Thinking about Life Sciences

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Thursday, July 19, 2007

Bleeding stents ... Is the drug-eluting stent era over?

An article bySteve Syre in today’s

Boston Globe

– “Bleeding stent sales” (and picked up byDeviceTalk ) noted the rather precipitous decline in drug-elutingstent sales during the past year. J+J, for example,reported adrop of 41% in the second quarter of this year alone. Two things:(1) this reversal of fortune was predictedlast year in a series of articles in this blog and (2) this further validates the concept of drug-eluting stents asbeinga “transitional” technology.Steve Syre’s title “Bleeding stent sales” is about as pithyas it gets. The problem – as anyone who has beenfollowing the sector knows – is the small,but significant rate of in-stent thrombosis over the long-term thathas been seen with drug-eluting stents (DES). To put it in layterms, basicallythe region around the stentremains, for reasons not entirelyknown,somewhat unstable and prone to clotting up (thrombosis). Such anadverse effect is veryserious and, in fact, not uncommonlyfatal.

Problems with drug-eluting stents predicted last year

Aseries of articles last year highlighted this safetyproblem and when put in context with the increasingimportance of safetyin general (not just with DESbut across-the-board in pharmaceuticals and medicaldevices), a “triple storm” was developing that significantlyput at risk the growth projections for the DESmarket. In fact, as the

Boston Globe

article highlighted, there has been a decline in sales for several of thecurrent DESmanufacturers. Those articles can be found at:

The Future of Drug-Eluting Stents: ABig Issue or a Non-Issue?

(26 June 2006)

Drug-Eluting Stent Market: $5 Billion Turning on a Dime

(24 July2006)

Drug-Eluting Stents, Part One: Triple Storm Catching Industry Attention

(27 November2006)

Drug-Eluting Stents, Part Two: Triple Storm Catching Industry Attention

(28 November2006)The upshot is that the current decline in DESsales should not be a surprise, given that drug-eluting stentsare essentiallyserve to improve quality-of-life, and that in this regard safetyissues become increasinglyrelevant in terms of outcomes and patient benefit.

Drug-eluting stents as a Quality-of-Life measure

It has been demonstrated that drug-eluting stents are highlyeffective in preventing “

restenosis

” (or agraduallynarrowing of the artery) after the initial angioplastyand stent implantation. It should be notedhowever, that restenosis affects a patient’s qualityof life bycausing pain and often requiring a repeatprocedure (revascularization). Because of this,it should not be surprising to learn that drug-eluting stentsactuallyhave

not

been shown to improve survival (e.g. save lives) relative to bare-metal stents. Hence DESis essentiallya treatment that improves quality-of-life.

In-stent thrombosis is a problem

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