The SFA School of Thought Continues
We will continue with the SFA this month. Clearly, this is a story that continues to write itself. Dr. Saxon presented the VIPER study at the VIVA 2011 conference in Las Vegas this year. The results are intriguing in several ways. For one, the trial was similar to the VIBRANT study using the Gore Viabahn (W. L. Gore & Associates) endoprosthesis treating a great 20 cm lesion length with nearly 60% being totally occluded. Unlike VIBRANT, the primary patency was an extremely respectable 74% using the metric of 2.5 PSVR.
Evaluating the SFA Conundrum
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.
A Review Of Drug-Eluting Technologies in SFA
This month I wanted to review the last area that we have not fully reviewed as of yet—drug-eluting technologies in the superficial femoral arteries (SFA). To date we have seen just the glimmer of data from the balloon technologies that have additional drugs added in the SFA.
The Truly Untested Modality: Drug Elution
For this month, I would like to look to a new direction for the SFA and that is drug elution. We have discussed the current technology from balloon angioplasty to stenting to debulking. Drug elution remains an intriguing, though as of yet, truly untested modality that leads one to contemplate each modality on its merits.
Shedding Light with Single-Center Case Studies
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.
SFA Data Boosted from Zilver Trial at SCAI Meeting
The superficial femoral artery (SFA) data got another boost from the Zilver trial (Cook Medical, Bloomington, Indiana) this past month. The data presented at the SCAI meeting showed continued patency of the stented segments at 24 months compared with the percutaneous transluminal angioplasty (PTA) arm. At 12 months we recall that the Zilver result had a primary patency of 83% to 78% depending on the hard 12-month or 13-month endpoint. The optimal PTA had a primary patency of 64% in that time period.
Head-to-Head Trial Needed to Answer Long SFA Lesion Question
This month we will continue to discuss the superficial femoral artery (SFA) and the data we have thus far. My question this month focuses on data from two previous trials. The RESILIENT lesion data at 5.7 cm (stented length > 6 cm) and the ZILVER PTX lesion data at 5.3 cm (stented > 6 cm) showed patencies of 80% and 84–78% (depending on outcome month), respectively. What, then, is the benefit of the paclitaxel on these outcomes? Moreover, is the stenting arm achieving optimal outcomes at 80% patency?
Slow Road to Clear Data on SFA Interventions
Let us continue down the road of the superficial femoral artery (SFA). Clearly, the data stream is slow and steady, but unfortunately, there continues to be a paucity of robust real-world data. The 2-year data for the Zilver PTX peripheral stent (Cook Medical) were presented at ISET and LINC. Michael Dake and his co-investigators should be commended on a great job with the study.
Optimal Balloon Angioplasty vs. Stenting for SFA Lesions Up to 20 cm
To continue on the SFA trail, I would like to ask: How many of us would be willing to randomize a patient to “optimal” balloon angioplasty in a head-to-head comparison with other devices for a lesion length of up to 20 cm? Although the answer for many is unequivocally, “never”, many others may suggest that a “coin-flip” approach with an endoprosthesis (stent) is not much better. I don’t know the answer to the question, but I need to get an idea about where we as “plumbers” with the “best” interest of our patients at heart fall on the issue.
