CardioExchange Archive

CardioExchange asked Gregg Stone, Director of the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting, what he thinks will be the three most important trials or topics presented at this year’s conference.

The most important and impactful trial is undoubtedly the PARTNER trial, which is a large randomized trial of transcatheter aortic valve implantation compared to medical therapy in patients with inoperable aortic stenosis. If the trial is positive, it will usher into the U.S. a whole new field of transcatheter valve therapies specifically related to aortic valve stenosis. We’re very excited about that, no matter what it shows, positive or negative. The trial also has worldwide implications, because tens of thousands of these procedures have now been performed globally. A large-scale, randomized trial like this trumps everything else.

The second most important trial in my mind is ZILVER PTX, which is the first trial in a long time to test a drug-eluting stent in the peripheral arteries. There’s been very little in this area and this is a new paclitaxel-eluting stent optimized for the periphery. This trial might also have a big impact on the field, in that it could establish a whole new territory for stents.

My third choice isn’t one trial, but a group of trials testing everolimus-eluting stents, which are by far the most popular stents used in the world today. We’re going to see several very large trials that will either further establish their position or reveal their weaknesses. Two-year results from the SPIRIT IV and COMPARE trials will contain data on nearly 6,000 patients. The everolimus-eluting stents looked great at one year, but how will they look at two years? That’s a key question. In addition, the comparator in these studies used the relatively weak paclitaxel coating. At TCT this year we’ll see several trials with a total of 5,500 patients randomized to either everolimus-eluting or the equally potent sirolimus-eluting stents, so it will be much more difficult for the everolimus-eluting stents to demonstrate superiority in these trials.