German CRITISCH Registry Evaluates Endovascular CLI Treatment Outcomes in Octogenarians
July 12, 2017—Online in Journal of Endovascular Therapy, Christian Uhl, MD, et al published findings from the CRITISCH study evaluating the outcomes and periprocedural risk of endovascular revascularization in octogenarians with critical limb ischemia (CLI) compared to younger CLI patients. The CRITISCH study was sponsored by St. Franziskus Hospital in Münster, Germany, where it was led by Theodosius Bisdas, MD.
As summarized in Journal of Endovascular Therapy, CRITISCH is a multicenter, prospective registry for first-line treatments in patients with CLI that enrolled 642 patients treated with endovascular techniques. The patients were dichotomized by age into group 1 (< 80 years; n = 421; mean age, 69 years; 292 men) or group 2 (≥ 80 years; n = 221; mean age, 85 years; 113 men). The groups had similar distributions in terms of Rutherford categories 4 to 6, but group 1 had more men, smokers, diabetics, and patients on dialysis.
The study's primary composite endpoint was amputation and/or death. Key secondary endpoints were 1-year in-hospital mortality and major amputation, as well as major adverse limb events (MALEs), which were any reinterventions or major amputations involving the index limb.
The investigators found that in-hospital mortality was 1% in group 1 and 2% in group 2 (P = .204), and the major amputation rates were 4% and 2% (P = .169), respectively. Amputation-free survival at 1 year was 75% in group 1 and 77% in group 2 (P = .34), whereas freedom from MALEs was significantly different between the groups: 62% in group 1 versus 72% in group 2 (hazard ratio, 1.45; 95% confidence interval, 1.09–1.93; P = .016). Limb salvage was 90% in group 1 and 95% in group 2 (hazard ratio, 2.16; 95% confidence interval, 1.27–3.69; P = .01).
Octogenarians with CLI who were treated by endovascular means showed comparable early and 1-year amputation-free survival rates versus their younger counterparts, and limb salvage and freedom from MALE rates were even higher in octogenarians, concluded the CRITISCH investigators in Journal of Endovascular Therapy.