Medical Device Daily Executive Editor

While Johnson & Johnson/Cordis (New Brunswick, New Jersey/Miami Lakes, Florida) is likely to dump reams of copies of the new Lancet report on stenting into the brief cases of their sales reps, this is likely to be only added marketing ballast. The article is unlikely to produce a large up-spike in either Cypher use or DES use as a whole, an area significantly hurt over the past several months with a variety of sector-bashing reports.

J&J/Cordis, of course, will aggressively banner the primary findings, i.e., that its Cypher did better in key endpoint categories over both Taxus from Boston Scientific (Natick, Massachusetts) and BMS devices (lower rates of thrombosis/death and lower rates of restenosis), but the entire report tends to, again, throw a rather wet blanket over the entire DES sector.

Extending the metaphor, the report rains on an early parade that had bannered these devices as “breakthrough,” “revolutionary,” “disruptive.” With reports of the initial clinical studies of these devices, these superlatives came in waves and have turned out to be not just hype, but over-hype.

While the Lancet report offers a bit more of this, we predict it is not likely to sway the interventional cardiology community or greatly change their current practice.

The reasons are threefold:

The new study is a meta-analysis of several studies, a type of study so suspect as to methodology and detail as to make even the least skeptical wonder about conclusions. While we don’t doubt that The Lancet applied considerable rigor to evaluating study methodology, even the best meta-analysis will have a variety of built-in flaws.

In this case, the flaws are in the fact that that the analysis looked at carefully constructed clinical trials, rather than focusing on real-world outcomes, and since they were the earliest trials, they were almost certainly company-sponsored rather than independently funded efforts. Additionally, all of these trials were in relatively small populations, another factor casting doubt on the conclusions — a point about trials in general that is being highlighted repeatedly at this year’s meeting of the Heart Failure Society, ongoing this week in Washington.

The conclusions of the study, apart from what they say about differences between Cypher and Taxus, also fail to provide any boost in the reputation of DES devices, which were touted as being so superior to BMS devices in terms of restenosis.

The original reports constantly put the need for redo because of in-stent restenosis following BMS implant at 20% to as high as 30%, while DES implant studies reported redo data as low as 3% to 5%. That math doesn’t match up well with the meta-analysis that now says DES restenosis and the need for follow-on procedure is 50% of that required by BMS implant.

This is a significant difference but doesn’t indicate great cost-effectiveness of DES devices, which run to more than two-and-one-half times the cost of a BMS device.

Additionally, some studies, and their interpretation by the interventional community, have cast doubt on restenosis shown by angiography as not all that clinically significant anyway.

And, finally, the Lancet report indicates that there is no great difference between DES and BMS in what clearly must be the most significant endpoint for the patient: added months/years of life.

This is an endpoint obviously unavailable in the earliest short-term trials, but the unconscious assumption by most probably was that, well, if DES devices reduce restenosis, they must serve to reduce heart failure symptoms and reduce the rate of death from heart attack or heart failure.

But they don’t, according to the Lancet study.

The meta-data has been served up as a way of reducing the fears of thrombosis/death from DES, but the numbers don’t underline any sort of rubber-stamped marketing view that DES is a wonder technology described as “revolutionary.”

Finally, if DES is an advance, it is one most likely to be seen not in the 2.0 editions of this technology, but those likely to come on the market next year — none of these from the makers of the Cypher or the Taxus. This is perhaps the main reason why DES will remain in its current slump.