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Kohi, MP; Brodmann, M; Zeller, T; Micari, A; Baumgartner, I; Wang, H; Wall, B; Razavi, MK.
Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis.
J Vasc Interv Radiol. 2020; 31(9):1410-1418 Doi: 10.1016/j.jvir.2020.05.012 [OPEN ACCESS]
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Co-authors Med Uni Graz: Brodmann Marianne
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Abstract:: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men. Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.
Find related publications in this database (using NLM MeSH Indexing): Age Factors -; Aged -; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Disease Progression -; Female -; Femoral Artery - diagnostic imaging; Femoral Artery - physiopathology; Health Status Disparities -; Humans -; Male -; Middle Aged -; Peripheral Arterial Disease - diagnostic imaging; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - therapy; Popliteal Artery - diagnostic imaging; Popliteal Artery - physiopathology; Prospective Studies -; Risk Factors -; Sex Factors -; Single-Blind Method -; Time Factors -; Treatment Outcome -; Vascular Access Devices -; Vascular Patency -