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FDA Probes Safety of Popular Heart Stent

Rating

5 Star

FDA Probes Safety of Popular Heart Stent

Our Review Summary

When drug-coated or durg-eluting stents went on the market, they immediately changed clinical practice by replacing the standard bare metal stents. The purpose of the drug-coated stent was to prevent the clogged artery from becoming clogged again. However, new reports are emerging that these stents may actually be causing some clots to form. Enough evidence is mounting that the FDA convened a panel to discuss how these new developments will affect how stents are used in routine practice. This story does an excellent job of describing the scale of the problem and quoting multiple experts who fall on different sides of the debate.

The story does a good job of describing the strength of the available evidence, particularly the limitations of using hosptial registries as a source of data. By accurately describing the prevalence of coronary artery disease, the story avoids disease mongering. Furthermore, the story mentions alternatives such as bare metal stents, bypass surgery and medications. The story also describes the cost of the drug-coated stents compared to the older version, the bare metal stents.

The story does report the risk of clotting with the drug-coated stents, however the comparison of coated and bare metal stents is the key piece of information that is missing in this story. This information should also be presented in absolute rather than relative terms.

Overall, this was a balanced and comprehensive piece. 

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story describes the cost of the drug-coated stents compared to the older version, the bare metal stents.

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

Not Satisfactory

The story does report the risk of clotting with the drug-coated stents, however the comparison of coated and bare metal stents is the key piece of information that is missing in this story. This information should also be presented in absolute rather than relative terms.

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

Satisfactory

The story adequately describes the risk of clotting with drug-coated stents and of bleeding with Plavix.

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

Satisfactory

The story does a good job of describing the strength of the available evidence, particularly the limitations of using hospital registries as a source of data.

Does the story commit disease-mongering?

Satisfactory

By accurately describing the prevalence of restenosis, or narrowing of the artery after stenting, the story avoids disease mongering.

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

Satisfactory

The story quotes multiple experts who have differing perspectives on how the new information changes clinical practice.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does mention alternatives such as bare metal stents, bypass surgery and medications.

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

Satisfactory

The story clearly states that drug-coated stents are common.

Does the story establish the true novelty of the approach?

Satisfactory

The story clearly states that the drug-coated stents are new but have been widely used since they were introduced.

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

Satisfactory

Because the story quotes multiple independent sources the reader can assume that the story does not rely on a press release as the sole source of information.

Total Score: 9 of 10 Satisfactory

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