Overall survival |
In-hospital and 30-day morbidity and mortality |
Major adverse limb event – amputation (transtibial and above) or any major vascular re-intervention (thrombectomy, thrombolysis, balloon angioplasty, stenting or surgery) |
Major adverse cardiovascular event – (severe limb ischaemia and amputation affecting the contralateral limb, acute coronary syndrome, or stroke) |
Relief of ischaemic pain (visual analogue scale and medication usage) |
Psychological morbidity (Hospital Anxiety and Deprivation Score) |
Quality of life using generic (European Quality of life 5 level questionnaire, Short Form-12, ICEpop CAPability for older people and disease specific Vascular Quality of Life) tools |
Re- and cross-over intervention rates |
Healing of tissue loss (ulcers, gangrene) of presumed arterial aetiology as assessed by the Perfusion Extent Depth Infection Sensation [6] and Wound Ischaemia Foot Infection [7] scoring and classification systems |
Extent and healing of minor (toe and forefoot) amputations (also using the above wound scoring systems) |
Haemodynamic changes: absolute ankle and toe pressure, (ankle brachial pressure index and toe brachial pressure index). |