Medical Device Daily Executive Editor

NEW ORLEANS — The full-court press.

Here in the U.S. — where college basketball is at the height of its athletic, and betting, frenzy — the term full-court press means an all-out defensive effort that a team uses in the hope of gaining superior offensive advantage.

But this week, the term could just as accurately be used to describe the flurry of activities by Boston Scientific (Natick, Massachusetts) at this week's conference of the American College of Cardiology (ACC; Washington), as it fends off concerns about drug-eluting stent (DES) technology and its own somewhat stagnating position in this sector.

A stiff defense is certainly needed as reports of late-stent thrombosis, the lack of life-extending benefits from DES as compared to bare metal stent (BMS) technology, and a steady push-back by advocates of coronary artery bypass grafting procedures, as in many cases still superior to stenting, have all conspired to cast a clinical and marketing pall over the DES sector and depressing sales.

Thus, the company is using the meeting as a platform to launch a variety of defensive initiatives to regain the higher ground and convince the interventional community that both DES and its own Taxus DES product are safe, effective and remain in the forefront of both stenting modality and superiority to CABG.

The initiatives are all over the competitive court at the ACC:

Item: On the eve of the meeting, Boston Scientific rolled out its program for emphasizing the need to maintain post-DES implantation patient compliance with anti-platelet therapy (Medical Device Daily, March 26, 2007). The initiative promises the development of a targeted educational effort for all DES-implanted patients, not just those implanted with its Taxus stent, along with promises to help those who may have trouble paying for anti-platelet pharmaceuticals to find the necessary adjunctive funding.

Item: The company runs a full-page ad in this week's issue of the Journal of the American Medical Association — headed "The safety and efficacy of the TAXUS Stent are clear." — an issue which finds multi-dozens of placements in the news media work room. And the same ad appears in the Journal of the American College of Cardiology, distributed to all attendees.

Item: The company issues an update (43 pages) of a previous White Paper providing a broad overview of the recent history of the concerns about DES, that paper summarizing a variety of studies and concluding that they support the efficacy of DES and Taxus. The report includes repeat promises concerning the evaluation and follow-up study of Taxus in a variety of ways, concluding: "Finally, Boston Scienific strongly believes that a deep understanding of DES outcomes is essential for appropriate patient education and treatment.

Item: The company holds a media briefing during Sunday's session at a hotel near the Ernest Moriel Convention Center conference Centere site, that briefing featuring a presentation by David Baim, MD, the company's chief technology officer. Baim summarizes much of the material provided in the White Paper but provides an overlay explanation concerning the current state of the DES debate.

His explanation is that the debate has been largely fueled by media coverage tending to focus over much on "alarming outlier studies" that highlight DES difficulties, with the media failing to put these against the broader context of the many trials indicating broad safety and efficacy.

Baim's presentation verges on a "kill the messenger" approach — that messenger being the press — but he tempers this by giving his media critique a somewhat more philosophical texture.

He describes the anti-DES reaction as basic and understandable process of risk aversion to a threat rather than "analytic-based." But he goes on to predict that with further study rationality will prevail.

But Baim's interpretation of a too-easily frightened public — and by implication also the clinician public — didn't reflect various presentations made elsewhere at the ACC conference.

For instance, at a symposium during Saturday's initial presentations, a group of panelists didn't seem to be targeting media hype as the primary cause for concern in the debate but rather too much early hype on the part of industry.

Thus, Martin Leon, MD — a physician very prominently connected with the pre-FDA approval promotion of DES as a "disruptive" technology that would positively alter the artery-clearing game — said that many in the cardio community "were overly seduced by the initial angiograms" and the initial short-term studies concerning the benefits of DES.

Other symposium panelists underlined what appears to be a group of consensus views about the use of DES: the 60% rate of off-label use as a problem since producing the most difficulties in terms of adverse event and analysis; and the continuing need to link DES with the difficult but appropriate regimen of anti-platelet medication, given poor patient compliance.

Other speakers noted the continuing important role of CABG procedures in the most complex cases and the need for a more accurate discrimination among patient cases for determining appropriate therapy.

Will Boston Scientific's full-court press work? Will it result in an upward spike in DES and Taxus use?

We bet not.

We think that what is going to happen is that the game will change over the next year or so, that both Cordis's Cypher and Boston Scientific's Taxus, while not dead in the water, are going to be treading water as the medical community waits for the second-generation devices to be introduced. And that the debates will then probably become even more complex and no less heated as more products and players get into the game.

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