Feature: PCI, medical therapy for stable angina face off
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In the research published Feb. 28 in Archives of Internal Medicine, Kathleen Stergiopoulos, MD, PhD, and David L. Brown, MD, both of the Stony Brook University Medical Center in Stony Brook, N.Y., performed a meta-analysis that included eight clinical trials from the MEDLINE database between 1970 to September 2011. Their goal was to elucidate conflicting results from the literature regarding the best treatment options for stable coronary artery disease patients—PCI or optimal medical therapy (OMT)?
During the analysis, the researchers examined outcomes of death, nonfatal MI, unplanned revascularization and persistent angina.
What is new?
Brown said that the current analysis excluded study data that may be outdated such as those including balloon angioplasty or those where medical therapies did not reflect current clinical practice interventions.
A total of 7,229 patients were included in the analysis. The reported event rates for death with PCI and OMT were 8.9 percent vs. 9.1 percent, respectively. For nonfatal MI and unplanned revascularization, the rates were 21.4 percent vs. 30.7 percent and 29 percent vs. 33 percent for PCI and OMT, respectively.
“We found that compared to medical therapy, stenting did not reduce the risk of death, the risk of heart attack, the need for subsequent procedures or angina symptoms in the stable patient population,” Brown told Cardiovascular Business.
Brown added that the results should come as no surprise as they confirm what has been previously written in the guidelines: patients with stable symptoms should be first treated with OMT and referred for stenting only when symptoms remain unacceptable.
“This has been recommended before and is what the guidelines say but it has been shown that interventional cardiologists are not following this,” Brown said. “More than half of patients who receive stents for stable symptoms are not on optimal medical therapy, meaning that there is still a disconnect between the data, the guidelines and goings-on in clinical practice.”
“What more will it take to turn the tide of treatment?” asked William E. Boden, MD, chief of medicine at the Samuel S. Stratton VA Medical Center in Albany, N.Y., in an accompanying editorial.
“This is the big battle that has been raging since the COURAGE trial in 2007,” Boden said in an interview. Boden added that COURAGE was the first randomized study to show that there was no incremental benefit of PCI on top of OMT when compared with OMT alone (New Engl J Med 2007;356:1503-1316).
“This was not a very popular trial in the interventional community and they rose up in unison to attack its credibility,” he said. “The results were very much a surprise to many people—PCI would not be superior to OMT in this patient population and not be superior to OMT during long-term follow-up.”
Likewise two other trials—BARI 2D and the STICH trial—showed similar results. In BARI 2D, (led by Boden) results showed that in type 2 diabetic and heart failure patients randomized to receive PCI or CABG plus OMT or OMT alone, there was no difference in mortality between the two revascularization procedures and OMT (N Engl J Med 2009;260:2503-2515).
Boden said the current meta-analysis is more of an “apples to apples comparison” of contemporary treatments, which builds on the “mounting evidence that has shown that there is no incremental clinical benefit of PCI as compared with OMT in patients with stable angina and chronic coronary disease.”
Despite being well known and widespread, “this is an important message that continues not to be embraced by either the practice community or the lay public,” Boden said. “It continues to be the more dominate perception that despite the lack of evidence, PCI is still favored over OMT and people continue to push PCI rather than medical therapy.
“We continue to turn a blind eye on medical therapy and continue to under-treat patients who really should be treated with OMT,” Boden said.
Stergiopoulos and Brown found that only 44 percent of patients are treated with OMT prior to PCI. In fact, the authors said that up to 76 percent of patients with stable CAD can avoid PCI if first treated with OMT, which could result in a lifetime savings of nearly $9,450 per patient in healthcare costs.
“We are continuing to do all the things that the evidence shows us do not work and continue to avoid all the things that the evidence shows does work,” Boden said.
The OMT-PCI faceoff
“There is no information here. What this analysis has done is combine results that have been included in previous meta-analyses,” James C. Blankenship, vice-chairman of the PCI guidelines committee and interventional cardiologist at Geisinger Medical Center in Danville, Pa., told Cardiovascular Business in an interview.
“The people involved in this kind of work have understood the major conclusions of this analysis; and that is in patients who are stable and who are walking around as outpatients, stenting does not prevent heart attacks and doesn't make you live longer,” Blankenship added.
Blankenship and colleagues reviewed how PCI affects symptoms by looking at 20 different studies. During their analyses, Blankenship et al assessed how patients felt prior to and after PCI. “Virtually every one showed greater improvement after PCI than before,” he said.
He added that many patients included in the current meta-analysis were free of severe symptoms and said that patients who did show benefit of PCI were much more likely to have more severe angina symptoms. “If you take a group of patients who really do have symptoms and need relief and perform PCI, you will see a much better result,” Blankenship said.
“It's common sense that if a patient is not having symptoms, PCI is not going to make them feel much better,” he added. Additionally, he said that interventionalists know this information and that is evident by the fact that between 2005 and 2010 there was an 18 percent drop in the number of PCIs performed.
“We already have put these data into practice and have cut back on PCIs,” Blankenship said. “We are now practicing more conservatively, and the PCI guidelines do reflect and acknowledge the fact that there is no decrease in death and heart attack in stable patients who undergo PCI.
“So to Dr. Boden’s point, the message here is that people have gotten the message and are responding appropriately,” Blankenship said. “Everyone agrees that ideally with a heart artery blockage patients first receive aspirin, statins and beta-blockers, etc.”
Brown, Boden and Blankenship agree that education is most important in this process. Boden said that there is an “enormous educational gap between what the evidence shows and what the lay public believe,” while Blankenship offered that most still overestimate the benefit of the balloon stent.
“If a patient is having an MI, then by all means they should undergo PCI. No one quibbles with that,” Boden said. “But for the other 50 percent who have stable coronary disease for which there is not the same immediacy for treatment, all we are saying is why not OMT versus PCI for the initial therapy?
“The facts remain: we are continuing to do a poor job of treating patients appropriately in accordance with the evidence,” Boden added. “The big problem is that we have this pejorative attitude that medical therapy is ‘defective,’ ‘out of date,’ ‘old fashioned’ in comparison to stenting, which is thought to be ‘state of the art,’ ‘aggressive,’ ‘avant-garde,’ ‘high tech’ and ‘superior.’”
Boden summed that some of the educational myths and barriers to improve the lay public's understanding must be busted. “The lay public needs the answers to questions so they have an unbiased source.”