What can you tell us about your practice and your facility at Columbia University Medical Center?

The Center for Interventional Vascular Therapy is a diverse practice committed to all of the endovascular treatments of cardiac disease. We work in virtually every area of the vascular tree, from the carotids down to the ankle. We pride ourselves on clinical excellence but also in innovation and participation in many clinical trials.

What is the current focus of your research energy?
Our focus is very diverse. We are seminally involved in all phases of drug-eluting stents (DES) and virtually all of the US approval trials for all of the currently commercialized stents. We are also involved in DES drug development and specialized stent development, including bifurcation stents and erodable polymers. We work heavily in novel antithrombotic treatment of myocardial infarction (MI), acute coronary syndromes, and ATP inhibitors. We have a major trial that Gregg Stone, MD, is leading called ADAPT DES, which is looking at this prospectively.

We are involved in all phases of stem cell research: applications for myogenesis and refractory ischemia. Also, we deal with structural heart disease, including leading the trial for the Edwards Lifesciences' (Irvine, CA) Sapien percutaneous aortic valve. We are the lead enrolling site for the Sapien trial. We also deal with patent foramen ovale closure, patent foramen ovale closure and migraine, as well as all of the major carotid trials, and thoracic and aortic aneurysm repair.

Which areas in coronary artery and structural heart disease need the most attention from physicians and industry in the next several years?
In the coronary arena, certainly there is still room for a major improvement in the safety of drug-eluting stents in terms of minimizing the dependence on antithrombotic therapy. I think reducing that need will promulgate this therapy further and make it even more robust. That is priority number one, and there are many different solutions to it.

In the structural arena, the most exciting area is that of percutaneous valve replacement and repair. The aortic valves have become the most advanced at this point and are certainly going to become part of our therapeutic armamentarium in the next few years; however, there is still room for major improvement. And then comes the extension of treatment into other aortic lesions, as well as the mitral arena (especially the structural and functional), where the technology seems to be lagging a bit.

What recent developments in coronary artery and structural disease have had the greatest impact in successful outcomes?
On the structural side, there is no question that the aortic valves have emerged from a rather messy beginning. We have learned many lessons in terms of technique and technology since the early days. I think they are going to have a profound impact and will capture the imagination of the community in terms of realizing that there is a whole new array of individuals who have literally been written off and are now candidates for treatment.

In the coronary area, despite the major speed bumps encountered in 2006, there is no question that DES have extended our reach and our ability to revascularize a new group of patients who previously would have been subjected to bypass surgery. I also think that the advent of DES renewed interest in the treatment of chronic total occlusions, which had been a major barrier.

What can we expect at TCT 2008?
TCT will be quite exciting because it is the 20th anniversary of the meeting. It is an opportunity to look back but also to look forward because it is also the 20th anniversary of the coronary stent. Additionally, it is the 30th anniversary of the first application of angioplasty for direct recanalization of acute MI. That is a lot of cause for celebration.

At the same time, with the advent of new areas of treatment for structural heart disease and valvular heart disease, we can expect to see a lot of activity in innovation. And, of course, as we extend into the coronary area, there are many landmark trials coming out to help define the place of surgery, stenting (specifically drug-eluting stenting), and the treatment of new areas of coronary disease that traditionally have been believed to be out of the realm of percutaneous therapy.

What studies in the coronary and cardiac space will draw the most interest at TCT this year?
I think one of the two major trials to watch for is going to be the SYNTAX trial (the overall results of which are to be presented at the European Society of Cardiology meeting before TCT). However, there are two separate studies within SYNTAX: (1) the multivessel study and (2) the left main study. The breakout of those two studies will be presented at TCT. I think the results of these will be phenomenally illuminating and potentially controversial.

Another trial to look for is the HORIZONS trial, which not only compares bivalirudin to heparin plus IIb/IIIa inhibitors for ST-elevation MI (1-year results to be presented at TCT 2008), but more importantly, the randomized portion of Taxus versus bare-metal stenting in acute MI (1-year results to be presented at TCT 2008). This will by far be the largest trial looking at bare-metal and drug-eluting stenting in acute MI.

Other trials to be presented (eg, SORT OUT III) will compare the Endeavor (Medtronic Inc., Minneapolis, MN) stent in a large randomized manner to the Cypher (Cordis Corporation, Warren, NJ) stent. There will also be other new multiple comparative studies of different pharmacologic treatments for acute MI.

There have been recent additions to the DES toolbox. What impact do you anticipate these additions will have, and what do you look forward to from the next generation of DES?
There are two issues. The first issue is the deliverability of the Endeavor and the Xience V (Promus) stents (Abbott Vascular, Santa Clara, CA; Boston Scientific Corporation, Natick, MA). There is no question that their deliverability is far superior to that which we have seen previously. The second issue concerns the efficacy and safety: Are they better than their predecessors? The data are still early in that regard. There are no indications at this point that they are less safe than their predecessors. They are welcome additions, and I believe that they will end up being the predominantly used stents in the US.

Considering the concerns about long-term clopidogrel use after stent placement, are DES the ultimate answer from a technology perspective? Or, do we need to look elsewhere, perhaps to bioabsorbables?
I think the jury is still out on the bioabsorbables. They represent a huge challenge, and it remains to be seen if they can be developed into a tool that has the same diverse applications and deliverability as the metal stents.

Having said that, there certainly are novel areas being explored, especially with nonstent drug delivery, which open up potential new areas of treatment of distal and diffuse disease and potentially marry nonstent drug delivery to bare-metal stents as an adjunct. There will be data along these lines presented at TCT this year.