–Brahmajee Nallamothu fills in the details about the patient who didn’t get a stent because of ORBITA.

Editor’s note: The New York Times story by Gina Kolata on the ORBITA trial focused on one patient who decided not to have a stent implanted when he heard about the ORBITA trial. Here is a more complete version of his story by Brahmajee Nallamothu (University of Michigan), his cardiologist.

ORBITA is a big deal.

And the story by Gina Kolata in the NY Times about ORBITA featured my patient, Jim Stevens. In the interim I’ve received a number of questions about details regarding his case from friends and colleagues. Jim has been incredibly generous enough to allow me to share some of his story for those interested. For better or worse, he knows he’s been linked up to one of the most controversial trials in contemporary medicine. He hopes his story can help others understand their disease.

Without divulging every detail, Jim had a proximal LAD stent placed years back. And for the most part, he has done really well. He had a single episode of exertional chest discomfort a few weeks ago that prompted a stress test. He went pretty far on the treadmill portion but the imaging portion suggested inferior wall ischemia. I cath’d him on Tuesday. That showed his LAD stent was open but that he had mild progression of a blockage in his mid-LAD that had been there over a decade earlier. I would have typically FFR’d that blockage and possibly put in a stent if the FFR was abnormal. But I do admit that ORBITA, which I had just reviewed under embargo, made me pause for a moment. He has had no recurrent symptoms and has been doing well. We definitely had room to push medications. What’s the point I thought to myself of going further even with an FFR?

His wife is a doc. I actually spoke with her while Jim was on the table and showed her the angiogram. He’s also completely on top of his condition given his prior history. She said that if he didn’t need a stent, then we should stop because that’s consistent with his wishes. He definitely didn’t “need” a stent at that moment. I went back, and Jim concurred (but he might not have remembered that immediate conversation because of the sedation we gave him). I did speak with him after, and we all agreed that we’d add a medication and see him back in a month to re-evaluate.

That’s the story. Admittedly, it’s a lot of text and much of it is probably distracting and less relevant for non-technical audiences. I can personally see why Gina Kolata focused where she did; others obviously disagree and thought the piece was “sensationalized.” The fact that I liked Gina’s story doesn’t diminish my opinion of the wonderful piece by Bill Boden, Ajay Kirtane, and Dan Mark on CardioBrief and Medpage Today. The articles are really written for different audiences. If you don’t believe me, ask a non-cardiology friend to read the Medpage Today piece and see what they say. This is complicated, and it’s our job as docs to help our patients put lay media interpretations into an individual context.

Of course, this also doesn’t mean I don’t care about the nuances and details of ORBITA. It is a super important trial that was beautifully designed and audaciously conducted – but with key limitations. It also will be a gift to conference planners: I’m sure we’ll see plenty of “pro-con” debates on ORBITA in the coming years to the point of fatigue. Although I personally don’t believe that 200 patients should make us change our guidelines, I do believe it should force us to look more carefully at our conversations with patients considering PCI. Try explaining ORBITA and its findings to a patient and see if you don’t feel differently after you describe the impact of a sham procedure to a layperson.

The reality is that Jim like some patients with CAD is at the “margin” of benefit for PCI. On one extreme we have STEMI and shock patients where we all agree stents save lives. On the other end we have asymptomatic patients with non-ischemic blockages where we all agree stents offer no benefit. Patients like Jim live in a gray area where I believe the only truthful answer is that we don’t really know if PCI will be ultimately valuable. Thus, smart, kind and honest docs will disagree as to the best approach for him. Seeing conflicting chatter over the last 24 hours on Twitter between experts I deeply respect on both sides of this debate makes me believe this fact only more.

I used to believe that CAD was a well-described disease with decades of clear evidence to guide us. And PCI, which is now 40 years old, is a well-established therapy. But I readily admit that several of the blockages the authors displayed in their Appendix – which was a brilliant idea by the way – I would have probably stented 10 years ago just based on the pictures alone. This was before COURAGE, FAME and the other landmark trials that have guided us. This is part of the evolution of our field. It has been a part of my own evolution as an interventional cardiologist.

–Brahmajee Nallamothu

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7 Comments

  1. “Although I personally don’t believe that 200 patients should make us change our guideline”: sure, not if there’s an equally competent trial on 1,000 patients that points in the opposite direction. Is there?

    Or do you mean that doctors ought to take time to absorb the lessons of the trial and probe it for weak points? That would seem reasonable to me, but then I’m not a patient impatient for the most up-to-date recommendation.

  2. Now would be a very good time for an in depth report on EECP as an effective and non-invasive alternative to stenting and, indeed, even CABG.
    (You haven’t heard of it?? EECP = Enhanced External Counter-Pulsation)

    1. I can promise you I know what EECP is! I covered it extensively long ago. I believe that it MAY confer some of the benefits of exercise in CAD patients who can’t or won’t exercise. But I can also tell you that it is completely dead in the cardiology and medical community, and there is absolutely no chance of any significant increase in its usage until or unless a new trial is performed. Seems very unlikely.

      1. Well, perhaps as cardiologists lose the opportunities to do PCIs as this information filters to the general public, they’ll turn to something else that actually shows benefit. I know, it’s not dramatic or instantaneous, but I have to believe there are enough thoughtful cardiologists out there who want to make a difference notwithstanding.

  3. Mr Lary Husten, your blogs are also read by non-medical persons. They are eminently readable. The fly in the ointment at times is some acronyms which many physicians and some readers only may understand easily. In the present blog,ORBITA, LAD, PCI, FFR, COURAGE,FAME, EECP, and CABG are examples.We can identify some of them as the names of trials. Others crept into the blog as they are used by Dr. Brahmajee Nallamothu. May be you can leave a list expanding the acronyms at the end.

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