What is the best therapy when we compare current data for revascularization of the SFA?

First, let us discuss angioplasty from the Mild to Moderate Intermittent Claudication (MIMIC) trials (ie, overall lesion length unknown or not documented in both the iliac and SFA). The outcomes were based purely on objective measures, walking distance, etc. and all favored intervention compared with walking programs alone. This is probably in line with the CLEVER trial that seemed to suggest that the best medicines trumped intervention, but this was not consistent throughout the cohort.

Second, we have seen that angioplasty does not perform as well as stenting in several trials, including the ABSOLUTE and RESILIENT. Despite the fact that in some of the trials angioplasty was set for failure in the design of the study using their outcomes as a pure number, we see that in lesions up to 10 cm as with ABSOLUTE and at 6 cm in RESILIENT, our outcomes are either 63% or 80%, respectively.

Third, in reviewing the current DES stent data we can primarily focus on ZILVER PTX. In this seminal randomized trial, at only 53 mm in the randomized portion of the trial, the full cohort endpoint was about 77% at 1 year. Further, the registry data using a different PSVR suggest that in longer lesions, the DES continued to perform very well.

Lastly, the drug-coated balloon technology, THUNDER and LEVANT, have suggested that the “optimal” balloon result using a drug coating improves the angioplasty outcome to near 80% primary patency in lesions at 7.4 cm and 8.1 cm, respectively.

In combining this series of data, DES gets us to near 80% and non-coated stents have a similar outcome metric. Further, best balloon therapy with drug coating has a similar outcome. What we do not currently know is how directional atherectomy will affect the outcomes. We will, however, have some information about this in the near future with the DEFINITIVE LE trial for which I serve as one of the global PIs. When our data set is fully presented this year we will see where plaque excision compares with the above data for a primary patency outcome at 12 months with the short, medium, and long lesions.

Now the ultimate question is, “What is the best therapy for the data as we have it?” Our biggest issue will remain; “Does a stent trump the outcome of other technologies?” Does it require first, a leave nothing behind approach to lead to stenting later if restenosis occurs? I cannot believe that our up-front strategy would be that any stent failure is better than a non-stent failure when it comes to retreatment and that we would allow less than all treatment options for the repeat procedure. Please let me know what you think.

______________________________________________________________________________

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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What is the best therapy when we compare current data for revascularization of the SFA?

First, let us discuss angioplasty from the Mild to Moderate Intermittent Claudication (MIMIC) trials (ie, overall lesion length unknown or not documented in both the iliac and SFA). The outcomes were based purely on objective measures, walking distance, etc. and all favored intervention compared with walking programs alone. This is probably in line with the CLEVER trial that seemed to suggest that the best medicines trumped intervention, but this was not consistent throughout the cohort.

Second, we have seen that angioplasty does not perform as well as stenting in several trials, including the ABSOLUTE and RESILIENT. Despite the fact that in some of the trials angioplasty was set for failure in the design of the study using their outcomes as a pure number, we see that in lesions up to 10 cm as with ABSOLUTE and at 6 cm in RESILIENT, our outcomes are either 63% or 80%, respectively.

Third, in reviewing the current DES stent data we can primarily focus on ZILVER PTX. In this seminal randomized trial, at only 53 mm in the randomized portion of the trial, the full cohort endpoint was about 77% at 1 year. Further, the registry data using a different PSVR suggest that in longer lesions, the DES continued to perform very well.

Lastly, the drug-coated balloon technology, THUNDER and LEVANT, have suggested that the “optimal” balloon result using a drug coating improves the angioplasty outcome to near 80% primary patency in lesions at 7.4 cm and 8.1 cm, respectively.

In combining this series of data, DES gets us to near 80% and non-coated stents have a similar outcome metric. Further, best balloon therapy with drug coating has a similar outcome. What we do not currently know is how directional atherectomy will affect the outcomes. We will, however, have some information about this in the near future with the DEFINITIVE LE trial for which I serve as one of the global PIs. When our data set is fully presented this year we will see where plaque excision compares with the above data for a primary patency outcome at 12 months with the short, medium, and long lesions.

Now the ultimate question is, “What is the best therapy for the data as we have it?” Our biggest issue will remain; “Does a stent trump the outcome of other technologies?” Does it require first, a leave nothing behind approach to lead to stenting later if restenosis occurs? I cannot believe that our up-front strategy would be that any stent failure is better than a non-stent failure when it comes to retreatment and that we would allow less than all treatment options for the repeat procedure. Please let me know what you think.

______________________________________________________________________________

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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