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A Registry-based Study of Paclitaxel Drug-coated Balloon Angioplasty for the Treatment of In-stent Restenosis of the Femoral-popliteal Artery
Daniel J. Bertges, MD1, Jens Eldrup-Jorgensen, MD2, Rabih A. Chaer, MD3, Michael C. Stoner, MD4, Luke K. Marone, MD5, Kristina A. Giles, MD2, Brian G. DeRubertis, MD6, Glenn R. Jacobowitz, MD7, Jack L. Cronenwett, MD8.
1University of Vermont Medical Center, Burlington, VT, USA, 2Maine Medical Center, Portland, ME, USA, 3University of Pittsburgh Medical Center, Pittsburgh, PA, USA, 4University of Rochester Medical Center, Rochester, NY, USA, 5Penn Highlands Vascular Surgery, Monongahela, PA, USA, 6Weill Cornell Medicine, Burlington, VT, USA, 7New York University Langone Health, New York, NY, USA, 8Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.

Objective To report results of a prospective, single-arm, registry-based study assessing the safety and performance of paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery ISR in a United States population.
Methods We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for treatment of ISR lesions in the SFA/popliteal artery at 50 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016-January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. 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. Results are presented as survival probabilities based on Kaplan-Meier survival estimates.
Results Patients (N=300) were 58% male with mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Occlusions were treated in 43% (mean occluded length 16 ± 10 cm). TASC type was 17% A, 29% B, 38% C, and 15% D. Technical success was 99% (Table). Re-stenting was used in 5% and thrombolysis in 0.6% of procedures. Based on Kaplan-Meier estimates freedom from TLR was 90%, 73% and 62% at 12-, 24- and 36 months (Figure). Freedom from TVR was 88%, 69% and
59%. Freedom from major target limb amputation was 99% at 12-, 24 and 36-months. Survival was 95%, 89% and 84% at 12-, 24- and 36 months.
Conclusion This post-market registry-based study of a paclitaxel DCB shows promising results in treating femoral-popliteal ISR with freedom from TLR of 90%, 73% and 62% at 12-, 24- and 36 months. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

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