Data Available on Superficial Femoral Artery Revascularization
This month, I’d like to continue the discussion of superficial femoral artery (SFA) data and the trials we have at our disposal to make informed decisions regarding revascularization and durability with several types of technologies. The release of the IN.PACT study from Medtronic at Charing Cross this past month is an important additional piece of the SFA conundrum.
For review, the data released showed that on a nearly 9 cm metric in the SFA of a total of 220 DCB patients with around 30% CTOs and primarily in de novo lesions (95%) using a PSVR of <2.4 revealed a primary patency of nearly 90%. Why is this important? Because for the first time we now have a “nearly real world” experience that has achieved a primary patency in the “holy-grail” range of 90%. This critical finding is so important on several fronts. First, the stenting rate was under 5% so this is truly a leave nothing behind study. Second the outcome is better than a similarly delivered drug on an endoprosthesis on a shorter lesion length and better than a similar length on a BMS stent study. Lastly, the approach of balloon only allows for a failure mode that affords all other therapies without a significant downside particularly if the failure mode (restenosis) is either diffuse or focal.
In the greater landscape the findings from Medtronic have got to look good for all plumbers in the world. Particularly, since we still have not mastered how to treat this difficult region of the SFA. Further, the principal idea that leaving nothing behind allows further therapy without the additional need for atheroablative technologies prior to further “definitive” therapy for failed endovascular prosthesis is I would argue a cost effective “winner” for both the health care system and patient.
This study is critical to the current landscape and we must now move forward with direct comparative trials to test which device works and “wins” for our patients is absolutely needed at this time.
Let me know what you think.
