Medtronic’s In.Pact Admiral DCB Assessed for In-Stent Restenosis of the Femoral-Popliteal Artery in SVS VQI Registry-Based Study

November 4, 2022—A prospective, single-arm, registry-based study conducted by the Society for Vascular Surgery (SVS) Vascular Quality Initiative evaluated the safety and performance of the In.Pact Admiral paclitaxel drug-coated balloon (DCB; Medtronic) for treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR).

The study included 43 sites across the United States and evaluated 300 patients. Clinical outcomes were assessed at 12, 24, and 36 months.

Daniel J. Bertges, MD, presented the study during the third of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

As reported in the VIVA Foundation press release, the primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints included technical success, target vessel revascularization (TVR), major limb amputation, and all-cause mortality.

Patients were typical of the peripheral artery disease population, with a mean age of 68 years, 58% male, and 56% with diabetes. The majority of patients had claudication (80% Rutherford class 2-3), while 20% had ischemic rest pain (Rutherford class 4). Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. Mean lesion length was 17.8 ± 11.8 cm.

Occlusions were treated in 43% of lesions (mean occluded length, 16 ± 10 cm). Type by TransAtlantic Inter-Society Consensus (TASC) included: TASC A, 17%, TASC B, 29%; TASC C, 38%; and TASC D, 15%.

Based on interim Kaplan-Meier estimates at 12 and 24 months, Dr. Bertges reported the following at VIVA22:

• Freedom from any TLR was 90% and 72%.
• Freedom from any TVR was 88% and 68%.
• Freedom from major target limb amputation was 99% and 99%.
• All-cause survival was 95% and 89%.

In this postmarket registry-based study, Dr. Bertges noted that the In.Pact Admiral paclitaxel DCB shows promising results in treating femoropopliteal ISR with freedom from TLR of 90% at 1 year.

These results demonstrate the ability of the SVS VQI to conduct postmarket evaluation of peripheral devices in partnership with industry and federal regulators, concluded the VIVA Foundation press release.