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In June 2006 in a column headlined “The Future of Drug-Coated Stents: A Big Issue or a Non-Issue?,” I
wrote:
"For something (the drug-eluting stent market) that grew from zero to $5.3 billion in three years flat, equally
dramatic changes are certainly not out of the question. I’ll be sure to keep you posted.”
In the reader poll accompanying that article, about 52 percent of you believed that “safety with drug-eluting
stents will become big in the next few months”. For those of you among the 52 percent, you are indeed right.
True to my word, I am here to update you with new developments and make some additional prognoses on
the drug-eluting stent (DES) market.
The DES Problem
To summarize, the “DES problem” has three parts:
1. In comparison to bare-metal stents, drug-eluting stents are fundamentally a quality-of-life
measure rather than explicitly life-saving treatment. In other words, there is no incremental
mortality improvement attributable to DES but rather a reduction in second surgeries for
restenosis.
2. Drug-eluting stents have a very small but definitely serious (e.g. fatal) risk of adverse effects
(namely long-term, in-stent thrombosis).
3. Mitigating this risk requires anti-thrombotic therapy, which actually masks the real rate of
life-threatening, in-stent thrombosis and also compromises some of the quality-of-life
improvement afforded by these stents.
This is a serious constellation of problems - metaphorically a “triple storm” - that has clearly caught the
eye of the industry and the FDA. Since the June article, three important developments have taken place
along the lines of increasing regulatory oversight, incrementally improving the current generation of DES
and leapfrogging the current generation with new technologies.
Increasing Regulatory Oversight
On Sept. 14, the FDA issued a statement that it would be convening a special meeting of its device
advisory committee. The committee was to assess the increasingly troubling reports of increases in rates of
death and cardiac events among patients with drug-eluting stents. The panel has been eliciting input from
the two primary manufacturers (Johnson & Johnson and Boston Scientific) and the plan is for definitive
recommendations to be issued by the end of 2006. As this is a nearly $6 billion market, there is obviously a
lot at stake. More important, an estimated 1 million DES have been implanted in patients in the U.S.
That’s potentially many lives at stake as well. On the other hand, as the FDA concluded:
The FDA believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved
indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of
1 of 2 11/17/2008 12:51 AM
Thinking about Life Sciences: Drug-Eluting Stents, Part One: Triple Stor... http://blog.aesisgroup.com//2006/11/27/drugeluting-stents-part-one-triple-...
Drug-eluting stents Johnson and Johnson device safety Aesis Research Group Ogan Gurel MD
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