Promoting evidence-based medicine

Angioplasty and stenting continue to be used in stable coronary artery disease (i.e. not in the middle of a heart attack), even though a large randomized controlled trial (the COURAGE trial) was the first of several to show that they add no significant survival benefit. Angioplasty and stenting are exceedingly expensive and carry risks (including heart attack and stroke) to the patient.

The data has been a shock to many cardiologists, who see symptomatic relief in many patients and have been performing angioplasties in a good-faith effort to help improve quality of life. It is extremely difficult news to digest psychologically (and financially), and very little proactive help seems to have been offered in this area by professional societies, with the current status in the field seeming to alternate between resistance and denial. Now that this information has become more visible, we hope to see professional societies taking a leadership role in assisting their members to understand the implications for their practice-- always with the patient’s best interest in mind. The two papers by Lin GA et al. below give insight into some of the issues which need to be addressed.

To raise awareness of this issue, Parsemus Foundation supports publication of articles analyzing and discussing peer-reviewed studies on appropriate and inappropriate use of angioplasty and stenting. Our goal is to prevent patients-- each of whom is somebody’s parent or important to somebody-- from facing unnecessary risks and in some cases debilitating medical expenses, without a clear expected benefit. Most patients undergo angioplasty because they believe it may save their life; if that is not the case, then they (and their doctors) deserve to know the full picture.

Where is the famous graphic?

When it seemed that the COURAGE data was producing barely a ripple in prescribing practices, we commissioned an ironic graphic to highlight inappropriate use, a 1950’s-style mock “ad” that highlighted some of the psychological factors that lead to angioplasty even when data do not show benefit; however, it has come to our attention that some cardiologists find it offensive and see it as attacking angioplasty in general, not inappropriate use in stable coronary artery disease.  Since as of July 2011 there is now more public awareness (new published information about results not affecting treatment practice as much as they should which has been covered in major media), and the greatest need now is less for alerting the public to the danger of over-enthusiastic prescribing and more for cardiologists and clinicians to come together to incorporate new guidelines, we have taken the graphic down, figuring the point has now been made in the press and the data can speak for itself.

July 2011 media coverage of the issue:

OAT Trial Had Little Impact on Clinical Practice, Forbes

Doctors overuse heart treatment, despite guidelines, Reuters

Guidelines Don’t Curb Unnecessary Treatment for Heart Attack Patients, Bloomberg

Adherence to Angioplasty/Stent Guidelines Lacking: Study, U.S. News & World Report

Heart Stents Still Overused, Despite Guidelines: Study, Huffington Post

Adherence to Angioplasty/Stent Guidelines Lacking: Study, Doctors Lounge

Earlier coverage:

Stents: How new technology drives health costs. 4/2011, Reuters

A few relevant background studies:

[Note: These studies below were done and published before Parsemus Foundation became involved with

(or even aware of) this issue.]

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N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.

Optimal medical therapy with or without PCI for stable coronary disease.

Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group.

CONCLUSIONS: As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.

PMID: 17387127

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Arch Intern Med. 2007 Aug 13-27;167(15):1604-9.

Cardiologists' use of percutaneous coronary interventions for stable coronary artery disease.

Lin GA, Dudley RA, Redberg RF.

Division of General Internal Medicine, University of California-San Francisco School of Medicine, CA 94143-0124, USA.

BACKGROUND: Percutaneous coronary intervention (PCI) is commonly performed in patients with stable coronary artery disease, despite current evidence suggesting that such patients derive minimal benefit from the procedure. We sought to determine the influences on cardiologists' decision to perform elective PCI in patients with stable coronary artery disease. METHODS: We conducted a qualitative study using 3 focus groups of interventional and noninterventional cardiologists in California. Participants discussed issues surrounding the decision to perform PCI using hypothetical case scenarios. We analyzed the data according to the principles of grounded theory. RESULTS: Despite acknowledging data showing that PCI offers no reduction in the risk of death or myocardial infarction in patients with stable coronary artery disease, cardiologists generally believed that PCI would benefit such patients. Reasons given for performing PCI included belief in the benefits of treating ischemia and the open artery hypothesis, especially with drug-eluting stents; potential regret for not intervening if a cardiac event could be averted; alleviation of patient anxiety; and medicolegal considerations. Participants believed that, in patients undergoing coronary angiography, an "oculostenotic reflex" prevailed and all significant amenable stenoses would receive intervention, even in asymptomatic patients. CONCLUSIONS: The widespread application of PCI in stable coronary artery disease for indications unsupported by evidence may reflect discordance between cardiologists' clinical knowledge and their beliefs about the benefits of PCI. Nonclinical factors appear to have substantial influence on physician decision making. Future studies should focus on the development of methods to help providers more fully incorporate clinical evidence into their medical decision making.

PMID: 17698682

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J Gen Intern Med. 2008 Sep;23(9):1458-63. Epub 2008 Jul 10.

Why physicians favor use of percutaneous coronary intervention to medical therapy: a focus group study.

Lin GA, Dudley RA, Redberg RF.

Division of General Internal Medicine, University of California, San Francisco 94143, USA.

BACKGROUND: Percutaneous coronary intervention (PCI) is performed in many patients with stable coronary artery disease, despite evidence of little clinical benefit over optimal medical therapy. OBJECTIVE: To examine physicians' beliefs, practices, and decision-making regarding elective PCI. DESIGN: Six focus groups, three with primary care physicians and three with cardiologists. Participants discussed PCI using hypothetical case scenarios. Transcripts were analyzed using grounded theory, and commonly expressed themes regarding the decision-making pathway to PCI were identified. PARTICIPANTS: Twenty-eight primary care physicians and 20 interventional and non-interventional cardiologists in Butte County, Orange County, and San Francisco Bay Area, California, in 2006. RESULTS: A number of factors led primary care physicians to evaluate non-symptomatic or minimally symptomatic patients for coronary artery disease and refer them to a cardiologist. The use of screening tests often led to additional testing and referral, as well as fear of missing a coronary stenosis, perceived patient expectations, and medicolegal concerns. The end result was a cascade such that any positive test would generally lead to the catheterization lab, where an "oculostenotic reflex" made PCI a virtual certainty. CONCLUSIONS: The widespread use of PCI in patients with stable coronary artery disease--despite evidence of little benefit in outcomes over medical therapy--may in part be due to psychological and emotional factors leading to a cascade effect wherein testing leads inevitably to PCI. Determining how to help physicians better incorporate evidence-based medicine into decision-making has important implications for patient outcomes and the optimal use of new technologies.

PMID: 18618192

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JAMA. 2008 Oct 15;300(15):1765-73.

Frequency of stress testing to document ischemia prior to elective percutaneous coronary intervention.

Lin GA, Dudley RA, Lucas FL, Malenka DJ, Vittinghoff E, Redberg RF.

Division of General Internal Medicine, University of California, San Francisco, USA.

CONTEXT: Guidelines call for documenting ischemia in patients with stable coronary artery disease prior to elective percutaneous coronary intervention (PCI). OBJECTIVE: To determine the frequency and predictors of stress testing prior to elective PCI in a Medicare population. DESIGN, SETTING, AND PATIENTS: Retrospective, observational cohort study using claims data from a 20% random sample of 2004 Medicare fee-for-service beneficiaries aged 65 years or older who had an elective PCI (N = 23 887). MAIN OUTCOME MEASURES: Percentage of patients who underwent stress testing within 90 days prior to elective PCI; variation in stress testing prior to PCI across 306 hospital referral regions; patient, physician, and hospital characteristics that predicted the appropriate use of stress testing prior to elective PCI. RESULTS: In the United States, 44.5% (n = 10 629) of patients underwent stress testing within the 90 days prior to elective PCI. There was wide regional variation among the hospital referral regions with stress test rates ranging from 22.1% to 70.6% (national mean, 44.5%; interquartile range, 39.0%-50.9%). Female sex (adjusted odds ratio [AOR], 0.91; 95% confidence interval [CI], 0.86-0.97), age of 85 years or older (AOR, 0.83; 95% CI, 0.72-0.95), a history of congestive heart failure (AOR, 0.85; 95% CI, 0.79-0.92), and prior cardiac catheterization (AOR, 0.45; 95% CI, 0.38-0.54) were associated with a decreased likelihood of prior stress testing. A history of chest pain (AOR, 1.28; 95% CI, 1.09-1.54) and black race (AOR, 1.26; 95% CI, 1.09-1.46) increased the likelihood of stress testing prior to PCI. Patients treated by physicians performing 150 or more PCIs per year were less likely to have stress testing prior to PCI (AOR, 0.84; 95% CI, 0.77-0.93). No hospital characteristics were associated with receipt of stress testing. CONCLUSION: The majority of Medicare patients with stable coronary artery disease do not have documentation of ischemia by noninvasive testing prior to elective PCI.

PMID: 18854538

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Am Heart J. 2009 Apr;157(4):695-701.

Persistent reservations against contradicted percutaneous coronary intervention indications: citation content analysis.

Siontis GC, Tatsioni A, Katritsis DG, Ioannidis JP.

Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Greece.

BACKGROUND: Two large trials, Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) and Occluded Artery Trial (OAT), found no benefits of percutaneous coronary intervention (PCI) versus optimal medical therapy in chronic stable coronary artery disease and chronic total occlusion. METHODS: We examined the stance of articles citing COURAGE and OAT to determine whether some authors continue to defend PCI despite this evidence, what persisting counterarguments are raised to express reservations, and whether specific characteristics of the citations are associated with reservations. We evaluated all citing articles entered in the Web of Science until February 1, 2008. Specific characteristics were recorded for each eligible citation, and a citation content analysis was performed. Counterarguments were categorized on participants, interventions, comparisons, and outcomes. RESULTS: Of 54 articles citing COURAGE and 33 articles citing OAT, 10 (19%) and 5 (15%), respectively, had an overall reserved stance. Alluded reservations included lack of power, eroded effects from crossover, selective inclusion and exclusion of specific types of patients, suboptimal clinical setting, use of bare-metal stents, suspiciously good results in the conservative treatment arm, and suboptimal outcome choices or definitions. Reserved articles were more likely than unreserved ones to have an interventional cardiologist as corresponding author (odds ratio 5.2, 95% confidence interval 1.6-17.1; P = .007) and to be commentaries focusing on one of these trials (odds ratio 3.3, 95% confidence interval 1.0-11.0; P = .05). CONCLUSIONS: Despite strong randomized evidence, a fraction of the literature, mostly corresponded by interventional cardiologists, continues to raise reservations about recently contradicted indications of PCI.

PMID: 19332198