Cath Lab Digest

For this month, I would like to look to a new direction for the SFA and that is drug elution. We have discussed the current technology from balloon angioplasty to stenting to debulking. Drug elution remains an intriguing, though as of yet, truly untested modality that leads one to contemplate each modality on its merits. As it currently stands the U.S. has no current drug-eluting technology for the periphery whereas in Europe they have several different companies currently available. We have seen a few trials, THUNDER, FEM-PAC, and LEVANT 1—all driven from the European theater with average lesion lengths of 4.1, 7.4, and 8.1 cm, respectively. Why do our patients remain at risk when there may be a benefit from a non-endoprosthesis approach for the SFA?

These questions raise the issue about the road to indication in this country. Currently with the standards as they are set, we will need to have a randomized trial that can piggyback on the European data to suffice for a complete trial data set. Then, we wait for the approval process to eventually have the devices available in 3–4 years, which will then be about 5–6 years from their European introduction. Does anyone else feel that we have lost our way with the innovative process in this country? I am not an advocate of accepting the data as dogma because the small series data seem compelling but I am asking, why should we be so far behind the innovative curve at this critical time in science?

Could we agree that for the scientific pursuits we use the data set provided from our European colleagues and begin a robust trial in the U.S. with any or all (currently 3 device companies for the U.S.) devices to come to an answer regarding these devices? We may find that they do not trump a stent (given the Zilver PTX data) (Cook Medical, Bloomington, Indiana) or they may prove to be just as good as they have been touted.

Next month, I would like to go over the data regarding the DEB’s from Europe and look closely on the potential scientific outcomes that may help us decide where they may fit into our armamentarium to use for our patients suffering from symptomatic peripheral vascular disease. 

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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.