Interventional cardiology

ORBITA Trial Puts Interventional Cardiologists On The Defensive

Since it’s debut a week ago the ORBITA trial has provoked the most furious debate in cardiology since the COURAGE trial a decade earlier. But the ORBITA debate has proceeded far faster, fuelled by Twitter and its ability to  instantaneously deliver point and counterpoint. Although ORBITA has been showered with praise for its innovative design, in particular for its use of sham controls, the trial has completely divided the cardiology community over its implications for the use of PCI in stable angina patients.

On one side of the debate, a chorus of prominent interventional cardiologists and their supporters have sought to dampen the impact of the trial, saying that the trial tells us nothing that we don’t already know while also saying that the trial is completely incapable of informing any change in clinical practice.

On the other side, the more skeptical part of the cardiology community believes that ORBITA casts serious doubt on the the benefits of PCI in some patients with stable angina, providing a long needed corrective to the hubris of interventional cardiology.

Anupam Kumar Singh, a cardiologist in Delhi, pointed out on Twitter that the attack on ORBITA followed the same pattern as the attack on COURAGE, which George Diamond and Sanjay Kaul wrote about at the height of the COURAGE debate: Schopenhauer said that “truth passes through 3 stages: ‘First, it is ridiculed. Second, it is violently opposed. Third, it is accepted as being self-evident’.” But, they write, the COURAGE critics “reverse this journey,” and so, according to Singh, do the ORBITA critics. These critics start off by first stating that the trial results are obvious and conform to current guidelines but then end up dismissing and ridiculing them.

A dominant theme of the opposition is that the trial was somehow “unfair,” that it was designed for PCI to fail. Many interventional cardiologists have argued that in their practices ORBITA type patients would not normally get stented without first being given a chance on optimal medical therapy (OMT). But it also seems clear that in the real world many of these patients do get PCI, as soon as a critical stenosis is found on their angiogram.

Suneet Mittal (Valley Health System) said that “in my opinion, when a patient reports chest pain and a decision is made to proceed with an angiogram, discovery of a high grade stenosis typically leads to PCI. Maybe there are doctors who take patients off the table and start up titrating medications, but I do not see that in my routine clinical practice. I would even go so far as to say that most patients would expect and want (until now) that such a lesion be revascularized.”

Now it is undoubtedly true that there are many principled interventional cardiologists who would hold off before proceeding to PCI. Ajay Kirtane reported on Twitter that, in the wake of COURAGE, many interventionalists “titrate anti-anginals prior to catheterization so that if they have improved with OMT there is no reason to obtain the angiogram that provokes the oculo-stenotic reflex.” But Kirtane’s remarks contain a tacit acknowledgement that this is not always the case, and that there are in fact ORBITA-type patients who do undergo PCI without first being offered OMT.

William Boden said that “the real sad news here is the degree to which the lay public is uninformed” about PCI for stable angina, an issue which is “very complex and nuanced. On the one hand, we see ads, billboards, and other advertising that supports PCI as being lifesaving for heart attack, while on the other hand, many otherwise naïve or uninformed individuals don’t really understand the distinction between STEMI/ACS and SIHD—especially when words like coronary ‘blockages’ are used to describe this condition… Is it any wonder that the lay public struggles to understand this? And, the interventional community really does little to clarify these blurry margins (e.g., ‘I can open up and fix that artery’), while what the patient takes away is the cardiologist can cure that’.”

Here’s another way to look at this issue: if the critics are correct that because of its relatively healthy patient population ORBITA was incapable of showing any benefit of PCI it is then also true that this means that ORBITA-like PCI patients can not benefit from PCI. You can’t have it both ways.

Where is the outrage and concern in the interventional community about the millions of stable PCI patients over the decades who it now appears may have received no benefit from PCI beyond a placebo effect. Why, it is fair to ask, do the ORBITA critics fail to also focus their attention on the interventional cardiologists who rush their patients into PCI? As Boden mentioned, there is little effort made to educate patients and the public about the true benefits of PCI. I’ve personally never met anyone with a stent who didn’t think that their life had been saved by the procedure. What have the interventional cardiology leaders done to help prevent the widespread misconception among patients that PCI is nearly always life saving?

Mohamed Elshazly (Cleveland Clinic) similarly pointed out that ORBITA represents “a huge call to review fundamental procedural practices.” Haider Warraich (Duke University) made a similar point: “People can nitpick the study as much as they want, but burden of proof should be on the procedure to show an advantage.”

It’s also fair to wonder why the interventional cardiology community has gone into overdrive criticizing ORBITA but has been noticeably quiet about other, far more consequential developments. Compare the reception of ORBITA, which sparked immediate furor, with the response to the Absorb stent, which represents a massive and significant failure of the entire system to develop and approve cardiac devices. I have not seen a whole lot of deep reflection and anguish in the interventional cardiology community about Absorb. Why has there been so much scathing criticism on ORBITA but so little about the long Absorb trainwreck? Despite the highly questionable data, at the time of its approval the main disagreement among the leaders of interventional cardiology was how high would be the percentage of patients who would receive the new stent.

Perhaps, instead of serving as cheerleaders for new devices, the interventional cardiology community should take a lesson from the ORBITA investigators and insist that new devices and procedures undergo truly rigorous testing. Anything else is a sham.

Previous coverage of ORBITA:

Update: William Boden sent the following comment in response to this story:

I would point out that there is “a chorus of prominent cardiologists”–not just interventional–on both sides of this debate. Those who have lined up in support of the ORBITA findings are not only clinical cardiologists, but many interventionalists as well who, excuse me, have the “courage” to break ranks with their interventional colleagues. It would be unfair and overly simplistic to portray all of interventional cardiology as a monolithic subspecialty.

But, to quote the noted philosopher, Yogi Berra, this is “deja vu all over again”. In the aftermath of COURAGE, the constant refrain was “COURAGE tells us nothing new–we’ve known for years that PCI doesn’t reduce death or MI. That’s not why we do PCI for stable CAD, we do it to reduce angina and improve the quality of life”. For this reason, clinical practice guidelines endorse PCI for angina relief if medical therapy fails or is ineffective. It has been the universal justification to perform PCI in SIHD patients in conformity with existing guidelines post-COURAGE and BARI-2D. Now, ORBITA confronts head-on this sacred cow of PCI benefit for angina relief and QOL improvement, so the pushback is now front and center to disparage, denigrate, and dispel the findings as inconsequential.

The parallels between ORBITA and COURAGE are striking and inescapable. 10 years ago, the criticism of COURAGE was that, because we did not use drug-eluting stents (though the stent manufacturers would not provide them for us), the “PCI was substandard” while, on the other hand, we were told repeatedly that the OMT used was “too good”, “not real world”, was “too hard to achieve”, and “could not be replicated in routine clinical practice”. Just like with ORBITA, you can’t have it both ways. And, to this day,that general dismissiveness or complacency about embracing the powerful benefits of OMT is what best explains the continued, suboptimal utilization of OMT to this day.

We need to be honest that our biases and pre-existing beliefs about the benefits of PCI color the way we approach this discussion with patients. As Dr. Mittal recounts, when even a stable CAD patient is found to have a flow-limiting coronary stenosis during angiography, what is frequently conveyed to the patient (along with the frightening appearance of an angiographic obstruction) is an impending catastrophic event: if we don’t intervene and “fix this blockage” right here and now, something very bad could happen. In this context, who could blame a patient for acquiescing to PCI? But, I suspect there is little discussion about the lack of PCI benefit on improved survival or reduced MI in this setting–though well there should.

And, the looming question now post-ORBITA is: will we need to start informing our patients that PCI may not necessarily improve their angina either? Time will tell…

This article has been republished from Larry’s blog CardioBrief as part of a licensing agreement between Everyday Health and the limbic.

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