Real-world outcomes of endovascular treatment in a non-selected population with peripheral artery disease - prospective study with 2-year follow-up

Background: The study aimed to evaluate the outcomes of percutaneous transluminal angioplasty (PTA) in lower-extremity peripheral artery disease (PAD) patients. Patients and methods: A multi-centre, observational study was performed with 32 German and Austrian centres contributing data to the PTA registry. Data of 1,781 patients with lower-leg and pelvic PAD who were suitable for endovascular PTA treatment were contributed from participating centres. Data from 1,533 patients are reported here (1,055 male and 478 female). This study did not have exclusion criteria. Quality of life (QOL) questionnaire (EQ-5D) scores, Rutherford classification, mortality, patency rate and details of major adverse cardiovascular events were collected at 6-, 12-, 18-, and 24-month follow ups. Results: PTA with/without stenting achieved 90.3 %, 86.5 %, 82.7 %, and 71.9 % technical success (recanalisation achieving ≥ 70 % patency, no evidence of embolisation, recoiling or dissection) in iliac, femoral, popliteal, and below-the-knee arteries, respectively. Procedural/postprocedural complications occurred in 142 (9.3 %, 1 death) and 74 (4.8 %) patients. QOL, mobility, self-care, activity, and pain/discomfort scores improved (p < 0.01), anxiety/depression was insignificantly improved. During follow-up, 409 (26.7 %) patients were hospitalised for PAD, 281 (18.3 %) required reintervention, and 145 (9.5 %) died or needed amputation (n = 49; 3.2 %). Multivariate analysis demonstrated poorer outcomes in patients with comorbidities. Conclusions: PTA with/without stenting is effective, safe, and widely applicable, with few complications. It improves QOL, but not anxiety/depression.