ACC.15: TOTAL provides clarity for interventional cardiologists

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SAN DIEGO— Cardiovascular Business met with Ajay J. Kirtane, MD, SM, from the Center for Interventional Vascular Therapy and chief academic officer at Columbia University Medical Center in New York City, on March 16, the closing day of the American College of Cardiology scientific session. Here is what he offered as highlights.

The interview has been edited for brevity.

CVB: What has been outstanding today?

AK: The TOTAL trial is a pretty big trial for interventionalists. A lot of interventionalists do thrombectomy because it makes their case easier to do. Unfortunately, a case that is easier to do is not an endpoint that is often measured in clinical trials. But yet you would like to see if there was some other benefit to thrombectomy, besides making your case easier. That is what led to some of these larger trials like the TASTE trial and TOTAL.

With the results of this trial, there did not seem to be—at least by my read—a clear advantage of doing routine thrombectomy over conventional care. That is important because some have advocated we should be doing this in every case, whether for some other benefit or because it makes the case easier. Here we are not really seeing measurable outcomes that demonstrate a significant difference. In this trial there was a slight increase in stroke at 30 days and even beyond that point. We need to learn more about what those strokes specifically were.

There are ways to liberate the thrombus in the vessel during thrombectomy but that also can happen during standard conventional balloon inflation. There are technical things you can do to limit that from happening. It would be interesting to see the timing of the strokes, the types of strokes. There is always hemorrhagic stroke, not just ischemic stroke.  We need to find out more about that before we can say there is increased harm.

If it makes your case easier but it harms the patient, then you shouldn’t do it. If it makes your case easier and there is no harm associated with it, that makes a case for selected use.

CVB: Were there other presentations?

AK: Yesterday was a big day for transcatheter valves. It is almost historical now in the sense that the field has been around for about 10 years or more. The rates of adverse events that we see with the SAPIEN 3 registry trial are really remarkable. The higher risk population [was] approximately 2 percent and the lower-risk population approximately 1 percent, and the rate of stroke with good neurological follow-up was about 1 percent. That is amazing.

That is why I say it is of historical relevance. The CoreValve trial two-year results clearly demonstrated a mortality benefit over surgery in addition to all the other benefits we see. For the field as a whole, we have reached a sort of tipping point now where you can begin to start asking the question, who shouldn’t get TAVR and who should be offered surgery.

Until now, patients have been asking for it. Patients don’t want a sternotomy; they want a low-risk procedure. It is a little early in the sense that we don’t have long-term data. That is really important. Even comparisons to early historical surgical controls are going to be difficult because the surgical valves haven’t been arrested for 10 years; they have evolved as well. Still, not having a sternotomy is a big deal for patients. It is not just sternotomy. The rates of stroke after a conventional valve surgery are not insignificant, either.

CVB: Does the overall conference seem different this year?

AK: San Diego is amazing. It is such a nice place. For those of us on the East Coast, it changes the mood of the entire event. It is a beautiful venue and the way they set it up has been great. One of the things that everyone has struggled with is our field is becoming more and more siloed. The ability to try integrate across fields is something all conferences are going to have to strive to do.

CVB: Is ACC doing something different this year to try to break down those silos?

AK: Yes, there are sessions that involve folks from different areas. I am a physician with the Cardiovascular Research Foundation and we have worked with the ACC for a long time on interventional sessions. We do that actively. I have been on the ACC Programming Committee and it is encouraged.

The other thing that is great about the ACC is they have an emerging faculty program. There was a reception last night that I participated in where we thanked the ACC leaders for allowing that to occur. It is an amazing