The COURAGE Effect: Sustained Decline Seen in PCI for Stable Angina

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The source of much controversy when the results were first presented and published, the COURAGE trial has had a long-lasting impact, resulting in a sustained decline in percutaneous coronary interventions (PCI) for patients with stable angina, according to a large regional study published online April 19, 2011, ahead of print in Circulation: Cardiovascular Quality and Outcomes.

The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial assessed optimal medical therapy with or without PCI for patients with stable CAD, finding equal rates of death and MI in the 2 treatment arms. The results were presented at the American College of Cardiology Annual Scientific Session in March 2007 and published in April 2007 in the New England Journal of Medicine (Boden WE, et al. NEJM. 2007;356:1503-1516).

Researchers led by Bina Ahmed, MD, of the University of New Mexico School of Medicine (Albuquerque, NM), sought to determine the long-range effects of the COURAGE trial on practice patterns by analyzing over 26,000 consecutive patients from the northern New England Cardiovascular Disease PCI Registry who underwent PCI between January 2006 and June 2009. The researchers zeroed in on a “COURAGE-like” patient group (n = 4,680) that underwent interventions for stable angina and looked at different trends in procedure volume, comparing the time periods by quarter before and after release of COURAGE.

PCI for Stable CAD, Other Indications All Drop

There was a 17% relative decrease in PCI for stable angina in Quarter 2 2007, when COURAGE was released, compared to pre-COURAGE Quarter 1 2006. There was a further relative decrease of 25% by Quarter 4 2007 (P < 0.001), which was maintained through the end of the study period (P for trend = 0.01). The peak relative decrease in PCI for stable angina during this time period was 26%.

For patients undergoing PCI for other indications (n = 18,667), there was a pre-COURAGE decrease of 9% in Quarter 4 2006, declining another 6% post COURAGE in Quarter 3 2007. This cohort rebounded to 10% below the reference level in Quarter 4 2007, persisting at that level over the remainder of the study period. These patterns were similar across all 9 of the enrolling sites within the registry and for different patient subgroups including men and women and patients under or over 65 years of age.

Procedure Volume Contracts, Percentages Shift

As a percentage of all PCI, stable angina reached a high of 20.9% in pre-COURAGE Quarter 2 2006 and decreased sharply after publication of the results in Quarter 2 2007 to 16.1% (P < 0.01). Meanwhile, there was a reduction in overall PCI volume from 2,064 procedures in pre-COURAGE Quarter 1 2006 to 1,708 in post-COURAGE Quarter 3 2007 (P < 0.01), translating to a relative reduction of 16% that was maintained through June 2009.

Patient characteristics were similar in the pre-COURAGE era vs. 6 months after publication, showing no differences in age, sex, comorbid conditions, and cardiac history. Patients treated after the publication of COURAGE were more likely to receive complete revascularization (72.0% vs. 59.9%; P < 0.01) and less likely to receive DES (68.3% vs. 78.2%; P < 0.01). There were no in-hospital deaths or emergency CABG surgeries in the entire cohort for this comparison.

According to the authors, the magnitude of the drop in PCI for stable angina relative to overall PCI, as well as the timing, “suggests there was an immediate and sustained impact of COURAGE on the practice of PCI in northern New England.”

In addition, since according to the study on average only 17.7% of all PCI procedures are performed for stable angina in the region, “it is conceivable that this impact would be more pronounced in regions where PCI for stable angina is more prevalent,” they add.

The ‘Perfect Storm’

The timing of COURAGE may also have been important, as data focusing on DES and stent thrombosis were presented at the annual European Society of Cardiology (ESC) meeting in August 2006, helping lead to a downward trend in DES use and overall PCI procedures in the months prior to COURAGE.

COURAGE principal investigator William E. Boden, MD, of Buffalo General Hospital (Buffalo, NY), agreed that the study came out during a “perfect storm” that included the ESC data as well as US Food and Drug Administration hearings regarding DES all within a few months of each other. However, since that time, fears regarding the safety of DES have been shown to be largely overstated, he said in a telephone interview with TCTMD, and use of the devices has rebounded in the United States.

“So the question would be, why haven’t the rates of PCI gone back up in stable coronary disease?” Dr. Boden said. The reason may partly stem from COURAGE, he noted, but it is also due to something else. “I think the explanation is that physicians are having more confidence or belief in optimal medical therapy, and maybe that has raised the threshold and caused physicians to not as quickly refer patients for catheterization and PCI,” Dr. Boden said. “What I’m hearing from our practicing cardiologists is they’re seeing people doing better and better on medical therapy. Their symptoms are improving, and that will obviously decrease the need for PCI.”

He added that from what he has seen in his own institution as well as elsewhere, the paper is representative of a national trend that has seen a roughly 15% to 20% decline in PCI for stable disease.

Muddling the Message

However, Jeffrey W. Moses, MD, of Weill Cornell Medical College (New York, NY), expressed concern that the message of COURAGE may have been misapplied at times, as evidenced by the overall drop in PCI, not just for stable disease.

“The message was that there’s a segment of patients who don’t necessarily need angioplasty: those with mild symptoms or mild ischemia,” he told TCTMD in a telephone interview. “But what’s happened is the message has gotten muddled so people aren’t even doing catheterizations, and in COURAGE everyone was catheterized before they got triaged, so really bad disease was excluded. Anyone with moderate or severe symptoms or moderate or severe ischemia does better with PCI.”

Dr. Moses added that the drop in PCI volume for stable disease may have been warranted. “But on the other hand, PCI was underutilized in other situations,” he said. “People ask me, is there too much or too little PCI going on, and I say, ‘Yes.’”

Dr. Boden did not disagree. “I think the problem with any trial that’s provocative is that depending on your perspective, you can emphasize one interpretation and in some respects kind of inadvertently deemphasize where there’s proven benefit of PCI,” he acknowledged. “Clearly, the patient with severe ischemia who may have chronic angina will likely benefit from PCI. That message could get a bit blurred.”

Medicine by Sound Bite

Another area where Drs. Boden and Moses agreed was regarding the culpability of the media, which the study also cites. “Results of major trials and resultant media coverage can have substantial impact on clinical practice,” the authors write.

“It certainly had a short-term impact,” Dr. Boden said. “The media love controversy, they’re like a dog with red meat. The problem is that when the media jump on anything, patients or the lay public often can’t discriminate between stable or unstable angina and acute MI, so when something like COURAGE comes out, the media paint everything with a broad brush.”

“It’s a shame, honestly, because it’s called medicine by sound bite, and that’s why COURAGE is often misapplied,” Dr. Moses said. “They said, well, COURAGE showed angioplasty is no better than medical therapy, but that’s not what it showed. The study showed in a select group of patients there’s no benefit. It’s called evidence-based medicine, but are they really applying the evidence in the study, or are they applying the sound bite? That’s the big question.”

 

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Source:
Ahmed B, Dauerman HL, Piper WD, et al. Recent changes in practice of elective percutaneous coronary intervention for stable angina. Circ Cardiovasc Qual Outcomes. 2011;Epub ahead of print.

 

 

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