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Percutaneous coronary intervention (PCI) declared ‘better’ than drug therapy; readers worse off

Procedure plus medication is better than standard treatment for heart disease patients

Our Review Summary

This news release advocates for the benefits of a procedure to unblock coronary arteries called PCI or percutaneous coronary intervention. It involves snaking a catheter through a patient’s arteries to the site of the coronary narrowing; a metal stent is then inserted to help keep the artery open. The release claims that adding this procedure to drug treatment is “better” than the standard practice of offering drug treatment alone in patients with stable coronary artery disease (narrowing of the coronary arteries that produces chest pain when the individual exercises but is otherwise not a problem).

The basis for this definitive-sounding claim is the 5-year follow-up data from a study dubbed FAME-2. But there’s a problem: the FAME-2 data are far from definitive, and the news release doesn’t acknowledge any of the extensive limitations and caveats that must be applied to these results. The release also doesn’t mention potential harms of PCI, quantify the size of the apparent benefit, or disclose the many financial relationships the study authors have with companies that make devices to perform PCIs.

The result is an incomplete and one-sided portrayal of a complicated issue — a document that cheer-leads for a specific approach rather than fully informing the reader.

 

Why This Matters

The best way to manage patients with stable coronary artery disease is the subject of ongoing debate in cardiology. The highest quality evidence shows that PCI offers no benefit on objective outcomes like heart attacks and death. However, some experts believe that PCI is warranted based on its potential to reduce chest pain and related hospitalizations as suggested by FAME-2 and other studies, However, this notion has been called into question by the results of the ORBITA trial which suggested that, when compared to a placebo procedure, PCI did not decrease angina. Therefore patient and physician expectations around the benefit of PCI may be influencing the results of these types of analyses. There are also huge economic forces driving the continued use of PCI in the face of ambiguous evidence. The issue won’t be settled by news releases that declare one approach “better” than the other while failing to explore the evidence.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not address the cost of adding PCI to standard medical therapy. Nor does it mention the hypothetical cost savings that might accrue from avoiding hospitalizations in patients whose PCI procedures help avert heart-related complications.

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

Not Satisfactory

The release states that PCI resulted in a “significant reduction in urgent hospital admissions and revascularizations to restore blood flow in the blood vessels of the heart and a likely reduction in heart attacks as compared to medication as the only treatment.” However, it does not give any numbers that would help readers understand the size of the benefit we’re talking about.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release does not address potential harms of the PCI procedure. According to the NIH these include:

  • Discomfort and bleeding at the catheter insertion site.
  • Blood vessel damage from the catheters.
  • An allergic reaction to the dye used during the procedure.
  • An arrhythmia (irregular heartbeat).
  • The need for emergency coronary artery bypass grafting during the procedure (less than 3 percent of people). This may occur if an artery closes down instead of opening up.
  • Kidney damage caused by the dye used during the procedure.
  • Heart attack (3–5 percent of people).
  • Stroke (less than 1 percent of people).

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This news release makes the results of the FAME-2 trial sound like the last word on the subject of how to manage patients with stable coronary artery disease. But this is a misleading impression. Current standard practice is based on large randomized controlled studies which failed to demonstrate an advantage for PCI over standard medical therapy on the outcomes that people care about, such as heart attacks and death.

The FAME-2 study also did not demonstrate such benefits. The main benefit demonstrated in FAME-2 was a reduction in unplanned hospitalizations that led to PCI procedures. But this may be a biased outcome, because as the study authors point out in their NEJM paper, “the physicians, who were aware of the treatment assignments, might have been more likely to recommend a subsequent PCI procedure for patients in the medical-therapy group than for those in the PCI group, thus introducing a risk of bias for the end point of any revascularization.”

These and other critical limitations were omitted from the news release, which offers a blanket assessment that PCI is “better” than drug therapy alone. Patients aren’t helped by such black-and-white narratives. What’s “better” in one patient’s eyes may differ from another’s, and the calculus may depend on more than the risk of an unplanned hospitalization.

There’s also is a major limitation to the study that is easily overlooked. The study was about preventing revascularization (PIC) procedures, but all the patients in the intervention group underwent that procedure at baseline, so in total the people in the intervention group received more procedures, they just got them all up front rather than parsed out over time. So the therapy didn’t actually prevent anything since the intervention was also the outcome of the study.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering. The release appropriately calls attention to the grave toll of heart disease around the world.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release does well to notify readers that the study was initially sponsored by St. Jude Medical, a global medical device company. However, it should also have noted that many of the study authors individually have financial relationships with stent makers including St. Jude Medical, Boston Scientific, and Abbott.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release lays out the comparison of competing options appropriately. The debate surrounds medical therapy alone vs. medical therapy plus PCI.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

It’s apparent that PCI is widely available and that there is debate about when to use it.

Does the news release establish the true novelty of the approach?

Satisfactory

Novelty is appropriately established with this statement:

PCI is commonly used to treat sudden blockages of a coronary artery that cause a heart attack. In situations where the heart’s arteries narrow less suddenly and do not cause a heart attack but induce chest pain during exercise – a condition known as stable coronary artery disease – it has remained unclear whether PCI in addition to medication was better than medication alone in preventing future heart attacks.

If there’s a problem, it’s that the release makes it seem as though today’s standard practice is not evidence based or simply evolved based on trial and error. In fact, current practice is based on the results of large randomized controlled trials — and is still evolving.

Total Score: 5 of 10 Satisfactory

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