Wednesday, January 23, 2013

New ACEP tPA Clinical Policy


If you're still skeptical about the use of tPA in stroke patients – too bad.  If you're not on the bus, it would seem now you're under it.  ACEP has published their new Clinical Policy regarding tPA use in the most recent issue of Annals of Emergency Medicine.  tPA should be offered to folks in the 0-3 hour window who meet NINDS criteria as a Level A recommendation.  This is based on the following Class I evidence:
  • Two studies that are negative for benefit (ECASS, ATLANTIS)
  • The post-hoc analysis of ATLANTIS B with 61 patients,
  • NINDS
The Level B recommendation is that tPA be considered for use off-label in the 3-4.5 hour window, based on ECASS III.

If you'll travel backwards in time a couple days (by scrolling down), you'll see I did a quick review of two articles concerning the "trustworthiness" of clinical practice guidelines.  The Institute of Medicine names eight criteria – and, for the most part, this guideline does OK.  It does, unfortunately, fare less well at the conflict of interests declared:
  • Dr. Smith – Served on scientific advisory board for Genentech.
  • Dr. Gronseth – Speakers' bureau for, and honoraria from, Boehringer Ingelheim.
  • Dr. Messe – Former speakers' bureau for Boehringer Ingelheim.
Three out of eight guideline writers directly involved with the pharmaceutical manufacturer.   As far as indirect support, however, if they wanted to be more transparent, Dr. Edlow, Dr. Jagoda, Dr. Stead, Dr. Wears, and Dr. Decker also ought to have disclosed their association with the Foundation for Education and Research in Neurologic Emergencies – supported by multitudinous pharmaceutical manufacturers, including Genentech.

If you're irritated that pharmaceutical manufacturers are helping write our clinical guidelines, make your voice heard.

"Clinical Policy: Use of Intravenous tPA for the Management of Acute Ischemic Stroke in the Emergency Department"

6 comments:

  1. If you are very quiet....I bet you can almost hear Jerry Hoffman's head exploding:-)

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  2. And, if you listen to the EMA he recorded yesterday, you will literally get to hear his head explode.

    Contact your local chapter, the ACEP board, or write to Annals if you have feedback you'd like provide over the content or quality of this Clinical Policy.

    ReplyDelete
  3. Jerome Hoffman relayed this comment to add:

    "Excellent blog, Ryan. It's helped put my head back together! (It never actually exploded … much to the chagrin of some of the TPA zealots, I assume).

    Yes – we all need to let ACEP (and AAEM) know how we feel about their crazy change in policy."

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  4. Crazy change in policy? 17 years post NINDS and 3 years after AAEM took the ethical high road and recinded it's prior statement. This is an embarrassment frankly for ACEP. In hindsight, there were egos that were intent on burying their heads in the sand, swayed not by data that reinforced the benefits of tpa in spite of the risks, ignoring aha/asa guidelines for 10 years? A charismatic and very bright physician he is, but- related to TPA - he simply got it wrong. Why that is so hard to get a consensus around? It borders on funny almost. There's a degree of honor is admitting a wrong. Could there be a better example than this? In the face of data and science to stand his stubborn ground has isolated him for years and hurt the profession.

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  5. My personal favorite line in the policy is, "IST-3 looked at a different cohort of patients than those on which
    this policy focuses." A not so subtle way of saying, "Whatevs, we already had our minds made up."

    ReplyDelete

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