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In Test of Stents, Old Standby Wins Out

Rating

4 Star

In Test of Stents, Old Standby Wins Out

Our Review Summary

Our review names some story elements that we think could’ve been added or removed. To us, the most notable omission was the litany of financial conflicts of interest the researchers had with stent manufactures.

 

Why This Matters

While coating metal stents with drugs has reduced the odds that the arteries will clog again, they have the downside of requiring much longer courses of dual anti-platelet drugs, which increases the risks of bleeding. And that bleeding risk becomes a particular issue for people who need to undergo other surgeries. There are, thus, tradeoffs to consider in the choice between bare and coated stents, motivating the development of new ways to coat them.

This article mentioned good points about a new trial comparing three types of coated stents. Cardiac revascularization is a complex topic with an avalanche of literature, and it’s impossible to simplify or encompass all the issues in a piece of the length. We do congratulate this article for summarizing the study with balance, including pointing out its key limitation.

However, overall, the constraints of space and complexity of the topic combine to yield a relatively technical article, where terms like re-stenosis, eluting, and different polymers are not defined directly. And without the context that would’ve come from a longer discussion, the article leaves unanswered for lay readers key questions about the relevance of this research, such as:

  1. Who gets stents anyway?
  2. Does everyone who gets a stent get the ones coated with drugs?
  3. What’s the downside of prolonged dual antiplatelet therapy? Why is that a “but…” when choosing coated stents?
  4. Is the fourth paragraph saying that the new stents in this study were designed to reduce the need for prolonged drug therapy? Or is that unrelated to this study?

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Costs aren’t discussed.

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

Satisfactory

The article gives the absolute rates of major adverse cardiac events for each treatment group. 

Also, while this is likely not a major issue for most readers and not an official strike against the article, as an FYI we point out that there are some interwoven concepts that can be confusing. The article’s headline is that SES won this contest. If you want to get technical, there are two buts. First, while SES did have the fewest cardiac events of the 3 stents, the difference with ZES wasn’t statistically significant. In other words, the apparent superiority of SES may have been do to chance. Or not. We don’t know. Researchers call this a trend but not significant evidence.  Second, this contest, the study, wasn’t designed to answer whether SES was the best. The researchers concluded, as quoted in the story, that this study answered two main questions: ZES and SES were similar, and ZES fared better than PES did. Notice it didn’t say SES was the best. 

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

Not Satisfactory

There’s overlap between harms and benefits here because stents are designed to prevent harm. However, the study identifies the development of blood clots on the stent as a safety outcome (along with the numbers of heart attacks and death). While the article tells us that the rate of clots was significantly lower with one type of stent, it does not quantify the harms.

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

Satisfactory

There are some valuable details about the study in this article, including the number of subjects, the 3 treatment arms, randomization, the follow-up period, a definition of the endpoint—a composite called “major adverse cardiac events”—and what actual events that means. It gets kudos for identifying the key limitation of the one-year follow-up with a nod to important results from a longer ongoing study.

There were some aspects of the evidence missing, which is not surprising in a short article about a fantastically complex topic. In a quote the researchers laud their study as a “practical” one. We’re not told what that means. And see our comment under Benefits regarding the explanation of the results.

Also, an article of this length doesn’t have the real estate to go into all the nooks and crannies (and limitations) of composite endpoints, like MACE, which are very standard in such trials. But we appreciated that the author unpacked it a bit by noting that rates of death and heart attacks did not differ. 

Does the story commit disease-mongering?

Satisfactory

We give the article a Satisfactory rating because, in this very focused and balanced review, it doesn’t balloon the target population for drug-coated stents.

That said, we would’ve liked to have seen at least some overview of who is a candidate for stents at all, bare or coated. Not everyone with a clogged artery gets stents, or, rather, should get stents based on the evidence. It’s a complex topic, with different guidelines for those having heart attacks and those with stable angina, but it’s also a hot topic these days due to widespread misconceptions about who gets stents and what benefits they actually have. Recent evidence, such as the COURAGE trial, suggests that for most people with stable angina, stents don’t prevent heart attacks or improve survival compared to only taking medicine and leading a heart-healthy lifestyle.

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

Not Satisfactory

One source, Dr. Fonarow, was apparently not affiliated with the study. We appreciated his placing the results in context with prior research and on clinical decision-making. Google tells us that he has a financial relationship with the company that makes zotarolimus-coated stents. But given the fact that his quotes—and the study—are not in favor of zotarolimus, perhaps the lack of this disclosure is excusable.

One key conflict of interest, study funding from a stent manufacturer, was identified. However, we fail the article on this criterion because it neglects to mention that the researchers disclosed a web of financial relationships with literally all the stent manufacturers. We count 9 financial relationships with Cordis, who makes the sirolimus-coated stent, which came out “on top” in this article.

Does the story compare the new approach with existing alternatives?

Satisfactory

Taking into account that the article implies availability of the 3 stent types, the study itself was comparing a newer approach with the “old standby.”

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

Satisfactory

The article could’ve been more explicit about the availability of these 3 stents, but the last sentence describing the study’s real-world implications, suggests that all 3 are currently available in cath labs.

Does the story establish the true novelty of the approach?

Satisfactory

The article explains that the three stents are coated with different drugs, the zotarolimus version is a newer entry, while the sirolimus one is the “old standby”.

It would’ve been nice to read how the stent with paclitaxel fits into the big picture.

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

Satisfactory

We didn’t find evidence that this article relied on a news release.

Total Score: 7 of 10 Satisfactory

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