Gene therapy for critical limb ischaemia: the TAMARIS trial

Abstract

Atherosclerosis in leg arteries disrupts blood flow in one in ten adults older than 50 years in high-income countries. 1 Aboyans V Criqui MH The epidemiology of peripheral arterial disease. in: Dieter RS Dieter III, RA Peripheral arterial disease. McGraw Hill, New York2009: 1-25 Google Scholar Fortunately, the severe clinical symptoms of critical limb ischaemia, such as rest pain, ulceration, and gangrene, are uncommon, with an annual incidence of 500–1000 per million population. 2 Norgren L Hiatt WR Dormandy JA Nehler MR Harris KA Fowkes FGR on behalf of the TASC II Working GroupInter-society consensus for the management of peripheral arterial disease. J Vasc Surg. 2007; 45: S5-S67 Summary Full Text Full Text PDF PubMed Scopus (4146) Google Scholar However, the prognosis for patients with critical limb ischaemia is bleak: 1 year after initial treatment, a quarter are dead, a third have had an amputation, and a fifth have continuing symptoms. 2 Norgren L Hiatt WR Dormandy JA Nehler MR Harris KA Fowkes FGR on behalf of the TASC II Working GroupInter-society consensus for the management of peripheral arterial disease. J Vasc Surg. 2007; 45: S5-S67 Summary Full Text Full Text PDF PubMed Scopus (4146) Google Scholar Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemiaTAMARIS provided no evidence that NV1FGF is effective in reduction of amputation or death in patients with critical limb ischaemia. Thus, this group of patients remains a major therapeutic challenge for the clinician. Full-Text PDF