Cath Lab Digest

This month we will continue to evaluate the SFA conundrum — lack of meaningful scientific and real-world data but with robust technology all on the sidelines touting great successes. Let’s review:

First, angioplasty seems to trump best medical therapy and exercise in the MIMIC trial. This statement stems from a small European study looking at both iliac and SFA lesions. However, despite the low numbers and lack of directed anatomic information (i.e., overall lesion length, etc.), the outcomes based purely on objective measures, walking distance, etc. all favored intervention.

Second, we have seen that angioplasty does not perform as well as stenting in several trials including the ABSOLUTE and RESILIENT trials. These trials either by design or by outcome proved angioplasty is less durable in the first year compared with stenting. We have reviewed the caveats to these trials and their outcomes for our patients with long lesions that I believe warrant further analysis and better studies.

Third, we have reviewed the data from drug-eluting stents from SCIROCCO to ZILVER PTX showing the mixed bag of results from drug elution compared with bare metal stenting technology. Currently, the ZILVER data suggest the absolute benefit and durability out to 2 years for a non-polymer coated stent platform in the treatment of short SFA lesions. There have been important signals in the registry for Zilver regarding longer lesions. However, no trial to date is directed at the longer lesions we see in our practices. Further, the conundrum of “optimal” PTA in the Zilver trial suggests a stent-like outcome for angioplasty compared with other stent trials needs to be evaluated or assessed further with a trial by design to evaluate optimal angioplasty to an endoprosthesis.

Lastly, we have seen that the drug-eluting data seem compelling in the setting of SFA disease either in the short or medium lengths and in both the short and long term for durability. There have been glimmers of the “optimal” balloon result in the THUNDER and LEVANT trials suggesting that it may be secondarily benefited from the addition of drug transfer to the balloon technology. Further, we have several ongoing device companies vying for this seemingly coveted area of SFA intervention.

What we can understand from this review is that the SFA, in of all its presentations of disease from occlusive to stenosis, short to long, and noncalcified to exophytic, remains an open book from where we start with a device to what we finally choose for revascularization strategy to what will be the “workhorse” in our real world patients.

Next month, I would like to go over the data regarding the DEB’s from Europe and look closely at 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.