Earlier this week a new study published in The Lancet rocked the world of cardiology, with the surprising finding that putting stents in patients with stable angina did not improve their symptoms any more than a placebo.
David Brown, professor of medicine at Washington University of St. Louis and co-chair of the Right Care Alliance cardiology council co-authored an accompanying editorial with cardiologist and JAMA Internal Medicine editor Rita Redberg. We spoke with Brown about the implications of ORBITA and the furious debate sparked by the study and his editorial.
Lown Institute: One of the main questions being debated about ORBITA is whether it provides enough evidence to start making immediate changes in clinical practice. Do you think it’s time for change or that we need more evidence first?
David Brown: I don’t think we need more evidence to start making changes in the doctor’s office. They don’t have to be radical changes. But we should discuss the results of this trial with stable angina patients, let them know that stents have not been proven to help their symptoms more than a placebo. Some patients will decide on their own that they don’t want the procedure. Change is made through open, honest discussions with patients.
Lown Institute: What are the barriers to doctors making these changes?
David Brown: For many, I think it’s an open mind. I won’t get into financial conflicts of interest, which are an issue as well, but more important is a lack of intellectual openness. It’s hard to think that the procedure we were trained to do for so many years doesn’t actually help patients. But if cardiologists look at the evidence objectively and with an open mind, that should be all it takes for them to make changes in how they talk to patients about the issue.
Patients should be driving this boat. The decision about whether to put in a stent for stable angina is not a life-or-death issue, it’s a quality of life issue, so patients should be making the decision after they are informed of all the benefits and risks.
Lown Institute: Critics of the study are saying ORBITA isn’t telling us anything we didn’t already know, that the study isn’t that significant. How big of a deal do you think the study is?
David Brown: It is a big deal! I’ve said it’s the second most important coronary artery disease trial in the current century, after COURAGE [a study that showed that stents did not reduce future heart attacks in patients with stable angina]. This should be a paradigm-shifting, practice-changing trial.
When I communicated with the senior author of ORBITA, he said that they thought all along the study would be positive, that they were surprised at the results. But no matter how they sliced it, they couldn’t find an advantage to PCI [stents].
Lown Institute: How would you respond to some of the criticisms people have said about the trial structure and methodology, such as the relatively low severity of angina in the patient sample?
David Brown: The severity of angina in the ORBITA sample was similar to patients in COURAGE and a more recent trial called FAME 2, which found PCI was effective. I didn’t hear cardiologists saying that there wasn’t enough angina in FAME 2.
A lot of people are saying, “these patients could already go eight minutes on a treadmill after medical therapy, they couldn’t improve more.” But if they took a closer look at the study they would see that the patients in ORBITA were not using standard treadmill test protocol, they were given a much easier treadmill protocol. So there was potential room for improvement.
The fact that ORBITA patients only had single-vessel blockages is a legitimate criticism. It’s possible that we could find in a future study that PCI works for patients with multiple-vessel blockages. But that would mean that stenting doesn’t improve patients who have mild chest pain but would improve patients with more severe chest pain. That logic doesn’t really make sense. That’s like saying, I have an antibiotic that won’t work for people with simple bronchitis but will work on patients with severe pneumonia. Usually an effective treatment works on everybody! The onus is on people to prove that this treatment works, not that it doesn’t work.
Lown Institute: What do you expect the response from industry will be?
David Brown: It’s already happening. I think industry is somehow behind the backlash on Twitter already. Even before ORBITA the stent business has been declining, so they’re trying to revive the market.
But it’s not unexpected. There was similar backlash after COURAGE, the difference was that Twitter wasn’t popular, so you had to actually write an editorial to make your point. Now anyone can make a point, you don’t even have to have read the paper.
Lown Institute: Thanks so much for speaking with us!