Cath Lab Digest

I saw a single-center study presentation recently at a meeting where one of our colleagues shared their “data” regarding the superficial femoral artery (SFA) and restenosis. Here are the main points: the patient population was made up of in-stent restenosis patients with a lesion length of 27 cm. These were treated with another stent of different design and this presenter showed their 1- and 3-year outcomes based on duplex criteria. The results: primary patency at 1 year was a miraculous 87% and at 3 years, the decline in patency was to an astounding 85%. Does anyone in this world or in this universe believe these data? If you do, please enlighten me as to the way this data is “real” when compared to the direct randomized or even registry data seen time and again. Even if this type of data were true, the fact remains that in the presented literature, a lesion length of 20 cm has a primary patency of 53% with a covered stent and 58% with an open cell design. Further, the registry data regarding drug-eluting balloons at an 11 cm lesion length is 70% and for in-stent restenosis of 15 cm, 80%. One journal editor had a recent editorial titled “Beware the Stupids” and I must agree that we, as scientists, must be proactive in challenging ourselves to prove the data we present.

There remains a paucity of the data for the SFA and unfortunately, we have not made serious attempts to clear this up to any great degree. For a short lesion, I suspect most of us would default to a balloon and initial therapy. The primary patency with short lesions from Zilver (Cook Medical, Bloomington, Indiana) with optimal results was 64%. Further, for the TASC B lesions ≥ 10 cm, I would argue that most would accept stenting as the default answer, with the proviso that repeat intervention would be likely in the next 1–2 years¹—though I bet many of us do not discuss this problem of restenosis with our patients and the lack of any meaningful data for this lesion length. How could we — or how do they — understand the subtleties on outcome measures? For those difficult lesions of over 10 cm to 20 and 30 cm, we have little to no data. Do stents trump the outcome of drug-eluting balloons? It’s hard to know. How do alternative therapies play in this territory? Clearly, data are scarce; however, the DEFINITIVE² trial recently completed its enrollment and the outcome measures on patency and other secondary end points may shed some light on whether this type of revascularization is a reasonable approach.

What may ultimately be interesting is what to make of the long total occlusion and the need for revascularization. What therapy and what metric on outcomes are important? Does clinical patency trump the anatomic? Clearly, or less clearly, will be how a single center’s study plays into our decisions. Good single-center studies may shed a glimmer of light into a world that no industry will entertain, as the outcome of such a study is either too difficult to prove or will only prove futility. To that end, our colleague’s single-center data of amazing results, albeit unlikely to be at all true, may be the nidus to truly study the outcome that we scientists need.

References

1. Schillinger M, Sabeti S, Loewe C. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 2006 May 4;354(18):1879-1888.
2. http://clinicaltrials.gov

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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.