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Drugs may make stents deadly, study says

Rating

2 Star

Drugs may make stents deadly, study says

Our Review Summary

First, this is a review of a story originally reported by the Milwaukee Journal, which was picked up – and shortened – by the Seattle Times.

This story presents the results from a recently published study comparing the formation of new collateral blood vessels to provide the heart muscle with blood in patients with bare-metal and drug-coated stents. The study found that people with the drug-coated stents had less formation of these vessels.  The implication of this was not clearly presented in the story, but with fewer vessels formed, if vessels become blocked, there is less capacity to provide the heart muscle with blood. So there is increased risk of heart muscle damage and death.

The story neglected to present the complete array of treatment options for the management of coronary artery disease and did not provide the reader with information on the guideline criteria for the use of stents.  This information is necessary for the reader to understand the interventions available for coronary artery disease and to help them with treatment decisions they may face.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no mention of the costs for drug-coated stents or bare metal stents.

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

Not Satisfactory

The story fails to quantify the benefit of decreased incidence of re-stenosis with the use of coated-stents as opposed to bare-metal stents.

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

Not Satisfactory

The title of the article "Drug may make Stents Deadly" is about the increased risk of fatal blood clots associated with the use of coated-stents and towards the end of the story, the actual magnitude of that risk (ranging from 0.6 to 2.6 % of patients) is presented.   However, the story fails to quantify the harms associated with the use of plain metal stents.  It does mention that the risks of re-stenosis after implantation of a plain metal stent is higher than with coated stents, though the story does not provide any information about the size of the risk nor the magnitude of the difference when comparing these two treatment options. 

The story did not clearly present the risks associated with the use of bare-metal stents.  It did not outline the difference in risk of re-stenosis and thrombosis for these two medical devices.

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

Not Satisfactory

The story stated that patients with drug-coated stents had 30 – 40% less collateral blood-vessel function than those with bare-metal stents.    It is really not possible to interprete this relative change in the absence of the absolute difference nor some idea of how much collateral blood vessel function is needed for optimum protection. The story owed it to readers to dig deeper and explain this.  

Does the story commit disease-mongering?

Not Satisfactory

 The story did not do a good job of explaining the problem presented in the opening paragraph, i.e. the formation of blood clots were more likely lethal in individuals receiving drug-coated stents.  It would have been helpful to more fully describe the development of collateral circulation to provide blood supply to the heart muscle and how less collateral circulation increases the risk to the heart muscle when a portion of the blood supply to the heart muscle is blocked by a clot.

Because the story did not explain when the use of a stent is indicated or not, this piece has a disease mongering quality.

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

Satisfactory

The story quotes on3 of the authors of the study reported on as well as an investigator in the field who has no obvious connection with the study.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

While presenting information supporting a hypothesis for why there is an increased risk of blood clots in the coronary arteries of people who have a coated stent as opposed to a bare metal stent, the story did not do an adequate job of presenting the treatment options of individuals with partial blockage of coronary arteries – i.e. the story failed to mention the role of medical therapy either without stenting or when stent placement is followed by medical therapy.

Although the story did mention that it was important for "doctors to make sure they have selected the correct stent for" the patient, it would have been more helpful to provide some guidance to readers about how to talk with their doctors to remind them about selecting the stent that is appropriate for that particular patient.

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

Satisfactory

The story presented an estimate that 80% of Americans who are treated with a stent receive a drug-coated stent (as opposed to a bare metal stent).  The story did, however, neglect to mention what the indications are when a stent (whether bare metal or drug-coated) is recommended.

Does the story establish the true novelty of the approach?

Satisfactory

This is a story reporting on the observations from a new study.

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

Satisfactory

Does not appear to rely on a press release

Total Score: 4 of 10 Satisfactory

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