From theheart.org
by: retireonme
Long-Term Sentiment: Strong Buy 07/19/03 09:15 am
Msg: 1757 of 1775
Just for the boards information here is some information on SAT's. This is from the heart.org site.
Jul 9, 2003
"Dear Colleague" letter reviewing Cypher SAT risk sent to doctors; FDA reports 47 cases of SAT
Rockville, MD - As promised, Cordis/Johnson & Johnson has sent out what company spokespeople insist is not a "Dear Doctor" letter, informing healthcare professionals "of the rare but potential risk of thrombosis associated with the use of . . . the CypherTM sirolimus-eluting coronary stent."
As reported by heartwire, the letter was prompted in part by the news that two patients who received the stent had died at St Francis Heart Center in Roslyn, NY.
Dated July 7, 2003, the letter, addressed to "Dear Colleague," opens with: "Subacute Thrombosis in Association with CYPHERTM Coronary StentsWhat is Known?" The two-page letter then goes on to acknowledge that the company has received adverse-event reports of stent thrombosis occurring at the time of implantation or shortly thereafter, with some centers reporting multiple adverse events. These events, however, fall well within the subacute thrombosis (SAT) rate seen with bare metal stents, the company says.
A press statement released by the FDA confirms that the agency has received 47 Medical Device Reports of stent thrombosis during or following stent implantation. More than 50 000 US patients have received the stent, which received FDA approval April 24, 2003.
What to do, what to avoid
The Cordis/J&J letter cites a range of reasons that might explain the SATs. "Based on the reports so far, factors impacting the rate of thrombosis may include failure to achieve adequate stent apposition (due to underdeployment) or suboptimal use of antiplatelet medication." Unavailability of larger stents may have led physicians to attempt to overexpand an undersized stent.
"Overexpansion of stents beyond their intended diameter may negatively affect performance and is not advisable," the letter reads.
To avoid risk of SATs, physicians should ensure that they choose the appropriate stent size in appropriate patients and not use the stent to treat in-stent restenosis, acute MI, saphenous vein grafts, or bifurcated lesions, the letter notes. As well, physicians should ensure that all patients receive adequate loading and three-month antiplatelet therapy. The letter also reminds physicians that the Cypher stent is not approved for direct stenting: predilatation with an appropriate PTCA balloon is required, and proper deployment is key to minimizing SAT risk.
Cordis/J&J plan to launch its postmarketing registry of the Cypher stent this month, the letter states.
Related links
1. Cordis/J&J "Dear Colleague" letter: Subacute Thrombosis in Association with CYPHER™ Coronary StentsWhat is Known?
2. Two deaths and SAT rumors prompt Cordis/J&J to send "reminder" letter to doctors [Heartwire > News; Jun 27, 2003]
Shelley Wood
shelley@conceptis.com |
