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  • myxomatousdegeneration myxomatousdegeneration Jul 23, 1999 10:53 PM Flag

    Best Boston Interventional Cardioligist

    First of all it was I who posted the "5 points"
    of contention re: the SOPHOS trial not beezerx2 so
    you may direct your anger towards me not
    him.

    Secondly, and most importantly, it matters not a whit what
    you or I pontificate about on this board -- the
    randomized trial against the Duet will tell all. IF this
    stent can clearly lower restenosis rates by a
    clinically significant degree c/w the Duet then I would
    certainly tip my hat off to you and BC. I would hasten to
    add however that at this point in time you simply do
    not have adequate data to make any valid conclusions
    - the randomized trial, assuming it is adequately
    powered as I am sure it is, will answer that question
    once and for all. I would think that to prove
    superiority of one stent over another that VERY large numbers
    of patients would need to be enrolled. It is one
    thing to power a trial to prove equivalency (such as
    the various trials which went head to head against
    JNJ's P-S stent) but quite another to prove
    superiority. I would be interested to know what the enrollment
    numbers are like.

    Re: other trials and the % of
    patients enrolled with vessels < 3.0mm. In the combined
    STRESS I and STRESS II trials over 50% of the lesions
    treated were less than 3.0 mm. This came about because
    the trials were performed with visual analysis as the
    guide to whether a reference vessel was equal to or
    greater than 3.0 mm but when the films were sent to a
    core lab for quantitative analysis (after the stents
    were placed) it was found (not surprisingly) that
    eyeballing lesions is not an exact science and that
    investigators very frequently thought the vessels they were
    treating were larger than they truly were. The point is of
    course that many other trials have included large
    numbers of small vessels - not just the SOPHOS trial.
    Finally, the STRESS trials had 84% angiographic F/U and
    Benestent had 94% angiographic F/U. As you can see SOPHOS's
    F/U rate is poor and introduces a bias.

    I am
    tired of going back and forth about this as I am sure
    other BSX board members are. Indeed, one must wonder if
    this is the BSX board any longer instead of a BC
    board. We can piss and shout back and forth all we want
    -- lets simply wait for the randomized trial
    results. If BC "wins" then my hat will be off to you, but
    until then I remain the largest of skeptics....
    Do
    not feel the need to pull another "all nighter" in
    composing a reply... rather lets simply revisit this issue
    after the AHA.
    Have a NewCastle Brown Ale on me.

 
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