Cath Lab Digest

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? Recall the outcome on the longer lesion lengths tested: the Schillinger et al result at 10.1 cm was 63% patency at 1 year and 54% patency at 2 years, and VIBRANT achieved a 53% primary patency at 1 year at 20 cm lesion lengths. Does the metric of the VIVA OPC still hold true that we should aim for 66% patency for lesions of 4–15 cm in future trials? I believe this data set, good scientific data, suggest that we may not know the correct answer for long, typical lesions in the SFA. Further, I believe this lack of compelling data remains the reason alternative therapies remain in the mix for treatment strategies. It may be very intriguing to see if the drug-eluting balloon can live up to its hype in a controlled study in this country. Further, the combination of debulking with an anti-restenosis treatment, either with a balloon or an endoprosthesis, appears intriguing. One trial for which I serve as a national PI with my colleague, Jim McKinsey, from Columbia-Presbyterian is the DEFINITIVE-LE, is nearing completion. The up-to-date 6-month data for this trial were presented at VIVA in 2010 and will continue to be presented throughout the year. Its final 1-year data will likely be presented in 2012. What we really need, as I have stated before, is a complete head-to-head trial involving the major therapies: PTA, stenting, covered stenting, drug-eluting therapy (balloon and stent), and debulking therapies — all tested in real-world patients. We may find that the outcomes are still not optimal for most of our patients. Let’s discuss this further next month.