What Are the Real Lessons from the ORBITA Trial?

— Milton Packer thinks that the trial teaches us more about people than about cardiology

MedicalToday
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Much of the cardiology community has been consumed in recent weeks by the presentation and publication of a clinical trial, known as ORBITA.

If you don't know about ORBITA, here is the story. In a randomized trial, patients with stable angina (even with severe stenosis) had a similar relief of symptoms and improvement in exercise capacity, whether they underwent a percutaneous coronary intervention (PCI) for single-vessel disease or had a sham procedure.

Do you think that such a result might upset some people?

Just think about it. If PCI is not warranted in ORBITA-type patients, then millions (billions?) of dollars are being spent for a procedure that does not add anything to current medical therapy.

If payers stopped paying for PCI in ORBITA-type patients, then cardiologists, hospitals and medical schools would lose a major funding source. The negative financial impact would be incalculable.

So it makes sense that physicians whose livelihoods depend interventional cardiovascular procedures might be hesitant to embrace the findings of ORBITA. As Upton Sinclair wrote: ""It is difficult to get a man to understand something, when his salary depends on his not understanding it."

I am not an interventional cardiologist, and I have no vested interest here. But the real story about ORBITA is not what the trial showed. The real story is how people have reacted to it.

The reaction has not occurred in the medical literature or at scientific meetings. This drama has been played out on social media -- to a degree that is unprecedented.

ORBITA is going to have a lasting legacy, but not because of its impact on clinical practice or on our thinking about coronary artery disease. The legacy of ORBITA is: If an investigator presents the results of unpopular research at a scientific meeting, he/she should be prepared to fight in an all-out war on social media or digital news sites for a long period of time.

They don't teach you about that in medical school.

How bad is it?

The principal investigator of the ORBITA trial, Darrel Francis of the Imperial College in London, opened a Twitter account to defend the trial from attack. And he has been really busy. He has been deflecting attacks coming from hundreds of different sources. I think Darrel is going to need to hire both a publicist (and a bodyguard!) in order to maintain any stability in his life.

But the most incredible part has been seeing what people have actually said on the record. Some are saying that PCI did not work in the trial, because patients were receiving medical therapy that was too good.

Huh?

Yes, you read that correctly. Some say that the trial would have succeeded if patients had been getting suboptimal care. I guess that means that only physicians who treat their patients suboptimally should be performing PCI on them.

But the quote that I like the most is one that I took from the TCTMD website that was attributed to Samir Kapadia,MD, (from Cleveland). It seems that he hates the trial and thinks it proves nothing. His quote: "I do angioplasty and I have grateful patients. It's not rocket science for me to figure out if [PCI] works or not."

In medical school, they used to teach that you should not say things like that in public, even if you believe them. I guess they must have stopped teaching rocket science to cardiologists.

The ORBITA trial may or may not have taught us something important about coronary artery disease, but it definitely taught us about the weaknesses of human beings -- and how social media just makes everything a lot worse.

Disclosures

Packer recently consulted for Amgen AstraZeneca, Bayer, Boehringer Ingelheim, Cardiorentis, Daiichi Sankyo, Gilead, Novo Nordisk, Relypsa, Sanofi, Takeda and ZS Pharma. He chairs the EMPEROR Executive Committee for trials of empagliflozin for the treatment of heart failure. He was previously the co-PI of the PARADIGM-HF trial and serves on the Steering Committee of the PARAGON-HF trial, but has no financial relationship with Novartis.