Nov 13, 2026 This Week in Cardiology

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John Mandrola (0:41)

Hi, everyone. This is John Mandrola from the heart.org Medscape Cardiology. And this is This Week in Cardiology for November 13th, 2026

This week, some listener feedback on the progress trial. The first, Factor 11 inhibitor has been approved. Left bundle branch pacing versus RV pacing. And statin discontinuation in the elderly. And some super interesting trial and analytic issues.

On a personal note, it took me two weeks to recover from the half marathon that I ran with my daughter.

And secondly, there's been Norwegian and Danish weather that have hit Louisville, Kentucky. And it is cold and rainy. And winter is here, sadly. All right, listener feedback. I received two notes about my coverage of the progress trial of TAVR versus clinical surveillance in patients with moderate aortic stenosis. I was pretty hard on the trial. The results were driven by heart failure events rather than heart events. And one of the heart failure events could be conversion to TAVR. Of course, it's an unblinded trial. Their KCCQ positive findings for the TAVR arm is biased because it's an open-label trial. The subgroups in progress went the wrong way in that less sick patients did better than those with worse AS. You'd expect it to be the opposite. And of course, there was safety issues where nearly 6% of TAVR arm patients had a serious adverse event. So, I received this note from a prominent professor in the UK, and I'll just leave him nameless. And he writes, John, I just wanted to say, I listened to your podcast today about the progress trial and punched the air. It was totally brilliant and spot on. Why can't New England Journal of Medicine provide similar analysis in its review process? Thank you for speaking out. It does sometimes feel the game is rigged, but at least you're shining a light on it. I really appreciate that note. Now, this is a positive note, but I also appreciate criticisms as well.

The second comment came from Dr. Ben Costello in Melbourne, Australia. He said that, first, I particularly appreciated your aside about grades of diastolic dysfunction, quote, whatever that means is what I said. As a cardiac imager, I've never understood why we insist on assigning grades of diastolic dysfunction rather than simply describing what we're actually measuring. The diastolic filling pattern and an estimate of filling pressures. I mean, giving something a grade that non-imaging cardiologists, let alone everyone else, then need to look up to understand seems an unnecessarily convoluted way of communicating a relatively straightforward finding. And so I'll say to that, thanks for that, Ben.

Dr. Costello then went on to discuss the progress trial. And he said it highlights what he thinks is one of the biggest problems with endpoints in cardiovascular trials. And that is, including an event in the primary composite endpoint, while not counting the equivalent event, when it occurs as part of the allocated intervention. In the case of progress, 100% of patients randomized to TAVR underwent a procedure that was itself a component of the primary endpoint, when performed in the control arm. Yet those procedures are effectively invisible in the endpoint analysis. This leads to the rather absurd situation where a supposedly positive trial with an impressive looking NNT of 14 and a small p-value could essentially be interpreted as performing 14 TAVRs to prevent one TAVR, or in this case, one TAVR or heart failure hospitalization. The latter is also somewhat subjective endpoint and arguably no more burdensome to a patient in admission for TAVR itself. In this problem, he writes, extends well beyond valve trials. Dr. Costello has long agreed with my skepticism of complete revascularization after ACS. He writes, trials in this space often include urgent revascularization in composite endpoints, yet all patients allocated to the complete revascularization arm undergo additional procedures that, from the patient's perspective, may be very similar to the urgent revascularization we're trying to prevent. One is counted as an adverse outcome, the other is considered successful treatment. So he writes, from complete, the results were framed as positive. 11% mace vs. 7% mace, approximately, p-value significant, whereas from the patient perspective, it was 11% vs. 107%.