Cath Lab Digest

We will continue with the SFA this month. Clearly, this is a story that continues to write itself. Dr. Saxon presented the VIPER study at the VIVA 2011 conference in Las Vegas this year. The results are intriguing in several ways. For one, the trial was similar to the VIBRANT study using the Gore Viabahn (W. L. Gore & Associates) endoprosthesis treating a great 20 cm lesion length with nearly 60% being totally occluded. Unlike VIBRANT, the primary patency was an extremely respectable 74% using the metric of 2.5 PSVR.

In addition, when reviewing the last 3 seminal trials, RESILIENT, ZILVER PTX and now VIPER, we see that stents on a short lesion length (RESILIENT and ZILVER) do very well with the drug adding a modest 4% or so to the primary patency. Now we can see in VIPER that with an endoprosthesis, primary patency on the most difficult lesion seen on a daily basis is over 74%; this 10% difference to the primary (first cut) patency of ZILVER is remarkable.  

The safety of the endoprosthesis seems acceptable and there were no increased stent thromboses. Further, because of the lack of thromboses, we also see that the covering of the distal collateral bed may not be as catastrophic as many had thought.

If we believe this device works for the worst of the worst, we can surmise that the endoprosthesis would be very good for the short (trial type) lesion subset as well.

It may now be worthwhile to do what we in science have advocated for a long time and that is a head to head comparison with the same PSVR metric and test the short, medium, and long lesions with several devices. We can even add angioplasty to the mix. In this way we can begin to finally determine which device is “best” for a certain subset of patients and for those more challenging patients. Critically, without these types of trials, we will continue to be relegated to the thought “we believe” rather than “we know.”

I believe we are seeing a true emergence of some “science” in this anatomic territory that has long been lacking. What this “data” mean for the future in my mind is that all devices—stents, balloons, drug-coated balloons, and importantly, alternative therapies with debulking, will have a “higher” bar to meet before tacit approval from the scientific community is given and before acceptance over current stent technology as the default therapy for many, if not all, lesions, is supplanted.  

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Dr. Garcia received his B.A. and M.D. degrees from the University of Arizona. He was an intern and resident at Parkland Memorial Hospital, University of Texas at Southwestern in Dallas, Texas. He received his training in cardiology at the University of Iowa Hospitals and Clinics in Iowa City, Iowa, and as an interventional cardiologist at the Beth Israel Deaconess Medical Center, Harvard Medical School. Further, he received his peripheral vascular training at St. Elizabeth’s Medical Center, Tuft’s University, Boston, Massachusetts. He then served as the Chief of Vascular Medicine and Peripheral Vascular Interventions for the Florida Heart Group in Orlando, Florida. Dr. Garcia returned to Harvard’s Beth Israel Hospital as a full-time interventional cardiologist and Director of the Peripheral Cardiovascular Program and Peripheral Interventions at the Beth Israel Deaconess Medical Center as well as the Director of the Interventional Fellowship Program. This program developed into one of the busiest in the city of Boston, performing over 600 peripheral procedures per year.

Dr. Garcia has now returned to St. Elizabeth’s Medical Center as Chief of the Section of Interventional Cardiology and as Associate Director of the Vascular Medicine Program. Dr. Garcia’s work has largely focused on arterial occlusion-reperfusion models and the efficacy of therapeutic modalities or interventions with regard to free radical generation or endovascular stenting outcomes. Dr. Garcia continues his research interests in a wide variety of studies including acute MI studies, unstable angina studies, interventional trials, peripheral interventional trials, angiogenesis trials, imaging modality studies, and numerous device trials for both the coronary and peripheral circulations. His work has been presented in numerous manuscripts, abstracts, textbooks and textbook chapters.