MALE – Major adverse limb events

MALE – Major adverse limb events

MALE – Major adverse limb events is considered in the setting of peripheral arterial disease and peripheral interventions. It includes major amputation, reintervention which could be surgical or repeat angioplasty. Major amputation is defined as amputation above the ankle. Amputation at the tarsometatarsal level (Lisfranc level) or below is not considered as a failure of limb salvage [1].

Major vascular re-interventions are thrombectomy, thrombolysis or major surgical procedure – new bypass graft, jump/interposition graft revision in the index limb [2].

In the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial [3], of the 128 patients who had a MALE, 20.5% had a vascular amputation in 1 year. The risk of hospitalization was 61.5% and that of death 8.3%. These figures underline the significance of MALE in those with limb ischemia.


  1. Iida O, Soga Y, Yamauchi Y, Hirano K, Kawasaki D, Tazaki J, Yamaoka T, Suematsu N, Suzuki K, Shintani Y, Miyashita Y, Takahara M, Uematsu M. Anatomical predictors of major adverse limb events after infrapopliteal angioplasty for patients with critical limb ischaemia due to pure isolated infrapopliteal lesions. Eur J Vasc Endovasc Surg. 2012 Sep;44(3):318-24.
  2. Conte MS. Understanding objective performance goals for critical limb ischemia trials. Semin Vasc Surg. 2010 Sep;23(3):129-37.
  3. Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315.

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