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More on the SFA Data Discussion

  • Wed, 5/5/10 - 10:38am
  • 2508 reads
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Continuing the discussion regarding superficial femoral artery (SFA) revascularization from last month, we had a couple of responses that centered on the fact that the “data” remain scant and the likelihood of long-term benefit would favor surgical revascularization. So to be controversial and challenging…

Given that, I believe, we cannot compare the surgical data to endovascular data currently because we do not have the apples-to-apples comparisons either from the endovascular group being less sick according to the surgical view, or because the surgical lesion types are ill-defined from the endovascular view. Of equal importance, but less thoroughly discussed, are the longer-term data beyond the first year for stents. Looking at the Schllinger et al ABSOLUTE 2-year data (Circulation 2007), we can see a further decline in primary patency in stents to the order of 54%. If we accept this number, in general, then what is painful but important is that there is less overall benefit to stenting in the SFA beyond 2 years compared with simple angioplasty alone from an anatomic standpoint. Indeed, for “real-world” type lesions beyond 10 cm, as in VIBRANT, the primary first-year patency remains low at 53%. However, the clinical benefit for many, if not most, claudicative patients is that despite restenosis or frank occlusion, many patients feel clinically improved after the endovascular repair, supported by a similar walking test in the ABSOLUTE 2-year manuscript.

What does this mean and how can we then compare primary patency with the clinical benefit of the procedure? This conundrum is what the FDA has been wrestling with for the past few years. Where does a revascularization strategy benefit end — on clinical or anatomic grounds? If we continue with the fact that the primary patency of surgical autologous grafts for above-knee bypasses includes around a 10–15% revision rate, the surgical data seem less robust.

This controversy is an important one. 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.

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