“We’re living in a new world order” when it comes to “no-option” chronic limb-threatening ischaemia (CLTI) patients, says Anahita Dua (Massachusetts General Hospital, Boston, USA). In recent years, into this arena has stepped transcatheter arterialisation of the deep veins (TADV), raising hopes of reducing amputation rates amid a rise in diabetes and other disease affecting microvascular dissemination. At the 2025 Vascular Annual Meeting (VAM; 4–7 June, New Orleans, USA), Dua put forward data from a new study comparing no-option CLTI patients enrolled in the PROMISE studies treated with TADV to a CLariTI study cohort who were treated using standard of care (SoC). So, “is TADV worth it?” she pondered. The one-year comparative data she presented seemed to provide an answer in the affirmative.
Positive PROMISE I and II data have seen TADV, also known as deep vein arterialization (DVA), gain traction, Dua told VAM 2025, but the “real question remains,” she said. “If you’re going to do a [TADV] procedure on a patient, then go forward with all the wound care, all the phone calls, and all the pain for the next six months to try to salvage the limb, does it really lead to better wound healing, better limb salvage rates and better amputation-free survival?”
With no randomised clinical trial data to call upon in the space to measure a difference between TADV and standard of care, Dua and colleagues compared the combined patient groups from PROMISE I and II to the real-world CLariTI group to “see whether or not limb salvage rates genuinely decrease” when the former modality is deployed.
“We did CLariTI after PROMISE, so we were able to design the study to match the PROMISE studies so that we could ensure we had matching across groups,” she explained. “As you can see, most importantly this is, again, a real-world study, with a significant number who were Black or African American, had Rutherford 5/6, and a significant history of CKD [chronic kidney disease].”
The data showed limb salvage rates of 82.2% vs. 51.3% in the TADV/ PROMISE I/II group and CLariTI, respectively; and amputation-free survival (AFS) rates of 71% for TADV vs. 34.1% for standard of care.
“For wound healing, 78% of patients at one year were either fully healed or healing in the DVA group versus the standard of care,” said Dua. “Going out, because durability matters, in the patient cohort for CLariTI—we are still collecting our data, because that was after the PROMISE study—but for the PROMISE data, we are at two years now and the limb salvage rate is still at 68%, which is excellent compared, already, to the 51% at one year for the standard of care.”
Overall, Dua concluded, “I think the data is relatively clear. Even though we don’t have an RCT, we have an excellent matched set from CLariTI compared to patients that have DVA and it is clear that DVA does have clinical benefit in patients selected appropriately. These benefits are consistent, especially if you use the LimFlow system [Inari Medical], which is kind of like the TCAR [transcarotid artery revascularisation] of the leg in that you are able to do the same thing every time. The off-the-shelf DVA that exist—and the data around that—is very variable so that is not included in any of this.”
