| Institution: | 1. Department of Radiology and Biomedical Imaging, University of California, San Francisco, 505 Parnassus Avenue, M-361, San Francisco, CA 94143;2. Division of Angiology, Medical University, Graz, Austria;3. Angiology Department, Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany;4. Cardiology Department, Humanitas Gavazzeni Hospital, Bergamo, Italy;5. Division of Angiology, University Hospital of Bern Inselspital, University of Bern, Bern, Switzerland;6. Aortic, Peripheral and Venous Department, Medtronic, Santa Rosa, California;7. Aortic, Peripheral and Venous Department, Medtronic, Plymouth, Minnesota;8. St. Joseph Heart and Vascular Center, Orange, California |
| Abstract: | PurposeTo 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).Materials and MethodsA 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]).ResultsIn 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.ConclusionsIn 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. |
