7 day mortality. Despite the title reporting to be a “randomized”
trial it most certainly wasn’t. Not to be pedantic but the JAMA reviewers
should know better.
The consent process is interesting to imagine. Think of the
conversation and information provided by a neurologist who arrives on your
doorstep with a mobile CT scanner and ready with tPA? In addition, they assumed
consent in patients unable to communicate. Implied consent is fine if the
therapy is of reasonable proven benefit without significant chance of harm. Many
would argue that tPA for stroke does not fit this mould.
Results? It is
absolutely no surprise that they were able to thrombolyse strokes quicker when it
was done in the back of a million dollar ambulance. The mean alarm to treatment
time was shortened by 25 minutes as
compared to hospital based thrombolysis.
A close look at the data shows that this special ambulance
with a stroke team was generally busy. On average they were dispatched 6 times
in a (16 hour) day. Thrombolysis was performed in an amazing one third of
strokes or about every other day. But
in the quest for fast and faster treatment it is certain that they must have
been treating a good number of stroke
mimics.
The big question one must ask is what happens to the vast
majority of patients who get thrombolysis of stroke? Answer... absolutely
nothing. No harm or benefit. If we consider a reasonable number needed to
treat of 8 (this number is clearly arguable one way or another) then this fancy
ambulance with mobile stroke team perhaps helped one patient about every two
weeks. How many of these were actually helped by getting it 25 minutes faster?
Regardless if you believe in the efficacy of stroke thrombolysis, it is absolutely clear that this is not an
effective use of resources.
Covering:
Ebinger M, Winger B, Wendt M, et al. Effect of the Use of Ambulance-Based Thrombolysis on Time to
Thrombolysis in Acute Ischemic Stroke. A Randomized Clinical Trial. JAMA
2014;311(16):1622-1631.
http://www.ncbi.nlm.nih.gov/pubmed/24756512
No comments:
Post a Comment