Outcomes

Prior to defining the endpoints, a clarification on major vs minor limb events. For our purposes below we'll define this distinction as:

  • major limb event: new or jump graft, thrombectomy, thrombolysis
  • minor limb event: repeat endovascular procedure (without thrombolysis, a new stent, other minor revision (patch)

Formal definitions: The CLI Performance Goals Committee currently has nine outcomes.

Amputation (AMP) :

  • Above ankle amputation of the index limb.

Death (DTH) :

  • Death (any cause).

Amputation-free survival (AFS) :

  • Above ankle amputation of the index limb
  • or death (any cause).

Amputation reintervention free (RAO) :

  • Above ankle amputation of the index limb
  • or reintervention (minor limb event).
  • Censored at death.

Major adverse limb event (MALE) :

  • Above ankle amputation of the index limb
  • or major reintervention (see above).
  • Censored at death.

Major adverse limb event peri-operative death (MALE+POD) :

  • Above ankle amputation of the index limb
  • death within 30 days
  • or major reintervention (see above).
  • PLEASE NOTE : MALE+POD and MALEPOS are used synonymously in some places (the latter for legacy reasons).

Amputation reintervention free stenosis (RAS) :

  • Above ankle amputation of the index limb
  • reintervention (minor limb event)
  • or restenosis
  • Censored at death.

Major adverse cardiac event (MACE) :

  • MI
  • Stroke
  • Death.

Major adverse cardiac event or amputation (MACEAMP) :

  • MI
  • Stroke
  • Death
  • or Amputation

----RETIRED ENDPOINTS----

Amputation/reintervention-free survival (RAD) :

  • Above ankle amputation of the index limb
  • death (any cause)
  • or reintervention.

Major adverse limb event free survival (MALEFS) :

  • Above ankle amputation of the index limb
  • death
  • or major reintervention (see above).