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For most strokes, clot-retrieval device boosts effectiveness of drug treatment

Rating

4 Star

For most strokes, clot-retrieval device boosts effectiveness of drug treatment

Our Review Summary

This is an example of good medical reporting. This 865-word document provides the reader with sufficient background information to appreciate why the four studies (two published in the NEJM) are important and how they differ from previous studies. The economic realities of this type of procedure are noted along with its limited availability. The benefits could have been described in a more meaningful way, but there is some value in the information provided.  Our only major criticism is related to the lack of discussion about possible harms associated with the combination treatment.

[Note: As sometimes happens, this story was updated after it was first posted and includes new information not reflected in our review. Updates are important, but they miss the readers who only saw the original version, which is what we had already reviewed.]

 

Why This Matters

Stroke is a leading cause of morbidity and mortality in the US, accounting for about 1 out of every 20 deaths. In addition to the death toll, stroke is a leading cause of disability among survivors. The treatment of stroke changed radically decades ago with the introduction of alteplase, a clot busting drug, with increases in survival and reduction in disability. However, clot busters work best when given early and when the blood clot is located in small blood vessels in the brain. Blood clots in the large vessels place larger areas of the brain at risk and are much more difficult to treat with just a clot busting drug. The ability to remove the blood clot directly originally had great appeal. but earlier studies did not show a difference in outcomes. The studies reported on here finely tuned the timing of treatment, and very carefully selected patients who would be most likely to benefit from clot removal.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

We aren’t provided with any numbers, but the story does speak to the issue of cost. “But many centers, citing mixed findings on the devices’ benefits, have either abandoned or have been reluctant to offer the treatment, which is costly and complex to provide. Insurers, too, have been skeptical of the procedure’s value, and many refuse to reimburse for it.”

Cost would be difficult to pin down precisely for this procedure, since it varies by device type and by hospital, but it would have been helpful to provide a ballpark figure.

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

Not Satisfactory

This was a borderline call that we ultimately ruled unsatisfactory.  On the positive side, certain aspects of the two studies published in the NEJM are well described: “…among the 35 subjects who were assigned to get both treatments, 100% of the subjects’ brain tissue initially affected by blockage had blood flowing to it after 24 hours. Among the subjects who only got alteplase, also known as tPA, the median level of restored blood flow was 37%.” “The studies suggest that for every 2.5 to 4 patients, on average, treated with intra-arterial therapy, one could be expected to have an outcome better than they would have had with alteplase alone.”

However, percentage of brain tissue affected by blockage isn’t the most important outcome for readers — they’re more interested in results like neurologic function and death. And on those key statistics, the story relies mainly on relative risk figures that likely inflate the benefits of the procedure. Example: “Compared with stroke patients who got clot-dissolving medicine alone, those who got the two-pronged treatment were nearly twice as likely to regain some neurological function after three days, had 81% better function 90 days after their stroke, and were nearly half as likely to die.”

In these types of situations, absolute risk is the number that really matters to patients. So we’d prefer for the story to have reported 1. the percentage of patients who got clot-dissolving medicine alone and regained function, and 2. the percentage of those who got both treatments and regained function. That would give readers a more accurate sense of how well the treatment works.

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

Not Satisfactory

This is the one major flaw in the reporting from our perspective. Harms are not mentioned anywhere. Threading a catheter into a blood vessel in the brain to retrieve a clot and giving a clot buster are not totally benign procedures. The Australian study did not see any differences in the incidence of bleeding or worsening of symptoms whereas the second study saw a slight but statistically insignificant increase in bleeding in the group who received alteplase and the clot removal.  Importantly, the study was conducted in centers where there is considerable expertise and availability.  These results may not be transferable to all hospitals.

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

Satisfactory

The story provides adequate details for the reader to get a sense of the importance of the findings, although we think it could have provided a bit more of a counterweight to experts’ depiction of “game changing” and “overwhelmingly, unequivocally positive” results that were met with “standing ovations” at a conference. For example, the story could have noted that since all of the studies were stopped early, it’s likely that they overestimate the benefits of treatment. And for that reason, the real-world results will probably not be as eye-popping as the story suggests.

That being said, the story does include incredibly useful comments about hospitals’ readiness to perform these procedures in the way they were done in the study. Example: “There are a great many centers that will report they have the capability to provide these services,” said Mocco. “But there are truthfully relatively few that have put in the effort and expertise to create the comprehensive team-based work flow needed to rapidly evaluate and treat these patients safely and efficiently,” he added.

Does the story commit disease-mongering?

Satisfactory

The first sentence is attention-grabbing — “potentially devastating ischemic stroke” — but fair. We don’t see any disease-mongering of stroke.

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

Satisfactory

The story provides quotes from two experts in the field, neither of whom appears to be associated with the two NEJM studies. However, one of the sources — Dr. Sidney Starkman — has been an unpaid investigator on another trial run by a device manufacturer discussed in the story, and has disclosed in his previous writing that his employer (University of California) holds a patent on a clot removal device. Although it sounds like he stands to benefit if this technology becomes more widely adopted, we’re not really in a position to know the extent of his personal conflict of interest. We’ll give the benefit of the doubt here, with the caveat that it’s always useful to give readers a clear sense of the source’s independence (or lack thereof).

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does a good job discussing the different methods of treatment for stroke, and the disparity in the results seen in various studies.

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

Satisfactory

The story does a wonderful job highlighting concerns about the availability of the treatment offered in these studies.  We are told that only specialized centers have the expertise and technology available to perform the procedures,  and that insurance coverage has been spotty. The story also mentions the three clot retrieval devices that are approved for use in the United States.

Does the story establish the true novelty of the approach?

Satisfactory

The story provides a good deal of background information and discusses how the new study results are different from previous experience. Readers are told that the procedure cannot be done by all hospitals, and only very specialized centers are capable of performing it. We would have appreciated a bit more information on why experts think the new results are so different from those of previous studies. In other words, why did these treatments succeed now when they’ve failed to show benefit in the past?

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

Satisfactory

The story does not rely on a press release for its content.

Total Score: 8 of 10 Satisfactory

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