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

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 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.