The START-SIAPAV-PAD Registry – Rationale, study design, and baseline characteristics of an ongoing Italian multicentre registry

Summary: Background: Peripheral artery disease (PAD) is associated with a high burden of cardiovascular and limb events, yet guideline-directed medical therapy remains suboptimal. The START-SIAPAV-PAD registry was designed to describe characteristics, management and clinical history of patients with PAD in Italy. Baseline characteristics and treatment are reported. Patients and methods: START-SIAPAV-PAD is a prospective, multicentre, observational registry enrolling consecutive adults with PAD managed at 20 Italian Vascular centres, starting in February 2023. Standardised electronic case-report forms collect demographics, risk factors, comorbidities, haemodynamic parameters, vascular anatomy, therapies. Follow-up is planned for a minimum of 3 years. PAD severity is classified according to the Leriche-Fontaine scale, and risk-factor targets follow the 2024 ESC guidelines. Results: The present analysis includes 517 patients (72.0% male; median age 71 years) with a high prevalence of hypertension (79.2%), dyslipidaemia (85.0%), diabetes (36.9%), smoking (96.1% current or former) and chronic kidney disease (21.2%). Nearly half reported a walking distance <200 m, 77.5% had a resting ankle–brachial index ≤.80, and 17.2% presented with Leriche-Fontaine stage IV. Femoropopliteal disease was most frequent (69.8%), with multilevel involvement in 43.4%. Previous revascularisation was common, major amputation was rare. LDL cholesterol target (<55mg dL) was achieved in 27.9% of patients despite lipid-lowering therapy in 82.1%. Dual pathway inhibition, advanced lipid-lowering therapies, supervised exercise and structured smoking-cessation programmes were insufficiently adopted. Conclusions: In a population with advanced PAD and multiple risk factors we observed a substantial gap between guideline recommendations and real-world practice. Longitudinal follow-up will assess outcomes and opportunities to improve PAD management.