A Trial that Upends an Everyday Practice in Cardiology

Chapter 4 of our series on coronary heart disease treatment considers the REVIVED-BCIS trial. You must sit down. And read this trial more than once.

In Chapter 1 of this mini-series, I explained the disruption wrought by the COURAGE trial. Seriously? Stenting severe coronary lesions did not improve survival over simple tablets?

Chapter 2 added to the oodles of studies showing how much doctors can be fooled by the placebo effect. The ORBITA trial demonstrated that the caring signal of placing a stent is massive.

In Chapter 3, I discussed the ISCHEMIA trial, which demonstrated that even in patients with substantially positive stress tests, there was no advantage to the common practice of immediate coronary angiography with intervention.

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These were all eye-opening trials. But today I present an even more surprising one. It’s called REVIVED-BCIS. Seriously. It is shocking. Buckle up.

First some background. Not every day in the average American cardiac cath lab, but many days, a patient is referred for angiography (pictures of coronary arteries) because of unexplained heart failure.

The idea is that since coronary artery disease is common, the reason for a weak heart muscle could be multiple partial blockages. And fixing these obstructions would restore flow to the heart muscle and function would improve. Indeed, multiple diffuse partial blockages are often found, and then fixed—with either stents or bypass.

This practice dates back decades. It makes perfect sense not to leave a patient with a weak heart muscle with major obstructions to flow.

In the old days, patients with multiple coronary obstructions were treated with surgical bypass. Stent technology has improved. And the advantage of using stents to improve blood flow is that it’s less invasive.

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The brave investigators in London decided to study the idea that medical therapy of heart failure has become so outstanding, that adding revascularization (fixing the obstructions with stents) might not improve outcomes.

For REVIVED BCIS, they set up a trial that gave stenting every chance to win. Patients had to have a weak heart muscle and viable heart muscle and the lesions had to be suitable for PCI/stents.

Then half got tablets only; the other half got tablets plus stents. Their primary outcome was death or hospitalization for heart failure.

Sit down for this. After 3.5 years, here was the result.

Look at that. Not a shred of difference.

Also shocking was the secondary findings. They found no difference in heart function. Opening all those obstructions with stents did not improve heart squeezing function over simple tablets. There was also no difference in patient-reported quality of life.

They found no subgroup of patients that benefited more from the intervention.

Comments:

REVIVED-BCIS was published 10 months ago. But.

I bet in cath labs across the US today there will be patients referred for a look at the coronaries to assess the cause of a weak heart. When the doctor finds multiple obstructions, he or she will open them with stents.

Improving blood flow to improve heart function is one of the most established ideas in all of cardiology. Yet the REVIVED-BCIS authors set up a near perfect scenario for stents to win, and they did not.

Why not? I do not know. But it DOESN’T MATTER.

In a trial with 700 patients—of which more than a third had a primary outcome event, there was no difference.

The results of REVIVED-BCIS should change practice. It should change our thinking about the nature of the clogged-pipe frame of heart disease. It should make us humble.

But it might take a generation—like Max Planck suggested.

I urge you to study this trial. It is one of the bravest most consequential trials of recent years. It represents the best of medical science. And I am happy to show you science done well.