Cath Lab Digest

I will continue this theme of evidence-based medicine for lower extremity revascularization in patients with claudication and critical limb ischemia and focus on the treatment of the superficial femoral artery (SFA) for claudicative diseases in the continued hopes of driving a robust conversation.

I had the great privilege of debating the question of evidence and costs of trials at the CRT meetings this past month in Washington. I had the unenviable position to defend “we know the answers, save your money!” when it came to trial design in the SFA. This topic at face value is not something I thought I could defend, however, in the “spirit” of the defense, I did. I must say that in a robust review of the currently available data, it was very easy to defend that “going for an indication” is clearly different than “what is best evidence for “real-world” patients”. I cannot believe that a trial of 6.4 cm (as was the RESILIENT trial) is a robust study to translate to the general population and that an 80% patency there would translate to something similar in general practice. Clearly, there remains a disconnect between trial design and real-world populations. Understanding the need to start somewhere is important, but the need for the cohort to represent more of the general population is equally important.

Should we accept the meager data from the SFA trials and infer the data to the real world with reckless abandon? How do we get started and how do we engender meaningful data in this very difficult territory?

Let’s see where this discussion leads and reconvene next month.

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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.