Cath Lab Digest

As we continue to dissect the data and science for lower-extremity revascularization, do you think it possible to obtain “real-world” data in a scientific way? This question is critical as we see many “registries” comparing to potentially FDA-mandated optimal performance criteria (OPC). The FDA has accepted as “de facto” the OPC (Rocha-Singh CCI 2007) as the metric for all things SFA. How do we obtain reasonable data for “real-world” patients? What is critical in my read of the OPC is that it is based on only 6 good trials both by industry and by single centers where randomization between a stent arm and angioplasty occurred. The OPC suggests a “goal” for patency up to a lesion length of 14 cm and does not apply to lesions above this (i.e., the performance goal at 18 cm is unknown). This manuscript, which was an outstanding compilation from my colleagues and authors, had to deal with competing sources to combine several trials to obtain their final suggested goal. The goal was intuitive, with little statistical or scientific direction. However, looking at the current data from reasonable trials (Schillinger, NEJM), it appears to hold up. The problem remains that after its acceptance, many trials, with the exception of VIBRANT, have ended up looking at lesions far shorter than 14 cm.

The question is: Can we as a group enter patients into a real-world registry or, more importantly, randomization to lesions over 6 cm and under 20 cm? Would the scientific community randomize patients to an angioplasty arm in such a trial? Would we be willing to take the time for optimal angioplasty in longer lesions — knowing for a fact that the PTA arm is less patent at 1 year, but not very different clinically for walking tests at 18–24 months (Schillinger Circ 2008)? If such a trial existed, would all endovascular “plumbers” be willing to enroll patients? Would our surgical colleagues be willing to participate? Lastly, should we not have a medical treatment arm as well? Ultimately, the major question is where and how do we fund such a trial? Industry is the least likely to push this envelope and governmental funds usually take a lot longer to secure.

Look this over and tell me where we should go, where I am misinformed, or just wrong. I look forward to the discussion.

Lawrence A. Garcia, MD

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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.