"The Stent Blog is a must-read resource"   -- ConcurringOpinions.com

What is
'The Voice
in the Ear'?


Who's Burt?

Archives

« send comment »

RSS Feed

March 7, 2007 -- 6:02am EST

And The Winner Is...
Word on the street is that the FDA is planning to announce labeling changes for drug-eluting stents later today, during the CRT 2007 meeting in Washington. These changes have been anticipated ever since the FDA held its panel on stent safety back on December 7-8 and many recommendations were heard.

This announcement has not been confirmed but, since I didn't get enough of the Oscars this year, I thought I'd take a shot at predicting the winners (from those nominated at the December panel).

For Best Picture: Extended Antiplatelet Therapy. Currently dual antiplatelet therapy (aspirin plus clopidogrel/Plavix or ticlopidine/Ticlid) extends for 3 months (Cypher) or 6 months (Taxus). I'll bet on a recommendation of 12 months for patients with low risk of bleeding complications. This change is clearly the front-runner, having previously been recommended by all major cardiology and surgical organizations in January's Joint Science Advisory (a.k.a. The Golden Globes).

Best Director will be, I think, a caution to prescribing physicians to consider a bare-metal stent in patients who, for economic, clinical or other reasons, have a high likelihood of non-compliance with antiplatelet therapy or who are going to be needing surgical procedures which will require cessation of antiplatelet therapy. This one has gotten the clear recommendation of several groups as well. The question is whether it will become part of the label.

Finally for Best Actor/Actress, I vote for the "off label" label -- some language that advises prescribing physicians that the results and benefits of DES that have been demonstrated in clinical trials may differ from those when the device is used "off label". This is a dark horse, because of the complicated concept of the label defining the off-label, but I'll go with it.

If the announcement is made, I'll be posting the results later.

« comment »        « back to top »