There’s nothing like a $5 billion-plus market to generate a lot of debate.Â With that much money hanging in the balance, there was already enough incentive to fire up opposing advocates on the sides of (1) bare versus drug-eluting stents, (2) CYPHER versus TAXUS, (3) bypass versus angioplasty/stenting, and countless other polemics without the results of a new study to make yet another comparison.Â The Courage study, published in the March 26, 2007 edition of the New England Journal of Medicine, compared the benefits of stents with the use of an aggressive regimen of medicines in patients with stable coronary artery disease. The bottom line?Â
“PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. ”
Given that that kind of statement is an “in your face” to the stent industry, one cannot be surprised at the reactions.Â According to WSJ, Donald Baim, CEO of Boston Scientific, dismissed the results as nothing new, saying it was an “unlikely thesis” that stents would have reduced the number of cardiovascular events (or death) in the long term and that the real benefit of stents has always been to improve the quality of life.Â That’s a bit disingenuous, isn’t it?Â It is a real stretch to believe that stent manufacturers have truly limited their promotion to the “quality of life” idea.
The study was controversial enough with the stakes this high.Â Â Â The study is also not quite definitive considering several facts.
- The study did not compare drug-eluting stents against optimal medical therapy, since the study preceded the release of the newer stents.Â Â Of course, this is not as big an issue as it might have been before the late-stage thrombosis problem of drug-eluting stents emerged and began causing interventional cardiologists to shift back to bare stentsÂ or, gosh, optimal medical therapy.
- There are countless drugs in development by companies who will willingly argue that “optimal” medical therapy has not yet even been developed, but will be soon.
- There may never be a “definitive” answer to the question of the “best” therapeutic option for stable coronary artery disease, since it remains a moving target in the crosshairs of multiple alternative technologies.Â In 2008, Abbott may well gain approval for its Xience stent, and other manufacturers’ drug-eluting stents are to follow.Â Â Needless to say,Â a new study would certainly be indicated at that time.
One reason why the Courage study has stirred things up so much is that the stable coronary artery disease segment of the stent market represents such a large share of the stent market (bigger arguably than the share represented by the use of stents following heart attacks or as an alternative in any case to more serious intervention, such as CABG) and is precisely the segment that “optimal medical therapy alone” targets.