Abstract
Objective
Although percutaneous coronary intervention (PCI) reduces mortality in the setting of myocardial infarction (MI), recent studies suggest that the benefits of PCI for chronic Coronary Artery Disease (CAD) are predominantly related to angina relief and improved quality of life. Whether patients in the current era understand these benefits of elective PCI, or perceive that they also derive protection against death and MI is unknown.
Patients & Methods
We surveyed 498 consecutive elective PCI patients a mean of 13.7 months after being treated between 1/06 – 10/07, 2007, at two hospitals. We used a one-page questionnaire quantifying their perceptions of the benefits from PCI.
Results
Of 498 eligible subjects, 350 responded (70%). The mean age was 67.8 ± 10.9 years, and 76% were male. One-third believed that their PCI was emergent (despite the fact that all were elective), 71% believed the procedure would prevent future heart attacks, 66% thought it would extend their life, 42% reported that it saved their life, 42% stated that it would improve abnormalities on their stress test, and only 31% believed it would decrease their angina.
Conclusion
Although considerable attention is given to facilitating informed consent at our center, patients’ perceived benefits of elective PCI do not match existing evidence, as they overestimated both the benefits and urgency of their procedures. These findings suggest that an even greater effort at patient education is needed prior to elective PCI to facilitate fully informed decision-making.
Introduction
The Institute of Medicine has urged physicians to transparently share the evidence regarding potential risks and benefits of treatments being offered to patients so that they can make fully informed decisions that are aligned with the patients’ personal goals and values.1 Although physicians typically review the different treatment options, as well as the risks and benefits of therapy, this discussion may not be fully understood by patients.2
In the case of PCI for stable CAD, the major benefits of this procedure are angina relief and improved quality of life.3–6 In particular, PCI for stable CAD has not been shown to prevent death or MI. While these concepts are well known by clinicians and embedded in clinical guidelines,7 it is uncertain whether patients’ understanding of these facts has increased since it was reported that patients’ overestimated the benefits of elective PCI a decade ago.8
The purpose of this study was to examine whether patients’ perceptions of the benefits from elective PCI are aligned with current evidence. We also sought to assess patients’ recall of the treatment alternatives they were offered given that surgical revascularization and noninvasive medical options also exist for the treatment of stable coronary disease. Finding a gap between patients’ perspectives of the benefits of PCI and current evidence can highlight the need to develop novel strategies to better inform the discussion of treatment options in CAD.
Methods
Patient Population and Study Design
Approval for the study was obtained from the institutional review board of Saint Luke’s Hospital in Kansas City, Mo. We designed a survey (See Appendix A) to assess patients’ perceptions about the benefits of elective PCI and to assess their recall of the treatment alternatives offered at the time of informed consent. Using the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR) at our site, we identified 500 consecutive patients who underwent PCI for stable CAD between January 2006 and October 2007. Eligible patients included those referred to left heart catheterization for stable angina, atypical chest pain or no symptoms, such as those with significant ischemia on non-invasive testing. Patients were excluded if they presented with an acute coronary syndrome, including ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), or unstable angina. Eligible patients were then sent a letter of explanation in January 2008, regarding the study and a request to complete and return the one-page questionnaire in a stamped, pre-addressed envelope. Six weeks after the initial mailing, questionnaires were resent to non-responders. Other than the clinical indications for the procedure, all other information used for this study was obtained from the one-page survey, including self-reported demographic and cardiovascular risk factors.
Statistical Analysis
Over a four-month period following distribution of the questionnaires, patient responses were collected, entered into a database, converted into proportions, and analyzed. Due to the descriptive analysis of this study, only bivariate t-tests and Chi-square tests were performed. A p-value < 0.05 was considered statistically significant and all analyses were conducted with SAS version 9.1.
The sample size for this study was estimated with the predicted maximum acceptable confidence interval widths for the various survey question responses. Our target sample size of 500 patients assumed a survey completion rate of 80% and 400 completed surveys. With this sample size, the maximum confidence interval half-width (at a hypothetical survey question response percentage of 50%) is 5%, which was judged to be an acceptable level of uncertainty. If only 60% of patients were to respond, the confidence interval would be 5.7% which was also felt to be a clinically reasonable estimate of patients’ assessment of the benefits of PCI.
Results
A total of 498 eligible subjects were identified and sent the study materials. Of these, 350 (70.3%) returned completed questionnaires. While gender was similar between respondents and non-respondents (76% vs. 77% male, p=0.75), respondents were slightly older (67.8 ± 10.9 vs. 63.0 ± 11.5 years; p < 0.001). The mean time from subjects’ PCI to the questionnaire being completed was 13.4 ± 7.2 months.
Analysis of Patients’ Perceived Benefits of Elective PCI
Figure 1 provides an overview of the primary findings. One-third of these elective patients believed that their PCI was emergent. Moreover, 42% believed that their PCI saved their life, and 70% reported that the PCI would prevent future heart attacks. Two-thirds believed the PCI procedure would extend their lives and 42% stated that the PCI would improve an abnormality noted on their stress test. Importantly, only 31% felt that PCI would decrease their anginal symptoms.
Figure 1.
Patient perceived benefits of elective PCI.
Analysis of Recollected Treatment Alternatives Offered
When asked whether additional treatment options had been offered, 18% recalled that medical therapy was offered as an alternative to PCI, and 14% recalled that bypass surgery was as an option. More than two-thirds of patients (68%) reported that they could not recall being offered any alternate therapy, other than PCI.
Changes in Perceptions Before and After COURAGE Trial
A post-hoc analysis of the current survey showed that the there were no significant differences in the perceived benefits of PCI among the patients who underwent their procedure before (n= 253) or after (n=245) the publication of the COURAGE trial, in April, 2007 (See Figure 2).
Figure 2.
Pre- and post-COURAGE perceived benefits of elective PCI.
Discussion
Aggressive medical therapy (including secondary prevention with statins, aspirin, angiotensin converting enzyme inhibitors, smoking cessation, exercise, and diet has been consistently shown to improve prognosis in patients with stable CAD. Conversely, while PCI is known to improve symptoms, it has never been demonstrated to improve survival more than medical therapy alone.7 We found that, in the current era, patients who undergo elective PCI are much more likely to recall that the procedure was performed to improve their survival, or to prevent a heart attack, than to improve their symptoms. Specifically, the majority of patients believed that the procedure would reduce their risk of death and MI, while less than a third of patients understood that angina relief (the one outcome for which unequivocal evidence of benefit exists) was a primary treatment goal.5,6 Moreover, despite a systematic and sophisticated process of obtaining informed consent process at our institution,9 the majority of patients could not recall discussing alternative treatment options with their physicians. These findings demonstrate a discrepancy between available evidence and patients’ perceptions of treatment benefits and highlight the need for better strategies to more accurately educate and inform patients.
Our findings are quite similar to those of Holmboe and colleagues, who conducted a similar study almost a decade ago.8 In that study, they demonstrated that 75% of the patients undergoing elective PCI believed that the procedure would prevent a future heart attack, while 71% believed that it would prolong their life. This preconception may be particularly difficult to overcome due to the somewhat counterintuitive “disconnect” between the presence of an angiographic stenosis and the future risk of MI.
The COURAGE trial,6 and several smaller studies 3–5,10,11 have established that the benefits of elective PCI relate predominantly to improvements in angina (or related symptoms) and amelioration of abnormalities noted on pre-PCI stress testing.12 Furthermore, because there are no reported prognostic differences between PCI and medical therapy in the elective setting, patients should be aware that, in the absence of high-risk findings on myocardial perfusion imaging, either PCI or medical therapy is a reasonable initial option. Whether the discrepancy between established evidence and patient understanding of PCI benefits found in this study is due to inadequate informed consent discussions, patient’s inability or unwillingness to understand the complexities of medical decision making, or poor recollection of informed consent discussions requires further study, particularly if physicians hope to fulfill the IOM call to better engage patients in their own healthcare decision making.
We believe that while this study occurred at a single center and generalizing to other centers may be problematic, it is important to appreciate that our institution goes to great lengths to assure that patients are fully informed regarding risks and benefits before they give consent for a PCI. For example, we use a customized consent tool, PREDICT, to provide individualized estimates of patients’ outcomes based upon the multivariable, risk-adjustment models developed by the ACC-NCDR.9 Despite these efforts to provide the highest quality informed consents, we observed substantial misunderstanding about the potential benefits of treatment. Thus the comprehension of treatment benefits at other centers may be even worse than those observed in this study, as has recently been reported at an institution in Massachusetts.13 It is also possible that obtaining informed consent immediately prior to cardiac catheterization and PCI is not the proper time in the flow of care for patients with stable CAD to be taught about the risks, benefits and alternatives to PCI. Importantly, we feel that the informed consent process, as well as the education of patients, should not rest solely on the shoulders of the interventional cardiologists and should be shared with referring physicians, who chronically manage the patient and have the opportunity to better explain the benefits and options for treating their stable coronary disease. Most likely patients will need to discuss their treatment options at several points during their care to successfully align their perceptions of risks and benefits of elective PCI with the currently available evidence.
One possible approach to improving doctor patient communication might be to administer a subset of the questions used in our survey (See Appendix B) to patients prior to PCI to screen for misconceptions about the goals and benefits of their procedure. Patients who do not understand the goals of therapy could then be offered additional education prior to their procedure so that their expectations can be more aligned with available evidence.
The findings of this study should be interpreted in light of several potential limitations. First, our study depends on patients’ recall of their understanding of the benefits or a procedure that occurred many months (mean of 13 months) before our survey. In accordance with our routine pre-PCI protocol, treating physicians very likely elucidated all the treatment benefits and risks as well as all of the alternate therapies available to each patient. Yet, in retrospect, these details were forgotten or misconstrued, highlighting the need for a more thorough educational process. Second, this study was conducted in a single hospital system and our findings may not be generalizable to other practices and patient populations. We use individualized, patient-centered, informed consent documents that have been shown to increase the likelihood that patients read our consent forms and enhance patients’ perceptions of their participation in the medical decision-making process.14 While these consent forms do not emphasize that the primary goals of treatment are symptom relief, this study suggests that further refinement of the informed consent process is needed. An additional potential limitation of this study is that we did not have access to patients’ pre-procedural stress test results. Hachomovitch and colleagues have shown that patients with ischemia involving > 10% of the left ventricular mass by myocardial perfusion imaging may be better treated with PCI, as opposed to medical management, and this may have influenced the indication for PCI.15 Importantly, though, less than 5% of Hachomovitch’s population had such high-risk ischemia and it is unlikely that this could have had a major impact on our findings.15 In addition, we had a 30% nonresponse rate and we cannot exclude a selection bias that might alter the exact estimates of our findings, although a strong association between understanding the benefits of treatment and not participating in our survey would be needed to confound our observations. Moreover, even if such a bias did exist, the marked disparity between respondents’ perceptions and clinical evidence supporting the use of PCI in the 70% of those who responded still indicates an important opportunity to improve the educational process surrounding the benefits of PCI.
Even physicians may continue to overestimate the potential benefits of PCI as demonstrated by a recently published study by Borden and colleagues that looked at the patterns of medical therapy before and after the COURAGE study was published. This observational study found that currently on 45% of patients undergoing PCI are receiving optimal medical therapy, which is unchanged from the pre-COURAGE era.
Even physicians may continue to overestimate the potential benefits of PCI as demonstrated by a recently published study by Borden and colleagues that looked at the patterns of medical therapy before and after the COURAGE study was published. This observational study found that currently only 45% patients undergoing PCI are receiving optimal medical therapy, which is unchanged from the pre-COURAGE era.16 Another prospective large randomized study, the STICH trial, recently provided further evidence of the power of optimal medical therapy to improve prognosis in coronary disease.17 In this trial optimal medical therapy was non-inferior to coronary artery bypass graft surgery for improving long term prognosis for patients with multivessel coronary disease and left ventricular dysfunction.
Conclusion
In a single healthcare system, we found that patients’ perceived benefits of elective PCI do not match existing evidence. In particular, patients overestimated both the benefits and urgency of their procedures. These findings suggest that greater efforts in patient education are needed prior to elective PCI so as to facilitate fully informed decision-making.
Acknowledgments
The authors wish to thank Lori J. Wilson for her instrumental role in conducting this study as well as preparation of this manuscript. Permission has been obtained for acknowledgment.
Biography
John H. Lee, MD, is at the John Ochsner Heart & Vascular Institute, Ochsner Clinical School, The University of Queensland School of Medicine, New Orleans. Kenny Chuu, MD, John Spertus, MD, MSMA member since 2003, David J. Cohen, MD, MSMA member since 2004, James A. Grantham, MD, MSMA member since 2004, Fengming Tang, MS, and Corresponding Author James H. O’Keefe, MD, (above) MSMA member since 2008, are at Saint Luke’s Health System’s Mid America Heart & Vascular Institute and University of Missouri-Kansas City, Kansas City, MO.
Presented at the November 2008 Annual Scientific Sessions of the American Heart Association.
Contact: jokeefe@saint-lukes.org.
Appendix A. PCI Questionnaire
Appendix B. Potential questionnaire to be used prior to elective PCI to assess patient understanding of the procedure
Footnotes
Presented at the November 2008 Annual Scientific Sessions of the American Heart Association.
Disclosures
Disclosures: None: JHL, KC, JS, JAG, FT, JHO; DJC: Research grant support from Boston Scientific and Abbott Vascular. Consulting fees from Cordis, Medtronic and St. Jude Medical.
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