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AP takes pains to point out lack of long-term data for new dissolvable stent

Rating

4 Star

FDA approves first dissolving stent for US patients

Our Review Summary

heart stent surgeryFDA approval of a dissolvable stent sets the stage for wide use of a device that may—emphasis on the “may”—reduce complications in heart disease patients whose blocked arteries are treated with more typical metal stents.  This story offers us that news peg but quickly and decisively tells readers that information about the long-term benefits, as well as the safety, of these new stents is still missing in action.

That important warning should be of great use to heart disease patients and is nowhere to be found in a Reuters story about the FDA decision, which reads more like a celebratory press release.

That said, two things we’d have welcomed in this story: First, a frank discussion about what patients should do if they’re facing stent placement–do they typically have any choice in what kind of stent they receive? Is it reasonable to refuse this method until more data is in? And second, what is the actual material used in the stent, and is it used in other medical devices?

 

Why This Matters

Metal stents have safety concerns, primarily higher risks of blood clots that could lead to heart attack.  If dissolvable stents serve to minimize that subsequent risk, they would indeed constitute an improvement over current metal stents. But no one knows if this is the case yet — and this story’s open discussion of the unknowns makes it rise above many competitors’ stories.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

This piece does an admirable job of providing cost information in the face of reluctance by Abbott Labs, the stent’s designer, to disclose such information. The reporter, instead, offers readers a sense of the typical hospital bill for “stenting procedures.”  You will not be surprised to learn that such surgery is not cheap at about $30,000.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

A major message of this story, to its credit, is that the benefit of these dissolving stents has not yet been established–there is no data yet. This is important, because the whole point of designing a dissolvable stent is to minimize longer-ranging complications resulting from metal stents.

The story does briefly describe a company-conducted study. It says “patients who got Absorb fared about as well as those receiving Abbott’s older metal stent after one year.” However, we’re not told really what that means in terms of survival and reduced cardiac events.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The text offers a list of complications found with the new device, apparently recorded in the clinical trial: allergic reactions, infections, internal bleeding. And it gives us quantified information on “heart-related complications” for both the dissolvable and metal stents.

But the story’s main message is that we simply do not know if these stents cause complications over the long term.  It does quote a source who helped conduct the clinical trial for Abbott and who describes the “theoretical” reason for the new stents as allowing arteries to return to their “normal” shapes after the stents dissolve and, thus, prevent the kinds of problems that afflict permanent mesh stents, including a higher risk of blood clots.  But the only study mentioned by the story, and by Abbot Labs in a news release, lasted a single year, while the stents are designed to completely dissolve over the course of three years.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The one-year study conducted by Abbott Labs is summarized in this story, but not explained in enough detail to permit a reader to judge its quality.

Does the story commit disease-mongering?

Satisfactory

No disease mongering here. Permanent mesh stents have complications, so the search for an alternative is useful.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

Both of the sources—one who conducted the research testing the stent and one who advised the FDA—are clearly identified, as is Abbott Labs as the creator and presumed funder of the stent. A financial analyst is also included.

This is sufficient for a Satisfactory rating, though none of these sources represent the ideal of what we’re looking for–a medical expert who is independent of the research and the stent’s FDA approval process.

Does the story compare the new approach with existing alternatives?

Satisfactory

The reporter’s efforts to emphasize the long-term safety questions of this new stent lead her/him to make clear comparisons between the dissolvable stent and both metal stents and drugs.  For example, at one point the story notes that recent research showed that treating chest pain with drugs leads to outcomes similar to those that result from use of stents.  Missing from this comparative information are the efficacy of metal stents with polymer coatings that deliver a drug to prevent arterial re-clogging.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The news peg for this story was FDA approval of the device for patients with coronary artery disease.  But although the Abbott Labs’ press release suggests that the dissolvable stent is available worldwide (“in more than 100 countries, including the United States”), the story does not mention U.S. access to the device. The Reuters story covered this criterion better.

Does the story establish the true novelty of the approach?

Satisfactory

The story makes it clear what is new about this type of stent.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story’s emphasis on the lack of long-term safety data is a strong departure from the information provided in the Abbott Labs press release.

Total Score: 8 of 10 Satisfactory

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