The late-breaking clinical trials at the American College of Cardiology (ACC) scientific sessions often draw large crowds. Prediman K. “P.K.” Shah, MD, co-chair of the ACC.14 Program Committee and director of two atherosclerosis centers at Cedars-Sinai Medical Center in Los Angeles, shared details about this year’s offerings with Cardiovascular Business. ACC.14 will be held March 29-31 in Washington, D.C.
CVB: What did you learn from last year’s program that you implemented in this year’s?
PKS: We learned that we have to be tight about our embargo policy for the late-breaking clinical trials. If anybody breaks the embargo then we have to take a serious view of that.
How are you making it tighter?
No. 1: We are keeping an eye on all news media to make sure no one is leaking the information. We have set up a system so that all major players in the decision-making process will be informed immediately.
Have you made it clear to sponsors that you will be rigorous?
We have shared that policy. In fact, this year one of the industries anticipated that they would have to provide some media coverage because of SEC [Securities and Exchange Commission] requirements, so they ran by us what would be the acceptable parameters for [posting] information ahead of the presentation. We gave them guidance.
Medtronic announced that SYMPLICITY HTN-3 had failed to meet its efficacy endpoint. Does that diminish the value of the presentation?
Not at all. There are several very important questions that still have to be answered. No. 1, why did it fail? Was it because the concept was not sound or was it because the technique they used did not achieve denervation? The presentation is every bit as important even if it has a negative result. In fact, I think this will be a hot topic at the meeting because people will start asking for the reasons.
Is it an opportunity to talk about the different ways trials are designed, for instance, the difference between the previous SYMPLICITY trials and this one?
It had very tight criteria. As a clinical trial, it was very well designed. The question is, did the technique work? Was the technique adequate in accomplishing the goal of denervation? If denervation was accomplished and it still failed, either answer would be of great interest. One would say you need to improve your methodology, the other would say you are barking up the wrong tree.
At least two trials this year are based on registry data. What are the advantages and disadvantages of this approach?
I personally did not review the registry trials because I was out of the country during that process, so I can’t comment specifically. But in general I think the registry data are very important. They can provide unique insights into the real-world practice and the implications in the real world outside the constraints of the clinical trials.
The clinical trials generally are highly constrained with a pre-selective process and the results from a highly selected group subject to a clinical trial may be different from the experience when you expose a drug or a procedure out in the real world. Registries provide a very valuable piece of information. Well-conducted registries can be of great interest.
What topics do you predict will be hot in 2015?
I think the PCSK9 lipid management therapy continues to be very exciting. In 2015, hopefully by then we may have trials on CETP inhibitors completed. That would be an exciting topic for next year. Renal denervation will continue to be an important topic for investigation. And finally, some of the stem cell trials might have been completed by then for presentation.