November 12, 2008 (New Orleans, Louisiana) — A recent survey of patients who underwent elective PCI for angina relief suggests that at least two-thirds of them believed that the procedure would actually extend their lives, and even more believed that it would prevent future MI. According to Dr John Lee (Mid America Heart Institute, Kansas City, MO), who presented the data here at the American Heart Association 2008 Scientific Sessions, the findings raise the question of whether patients are truly providing "informed consent" if their understanding of the risks and benefits is so imperfect.
Lee points out that while PCI has been proven to reduce the risk of MI and death in acute coronary syndromes, in the elective setting PCI has been shown only to relieve angina and improve quality of life, as shown in the recent COURAGE trial. But according to these new study results, "Patients' perceived benefits of an elective PCI do not match existing evidence," he said.
For the study, Lee et al sent survey questionnaires to almost 500 subjects who had undergone elective PCI between January 2006 and October 2007 in Kansas City, MO; 350 responded. In addition to the misconceptions about effects of PCI and survival and MI risk, patients also tended to think that their PCI was an emergency procedure, despite the fact that all were elective. Just under half of the patients responded that they believed PCI had saved their lives in addition to improving abnormalities seen on their stress test as well as their angina symptoms.
Percentage of Patients Who Believed the Following to Be True
|Procedure was an emergency||33|
|Procedure would help prevent MI||71|
|Procedure would extend life||66|
|Procedure saved their life||42|
|Procedure improved stress test abnormality||42|
|Procedure decreased angina symptoms||31|
In questions addressing the types of therapy that were offered to them, 68% said they were not offered any therapy other than PCI, while 18% recalled being offered medical therapy and even fewer (13%) responded that they had been offered CABG. Lee and colleagues also looked at whether patient responses to the question of treatment options changed after the publication of the COURAGE trial, which showed that treating patients with PCI at the outset had no impact on death or MI different from treating patients with an initial strategy of optimal medical therapy. In fact, following the publication of COURAGE in April 2007, patient responses to the question of whether they'd been offered medical therapy or CABG, rather than PCI, were no different than they were prior to the publication of COURAGE. "It's not so surprising we didn't see differences in patient perceptions, but it is a little surprising that there were no differences in treatments offered," Lee said.
"Better patient education may be needed prior to elective PCIs to elucidate the evidence-based risks and benefits so as to facilitate more truly informed consent," he concluded.
Getting at Patient Perceptions
Commenting on the study for heartwire , Dr Rita Redberg (University of California, San Francisco) said she believed the cardiology community needs to sit up and take notice of these kinds of data.
"Everyone, even the interventionalists, came out after the COURAGE trial and said, 'This is nothing new, we know that PCI doesn't prevent heart attack or make you live longer; we don't do PCI for that reason.' So particularly in the modern era, where this is well-established, to see that most of the patients say that the reason they got their PCI was to prevent a heart attack or live longer and that the clearly elective population still thinks their procedure is an emergency--it certainly raises questions as to what is going on here. We weren't in the room, so maybe patients were told one thing but heard something else--that's always a possibility. But we certainly are not doing well at communication, and for 68% to say that they hadn't been offered any alternative to PCI: that's incredible."
You don't ask the barber whether you need a haircut.
Dr William S Weintraub (Emory University, Atlanta, GA), a co-PI for COURAGE, told heartwire that there are important questions that need to be asked about these data. The first is whether the questionnaire used was valid: do the questions in fact measure what the patients truly believe? "I'm not saying they're not, but we always need be a little wary with anything that's getting at patient perceptions," he said.
The second question is why. "Is it that patients are being misinformed, that the doctors are saying to them, 'You need to have this procedure,' and they're confabulating the rest? Or are they really being misinformed, and doctors are telling them, 'This is a life-saving procedure and if you don't have this you're going to have a heart attack'? We have no idea, but clearly patients are still misinformed at some level. It's pretty scary."
It's also possible that patients, when they're sick, have trouble hearing what they're being told, Weintraub added. "People know they have blockages in their hearts, they're scared, and when you're sick and need these procedures, it's very hard to hear anything. So we need to educate patients, but we need to do it very, very gently."
Redberg also pointed to what she called a wider problem. "We have an entire culture that is like a speeding train heading to the cath lab after someone has been identified as having any kind of chest pain, coronary calcium, or screening tests, even if they are asymptomatic. Once patients are in the cath lab, if they have any disease at all, they end up with a stent. . . . You don't ask the barber whether you need a haircut."
Twenty-five years ago, she said, a diagnostic catheterization was never done in the same setting as the angioplasty. "You had to wake the patient up and have the discussion," she said. Now, she points out, patients speak with the interventionalist prior to the diagnostic cath, but they sign a consent form for catheterization/PCI. The conversation as to what other options there might be, beyond PCI, never takes place.
Lee agreed, but suggested interventionalists don't shoulder all the blame. "Patients really go down a line of physicians when they end up in the cath lab. They start with their primary doctor, who suspects coronary disease, then sends them for a stress test, then they may end up at interventionalist's office for consultation, then on to the cath lab. . . . It’s the responsibility of every single one of those physicians to educate the patients."
Lee and coauthors disclosed having no conflicts of interest
face="Verdana" size="1">The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.
Heartwire from Medscape © 2008 Medscape
Cite this: Shelley Wood. AHA 2008: Patients Believe Elective PCI Prevents MI and Saves Lives, But Who's to Blame? - Medscape - Nov 12, 2008.