PCI for stable angina: A missed opportunity for shared decision-making
ABSTRACT
Percutaneous coronary intervention (PCI) continues to be frequently performed for patients with stable coronary artery disease, despite clear evidence that it provides minimal benefit over optimal medical therapy and entails small but not inconsequential risks. Many patients and doctors do not fully understand the risks and benefits of PCI, even when presented with the evidence, and this makes informed consent challenging. The best approach is shared decision-making, with doctor and patient together choosing the best treatment option after considering the evidence and the patient’s preferences.
KEY POINTS
- For patients with stable angina pectoris, PCI does not prevent myocardial infarction or death.
- Optimal medical therapy with aspirin and a statin can reduce the risk of myocardial infarction and should be recommended for all patients with stable angina, regardless of whether they undergo PCI.
- PCI improves symptoms of angina faster than medical therapy alone, but more than half of patients will be free of angina in about 2 years with either option.
- In the absence of information to the contrary, most patients and some doctors assume that PCI is life-saving and are biased towards choosing it. As a result, patients are rarely able to give true informed consent to undergo PCI.
Cardiologists’ reasons for performing PCI
If PCI cannot improve hard outcomes like MI or death in stable coronary disease, why do cardiologists continue to perform it so frequently?
Soon after the COURAGE trial, Lin et al conducted focus groups with cardiologists to find out.20 Some said that they doubted the clinical trial evidence, given the reduction in the cardiac mortality rate over the past 30 years. Others remarked that their overriding goal is to stamp out ischemia, and that once a lesion is found by catheterization, one must proceed with PCI. This has been termed the “oculostenotic reflex,” ie, the interventionist sees coronary artery disease and immediately places a stent.
Atreya et al found objective evidence of this practice.21 In a 2016 study of 207 patients with obstructive lesions amenable to PCI, the only factors associated with medical management were those that increased the risk of the procedure: age, chronic kidney disease, distal location of the lesion, and type C lesions (the most difficult ones to treat by PCI). More important, evidence of ischemia, presence of angina, and being on optimal medical therapy or maximal antianginal therapy were not associated with PCI.
When surveyed, cardiologists offered reasons similar to those identified by Lin et al, including a positive stress test (70%) and significant myocardium at risk (50%).18 Optimal medical therapy failure was cited less often (40%). Over 30% identified relief of chest pain for patients who were not prescribed optimal medical therapy. Another 30% said that patient anxiety contributed to their decision, but patients who reported anxiety were not more likely to get PCI than those who did not.
True informed consent rarely occurs
Surveys of patients and recordings of doctor visits suggest that doctors often discuss the risks of the procedure but rarely accurately describe the benefits or mention alternative treatments, including optimal medical therapy.
Fowler et al22 surveyed 472 Medicare patients who had undergone PCI in the past year about their consent discussion, particularly regarding alternative options. Only 6% of patients recalled discussing medication as a serious option with their doctor.
In 2 published studies,23,24 we analyzed recorded conversations between doctors and patients in which angiography and PCI were discussed.
In a qualitative assessment of how cardiologists presented the rationale for PCI to patients,23 we observed that cardiologists gave an accurate presentation of the benefits in only 5% of cases. In 13% of the conversations the benefits were explicitly overstated (eg, “If you don’t do it [angiogram/PCI], what could happen? Well, you could…have a heart attack involving that area which can lead to a sudden death”). In another 35% of cases, physicians offered an implicit overstatement of the benefit by saying they could “fix” the problem (eg, “So that’s where we start thinking, Well maybe we better try to fix that [blockage]”), without specifically stating that fixing the problem would offer any benefit. Patients were left to fill in the blanks. Conversations frequently focused on the rationale for performing PCI (eg, ischemia on a stress test) and a description of the procedure, rather than on the risks and benefits.
In a quantitative study of the same data set, we assessed how often physicians addressed the 7 elements of informed decision-making as defined by Braddock et al.24
- Explaining the patient’s role in decision-making (ie, that the patient has a choice to make) was present in half of the conversations. Sometimes a doctor would simply say, “The next step is to perform catheterization.”
- Discussion of clinical issues (eg, having a blockage, stress test results) was performed in almost every case, demonstrating physicians’ comfort with that element.
- Discussing treatment alternatives occurred in only 1 in 4 conversations. This was more frequent than previously reported, and appeared most often when patients expressed hesitancy about proceeding to PCI.
- Discussing pros and cons of the alternatives was done in 42%.
- Uncertainty about the procedure (eg, that it might not relieve the angina) was expressed in only 10% of conversations.
- Assessment of patient understanding was done in 65% of cases. This included even minimal efforts (eg, “Do you have any questions?”). More advanced methods such as teach-back were never used.
- Exploration of patient preferences (eg, asking patients which treatment they prefer, or attempting to understand how angina affects a patient’s life) the final element, occurred in 73% of conversations.
Only 3% of the conversations contained all 7 elements. Even using a more relaxed definition of 3 critical elements (ie, discussing clinical issues, treatment alternatives, and pros and cons), only 13% of conversations included them all.
Discussion affects decisions
Informed decision-making is not only important because of its ethical implications. Offering patients more information was associated with their choosing not to have PCI. The probability of a patient undergoing PCI was negatively associated with 3 specific elements of informed decision-making. Patients were less likely to choose PCI if the patient’s role in decision-making was discussed (61% vs 86% chose PCI, P < .03); if alternatives were discussed (31% vs 89% chose PCI, P < .01); and if uncertainties were discussed (17% vs 80% chose PCI, P < .01).
There was also a linear relationship between the total number of elements discussed and the probability of choosing PCI: it ranged from 100% of patients choosing PCI when just 1 element was present to 3% of patients choosing PCI when all 7 elements were present. The relationship is not entirely causal, since doctors were more likely to talk about alternatives and risks if patients hesitated and raised questions. Cautious patients received more information.
From these observational studies, we know that physicians do not generally communicate the benefits of PCI, and patients make incorrect assumptions about the benefits they can expect. We know that those who receive more information are less likely to choose PCI, but what would happen if patients were randomly assigned to receive complete information?