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Outcomes Following Drug-coated Balloons And Drug-eluting Stents In Patients With PAD
Jeremy D. Darling, MD, MS, Camila R. Guetter, MD, MPH, Elisa Caron, MD, Jemin Park, MD, Isa F. van Galen, MD, Patric Liang, MD, Lars Stangenberg, MD, PhD, Allen D. Hamdan, MD, Mark C. Wyers, MD, Marc L. Schermerhorn, MD.
Beth Israel Deaconess Medical Center, Boston, MA, USA.
OBJECTIVES: Drug-coated balloons and drug-eluting stents (DCB/DES) have shown promise in improving outcomes for patients with peripheral artery disease (PAD), however, more real-world analyses are needed to better understand the role of this technology within current practice. As such, we compared our institution’s experience with DCB/DES versus percutaneous transluminal angioplasty +/- stenting (PTA/S) for the treatment of PAD.
METHODS: All patients undergoing an infra-inguinal endovascular intervention for PAD at our institution between 2016 to 2022 were retrospectively reviewed. Patients undergoing isolated supra-inguinal or tibial interventions were excluded. Primary outcomes included patency, freedom from major adverse limb events (MALE), limb salvage, and amputation-free survival (AFS). To account for baseline differences, one-to-one propensity score matching was performed between DCB/DES and PTA/S groups. Outcomes were further evaluated using chi-squared tests and Kaplan-Meier analyses.
RESULTS: Between 2016 and 2022, 802 patients underwent an endovascular infra-inguinal intervention for PAD: 216 DCB/DES and 576 PTA/S. After matching, 205 patients were included in each group. DCB/DES and PTA/S patients were commonly male (51% vs. 53%), white (71% vs. 73%), and diabetic (63% vs. 67%), with 44% and 46% presenting with claudication, respectively (all p>.05). Kaplan-Meier analyses demonstrated higher one-year rates of primary patency in the DCB/DES group (85% vs 73%; p=.01), however, this difference was not seen at three years (59% vs. 56%; p=.09). Further, DCB/DES had a higher freedom from MALE (three-year rates: 85% vs 78%; p<.01), correlating with a 38% reduction in events (HR 0.62, 95% CI [0.39-0.99]). There were no differences noted in rates of limb salvage (three-year rates: 94% vs. 94%, p=.67) or AFS (three-year rates: 77% vs. 75%; p=.36). When stratifying by indication, DCB/DES demonstrated a higher freedom from MALE among patients with CLTI (three-year rates: 84% vs. 68%; p=.04), but not among claudicants (88% vs. 85%; p=.28) (Figure I).
CONCLUSIONS: Despite only demonstrating a transient short-term benefit in primary patency, our matched cohort of DCB/DES did exhibit a significantly higher freedom from MALE, as compared to PTA/S. This effect was most notable in patients with CLTI. These data demonstrate the importance of further analyses on this evolving technology.
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