Major PCI Trial May Have Changed Practice

MedicalToday

The release of results from the COURAGE trial appear to have influenced the use of percutaneous coronary intervention (PCI) in patients with stable angina, at least in New England, researchers found.

The COURAGE trial compared optimal medical therapy alone versus optimal medical therapy plus PCI for patients with stable coronary artery disease. As reported at the American College of Cardiology meeting in March 2007, both arms had similar rates of death or MI through 4.6 years of follow-up.

Action Points

  • Note that this study suggests that in a regional Northeastern population, the publication of results from the COURAGE trial was temporally associated with a significant and sustained decline in the use of PCI to treat patients with stable angina.
  • Point out that this study cannot differentiate the cause of decrease in the use of PCI in a stable angina population between changes in interventionalists decisions and differences in referral to interventionalists.

After the trial results were released, there was a significant 26% relative decline in the number of PCIs performed for stable angina (P<0.01), with a much smaller drop in the numbers of PCIs for other indications, according to Bina Ahmed, MD, of the University of New Mexico in Albuquerque, and colleagues.

In addition, the percentage of all PCIs that were performed for stable angina peaked at 20.9% before COURAGE and fell to 16.1% shortly after the results were reported (P<0.01), the researchers reported online in Circulation: Cardiovascular Quality and Outcomes.

"Although other factors may have affected PCI volumes during this time period, the sharp drop in elective PCI came shortly after the COURAGE presentation and suggests a real effect of clinical trial results on physician behaviors," they wrote, noting that the long-term impact of this trend on patient outcomes remains unknown.

Ahmed and her colleagues examined data from 26,388 patients from the PCI registry of the Northern New England Cardiovascular Disease Study Group. The patients underwent PCI from January 2006 to June 2009.

The researchers identified 4,680 patients who were "COURAGE-like" -- they underwent an elective PCI, had an indication of stable angina, and had the procedure on the same day they were admitted.

The other 18,667 patients were placed in the "other" group.

Mirroring the trend in PCIs for stable angina, there was a significant decrease in total PCIs from 2,064 in the first quarter of 2006 -- pre-COURAGE -- to 1,708 in the third quarter of 2007 -- post-COURAGE (P<0.01). The trend was sustained through the end of the study period.

The authors noted that the decline in overall PCI volume started before the COURAGE results were presented, which they attributed to analyses from European registries linking drug-eluting stents with fatal stent thrombosis that were reported in August 2006.

That might have contributed to the response clinicians had to the COURAGE results six months later, they speculated.

But, they wrote, the fact that the percentage of PCIs performed for stable angina versus other indications declined after COURAGE "suggests there was an immediate and sustained impact of COURAGE on the practice of PCI in northern New England."

They noted that the impact may have been greater in regions where PCI for stable angina was more common.

Ahmed and her colleagues acknowledged some limitations of the study, including the conservative definition of PCIs for stable angina, the limited applicability to other regions of the U.S., and the lack of detailed information on the medial therapy regimens used before and after COURAGE.

In addition, they wrote, the findings came from a PCI registry, not a stable angina registry.

"The true impact of COURAGE would best be described by reporting on the changes in treatment strategies for this patient population including referral for catheterization," the researchers wrote.

Disclosures

The authors reported that they have no conflicts of interest.

Primary Source

Circulation: Cardiovascular Quality and Outcomes

Ahmed B, et al "Recent changes in practice of elective percutaneous coronary intervention for stable angina" Circ Cardiovasc Qual Outcomes 2011; DOI: 10.1161/CIRCOUTCOMES.110.957175.