Cath Lab Digest

The continued blurry vision of the “data” regarding the superficial femoral artery (SFA) is at least somewhat clearer. Several studies now have good scientific data (core lab-adjudicated and multicentered data) behind them. The overall issue with regard to the SFA remains that most trials to date have been relegated to “getting an indication” and not to what we see in the “real world”. Of interest from the recent trials we have reviewed and examined, only the VIBRANT data were performed on lesions > 10 cm. In fact, this trial dealt with lesions that averaged 20 cm. All other data, ABSOLUTE (10.3 cm), RESILIENT (5.7 cm), and ZILVER (5.3 cm) have been far less. In fact, to look at other devices: cryoplasty (just over 4 cm), Pathway (European data – 4.1cm), OASIS (orbital atherectomy – 3.1cm), which have not faired any better. Currently, the DEFINITIVE trial from eV3, Inc., for which I am one of three global primary investigators, has just announced the 6-month data for lesions that average just under 8 cm for the entire cohort of patients for both the SFA/popliteal and infrapopliteal segments. The cohort-specific lesions in the SFA ranged from small (4 cm in 50% of the subjects), to medium (4–10 cm in 30% of the subjects), to large (> 10 cm 20% of the subjects).

The difficulty in the current environment is the continued pressure to “get the indication” for the device, then get the “real data” — which is troubling and needs reassessment. The current data set would be similar to a coronary trial testing a stent in a target lesion of 15 mm, but testing only 5–6 mm. It seems a bit of a stretch to then suggest the absolute benefit of the device in the patients we treat everyday. What would the potential be for a “real-world” head-to-head study testing all major modalities in lesions up to 20 cm in length? Wouldn’t that be fantastic? Could it be done?

Let’s see where the discussion goes from here and pick it up next month.

____________________________________________________________________________________________

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.