Stents vs. bypass surgery vs. TRUST

by Carolyn Thomas     ♥    @HeartSisters

In 2018, Dr. Dhruv Khullar warned his colleagues at an American Board of Internal Medicine conference that patients need answers on three dimensions of trust:

1. Competence: “Do you know what you’re doing?”
2. Transparency: “Will you tell me what you’re doing?”
3. Motive: “Are you doing this to help me or yourself?”        .     .
   

He told his Rebuilding Trust forum audience that failure to openly answer those questions can affect public trust – both trust in individual physicians and throughout the medical profession. 

This week, our trust was tested when a BBC NightNews investigation made worldwide headlines like this: “Heart Doctors ‘Held Back Stent Death Data’ “.

Others far above my own pay grade have already dissected this BBC report about a cardiology study called the EXCEL trial(1) whose findings were published in the New England Journal of Medicine. For me, it’s not what the headlines were saying that worried me, but the more important issue simmering beneath: how cardiac research is done is affecting patient trust.

Basically, you have dueling heart specialists who are engaged in a very public pissing contest over how best to treat heart patients diagnosed with blockages in the left main coronary artery: stents or open heart bypass surgery?

IN ONE CORNER of this cage fight are the interventional cardiologists (the ones who implant our coronary stents). The EXCEL study was funded by Abbott, a medical device and pharmaceutical company that manufactures the Xience stents used in this study (the world’s best selling stent). And, despite the BBC investigation that found left main patients  in the EXCEL trial who had received stents had 80% more heart attacks than those who had open heart surgery, the published study in the NEJM didn’t say that.

Instead, it suggested that stents were just as safe as open heart surgery in treating patients with left main coronary artery blockages.

Dr. Lars Wallentin, a senior professor of cardiology and founder of the Uppsala Clinical Research Centre in Sweden, was also the head of the study’s safety committee. The BBC report included a copy of his warning email to the EXCEL research team in 2017 (an email that was ignored):

     “It might be very concerning if in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community.”

IN THE OTHER CORNER:   the cardiac surgeons (the ones who do coronary artery bypass graft surgery, which has until recently been the recommended approach to treat heart patients diagnosed with left main coronary artery disease). They view the controversial EXCEL trial results as inaccurate. Dr. David Taggart, a cardiothoracic surgeon at the University of Oxford, was one of the original authors of the EXCEL study, but because of his own personal concerns about the research, withdrew his name from the New England Journal of Medicine paper.

His European surgical colleagues have also issued an official statement following this week’s BBC report, demanding an independent review of EXCEL findings, and confirming their objections to the new stent-friendly left main treatment guidelines that were partly based on EXCEL.

The BBC NightNews report also quoted Dr. John Ioannadis, a Professor of Medicine at Stanford University and an expert on medical research design, who bluntly explained the problems with doctors taking money from the industry whose products they’re studying:

”    All the main doctors working on this EXCEL trial, and the lead doctor writing the guidelines for left main disease, have declared financial contributions to either themselves or their institutions from companies that manufacture stents.

“You have the same people who run the show at all levels. They design the trials. They set the agenda, they choose what to present. They are involved in disseminating the information and running the large conferences that are attended by tens of thousands of people, specialists in the field.

“And then they also populate the guideline panels that reach the recommendations.”

Those observations nicely sum up what so many physicians don’t seem to get. Once you take money from the drug or device industry, no matter how noble you insist your own pristine motives are, whatever you publicly claim about that industry’s products or treatments becomes suspect. As we used to say in my 30+ year public relations career, this is a clear issue of optics:  perception IS reality in the court of public opinion.

In other professional fields, for example, judges are not allowed to take money from defense attorneys. Sports referees are not allowed to take money from team owners. To allow these kinds of financial conflicts of interest would be to cast doubt on the trustworthiness of each expert decision.

So why do physicians believe themselves to be somehow above such basic societal expectations?

One cardiologist blithely confirmed on Twitter: “We all do it!” – a patently wrong-headed attempt at justifying behaviour, as anybody who’s ever been a parent can attest.

And in a remarkably candid statement, Dr. Fiona Godlee, editor-in-chief of the British Medical Journal (BMJ) since 2005, claimed that the New England Journal of Medicine had “not done a good job” by publishing the EXCEL results, and should have put the trial under closer scrutiny.

She further added that, while BMJ was “very, very choosy” about what papers it published, it had not “solved the problem” of biased data being published – a problem she said has been going on “for years” and one that is “getting worse, not better”. She explained:

“   Patients are right to be skeptical about clinical trials – ones that are funded by industry, and that have principal trial investigators funded by industry. We need to have more independent research.”

Both cardiac surgeons and interventional cardiologists earn their paycheques by doing what they are trained to do best. And as Upton Sinclair once explained back in 1934:

“ You can’t get a man to understand something when his salary depends on not understanding it.”

Not surprisingly, responses to the BBC NightNews investigation fall distinctly along that professional divide: interventional cardiologists are generally on one side in support of the EXCEL findings, while surgeons generally support calls for an independent investigation of EXCEL.

So what does this mean to the average heart patient with left main coronary artery disease?

Many of the physicians surveyed on this important question in Cardiology News this week echoed a belief (or a hope?) that shared decision-making among physicians and their patients will simply continue on as before.

As one interventional cardiologist explained, his message to patients will still be that patients with left main blockages are more likely to require repeat interventions if they have a stent implanted compared to bypass surgery, “but to get the benefits of surgery, you have to have the operation, and not all patients are keen on this. In the end, it is the patient who decides what treatment they will submit to, not the doctor.”

Or is it?

What happens when people begin to lose trust in those they have always considered to be “the experts”? 

First of all, it’s not my role as a heart patient to come up with ways to slow an erosion of trust, but I’m concerned when I observe how what doctors do (or don’t do) hasten that erosion.

We want and need to trust our physicians.

Dr. Bob Wachter is chairman of the Department of Medicine at the University of California San Francisco; in 2018, like Dr. Khullar, he too spoke to his colleagues at the American Board of Internal Medicine’s Rebuilding Trust forum.

They examined the importance of trust, and strategies for building trust across a range of health care relationships, including public trust in the medical system as a whole. He summarized a set of conditions that can affect the public’s trust in medicine, including:

• a growing volume of competing and contradictory sources
• treatment recommendations that change over time
• over-hyped research findings
• financial conflicts of interest
• perceptions among the public that medicine is just a business
• the quality and safety movements that highlighted medicine’s defects
• clumsy efforts to restrain health care costs
• an increasingly diverse society
• tribalism in politics

He also suggested that our feelings about trust generally are “complicated and contradictory”, noting that a lack of trust is sometimes an appropriate and healthy stance.

That last line is interesting, especially in light of online responses from a number of physicians who prefer to criticize the BBC for daring to expose this controversy rather than the actual controversy itself. Better to just pretend that what is happening is not really happening. . .

Dr. Khullar, who is in the Weill Cornell Department of Healthcare Policy & Research, told his colleagues at the same event three reasons that patient trust really matters:

• Trust makes people more likely to engage in healthful behaviors:  “Patients who trust their doctors are more likely to take their medications as prescribed, exercise, eat a healthy diet, and follow important instructions. Trust is critical for patient satisfaction and the development of long-term physician-patient relationships.”
• Trust helps us respond to public health crises: “A Liberian study, for example, showed that people who did not trust health officials were less likely to engage in precautionary measures to protect themselves and others from the Ebola virus.
• Trust can enable innovation: “Patients who trust their doctors are more willing to engage with new technologies and treatments, and trust is also among the best predictors of whether patients would participate in clinical research.”

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1. Stone GW, Sabik JF, Serruys PW, et al. “Everolimus-eluting stents or bypass surgery for left main coronary artery disease.” N Engl J Med. 2016.

Heart image: American Heart Association

NOTE FROM CAROLYN:   I wrote more about cardiac interventions in my book, “A Woman’s Guide to Living with Heart Disease”. You can ask for it at your local library or favourite bookshop, or order it online (paperback, hardcover or e-book) at Amazon, or order it directly from my publisher, Johns Hopkins University Press (use their code HTWN to save 30% off the list price).

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UPDATE: March 6, 2020 from the British Medical Journal (BMJ):

The New England Journal of Medicine has launched a review into the EXCEL trial comparing stents with bypass surgery for blocked arteries, after a series of allegations made by the BBC’s Newsnight program.

Newsnight alleged that important data about myocardial infarction had not been published, and that the five year follow-up paper did not sufficiently emphasise that PCI (stent) patients had a higher mortality rate than those who had surgery..

The trial was sponsored by the US stent manufacturer Abbott and was led by Gregg Stone of the Cardiovascular Research Foundation and the Icahn School of Medicine at Mount Sinai in New York.

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Q:  Should physicians feel free to disagree publicly over controversial research?

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See also:

– the BBC NightNews investigative report from February 18, 2020 by investigative reporters Deborah Cohen and Ed Brown (who had been working on this report on the EXCEL study controversy for the past year).

– the brief official statement in response to this BBC NightNews report from the European Association of Thoracic Surgeons, issued on the following day, demanding an investigation, and announcing that their association was confirming their previous decision to withdraw support from the 2018 guideline recommendations on how to treat left main coronary artery disease.

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