New Orleans, LA - 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.
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Dr John Lee
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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
Patient beliefs
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%
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Procedure was an emergency
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33
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Procedure would help prevent MI
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71
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Procedure would extend life
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66
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Procedure saved their life
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42
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Procedure improved stress test abnormality
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42
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Procedure decreased angina symptoms
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31
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To download table as a slide, click on slide logo above
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
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Dr Rita Redberg
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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 emergencyit 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 elsethat'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
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November 12, 2008 07:39 (EST)
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whoa there! Maybe the patients are better informed than some physicians
with the recent meta-analysis of Kastati,the recent Japanese randomized PCI vs Medical study both benefit in death,or MI and urgent hospitalixzations,compounded by equivalent death and Mi rates in PCI and CABG seen in SYNTAX there are clearly patients who do benefit.COURAGE demonstrated that all patients do not.PCI is superior with moderate or severe ischemia and certainly superior for symptom relief. |
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November 12, 2008 10:07 (EST)
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meta-analysis raises questions but does not give answers The question raised by a meta-analysis needs to be validated with a prospective study. The only 2 prospective studies on stenting vs medical management (Courage and Rita II) demonstrated no reduction in infarction or death from stenting.
The perceived value of stenting is far greater that the real value thus the insanity of stenting that occurs in this country. |
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November 12, 2008 11:45 (EST)
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Informed Consent, and patient understanding of the procedure First, It's good to see Dr. Moses on theheart.org. I would like to elaborate a bit on Dr. Moses's comments (he can shoot me later)!
In the last couple of days, I performed a diagnostic cath on two patients who had clear cut stable angina with markedly positive stress tests. Despite the data that Dr. Moses cited above, I spent the better part of two hours with each patient (and their families), explaining the risks and benefits of revascularization in the setting of stable angina, prior to the catheterization, with an emphasis on relieving symptoms (not reducing MI or death, which may be the case in higher risk patients). I specifically brought up the conclusion of the courage investigators, and explained that if I were to treat their CAD, it would be to relieve symptoms only, much like an anesthesiologist, and not to reduce their underlying problem, which would need to be treated with lifestyle changes and medications. Despite this, both patients and their families chose PCI and both requested drug eluting stents. They both stated that they were unhappy with being limited to walking 25-50 feet before they had to stop and needed a better way to live.
What patients understand and believe after a detailed explanation, I leave to the paper below. But presented with the facts in the most detailed way imaginable, perhaps it is that patients with stable angina with significant symptoms do not find the question of MI/death as relevant as their desire to feel normal again. |
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November 13, 2008 09:13 (EST)
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A common sense approach Anuj,
In the patients that you describe, a PCI may well be life saving, and could only be proven with very long term studies. We don't study much of anything but Framingham for more than 3-5 years. If your patients listed above become sedentary , overweight, depressed, have significant glucose intolerance, there is no doubt in the realm of common sense that these developments would compromise their longevity. Therefore, we must go beyond what a 4 year study can tell us in some instances.
Melissa |
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November 13, 2008 11:12 (EST)
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listen to the Informed patient Dear Melissa
I fully agree with you and the common sense that guides Anuj. This tells us one more time that we should use studies results and guidelines to assist us in optimizing the treatment and providing valuable information to the patients, but we should never forget to LISTEN to them and provide them the optimal most suitable treatment after enlightening them about pro and cons.
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November 13, 2008 12:32 (EST)
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but who's to blame? Clearly the interventionalists.
Dr. Ihab Suliman |
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November 13, 2008 06:54 (EST)
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COURAGE is clear The Courage data is clear: If your elective PCI outcome success rate is only approx. 90%, then allcomers do approx. the same. Subsets of higher success rates, nonVA U.S. patients,crossovers (30% of patients), and patients with heavy ischemic burdens may do better, with more angina relieved with PCI. Do patients know this? |
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November 16, 2008 09:18 (EST)
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good job yes anuj your clear discussion with the patient is great and is what needs to be done.Both the physician and patient should be clear about the PCI indication.Where I would depart from you is saying that we ONLY relieve symptoms.The patients you described pretty much constituted the crossovers anyway,so you saved an inevitable second visit.The bottom 2/3 of the courage group had less than an episode a week at baseline.Your patients should be treated ad hoc as you did.But remember the net benefit of OMT on ischemia was ZERO at 1 year,and that's with 16% PCI crossovers counted.The PCI strategy for patients with significant ischemia saves lives.We are not treating oteoarthritis. |
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November 25, 2008 07:36 (EST)
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risk stratification I agree that we should have informed discussions with out patients. We should also remember to integrate decades of research rather than focus on the last paper we read. Revascularization for high risk ischemia saves lives. As clinicians we need to integrate the patient's lifestyle, non-invasive risk stratification data, and invasive data and provide reasonable options based on the above. |
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December 2, 2008 08:16 (EST)
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% myocardium ischemic Remember the article by Hachmanovitch looking at percent myocardium ischemic and benefit of revascularization. Not every small mild septal defect needs a stent, BUT remember to properly interpret the COURAGE trial where EVERY patient underwent cardiac cath AND there is the problem of patients who crossed over to revascularization, thus clouding the final conclusions drawn by many.
I agree there is a place for medical therapy, but if I have a 90% proximal LAD lesion and angina, give me a stent and I will take my ASA and plavix.
I discuss what the treatment options are with patients BEFORE i send them for cardiac cath. If, based on non-invasive imaging I don't think there is a benefit of cath (single small size, mild severity ischemic defect) I will not send them for cath and explain to them that we will try medical therapy first. Rarely, with a thorough explanation due I get patients who demand to be cath'd.
Just my two cents.
Daniel |
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December 2, 2008 09:48 (EST)
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agree Daniel,
Good point. I agree with your common sense approach. A very proximal LAD lesion always gets an intervention from me.
Melissa |
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December 9, 2008 10:44 (EST)
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Patients believe.....who's to blame? Patients believe that:
Normal cholesterol means no risk for CAD.
Normal HS-CRP means no risk for CAD.
Being thin and exercise prevents all heart attacks.
Treating LDL to 100 prevents all heart attacks.
Blood pressure of 135/85 is OK.
Nuclear stress testing predicts most heart attacks.
Nuclear stress testing does not expose the patient to much radiation.
There is a lot of bad DATA out there. PCI misinformation may be the least of the problems. |
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December 10, 2008 08:36 (EST)
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Agree , we need to do better! Agree William:
To combat that I ALWAYS educate patients regarding how to interpret a stress exam. I always tell them that a NORMAL exam is generally unhelpful for prevention purposes.
It's up to us! We are on the forefront for the delivery of that information!
Melissa |
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December 10, 2008 11:51 (EST)
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"normal" is NOT normal Another area that is misinformed is that your cardiac cath is "normal". We all know about compensatory remodeling demonstrated so eloquently by Glagov's hypothesis some 20-30 years ago. That 40% plaque to begin encroachment on luminal diameter seen on angio. I always use the hole and donut analogy for my patients. "Your cath did not show any significant narrowing requiring an intervention, but we still have to aggressively treat your risk factors..." |
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December 10, 2008 09:08 (EST)
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good job Good point Dan,
Describing a cath as "normal" would be like investigating a crime scene and just looking in the middle of the room without opening the closets!
Keep up the good work!
Melissa |
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