Benefit of immediate revascularization in women with critical limb ischemia in an intention-to-treat analysis.
ABSTRACT Evidence for the best treatment strategy in women with critical limb ischemia (CLI) is limited and controversial with studies contradicting each other. Therefore, we determined the benefit of immediate revascularization compared to medical therapy (MT) with optional delayed revascularization in men and women with CLI.
This cohort study with follow-up at 2, 6, and 12 months was conducted in a consecutive series of 356 patients (41% women) presenting with 394 critically ischemic limbs. In this intention-to-treat study, 292 limbs were assigned to immediate revascularization by either surgical (81 limbs) or endovascular techniques (211 limbs) at the time of first presentation with CLI, whereas MT as first-line therapy was administered in 102 limbs with CLI. Primary outcome measures were overall and amputation-free survival. Cox-regression models adjusted for 10 baseline characteristics following Kaplan-Meier Survival estimates were performed.
Women with CLI were significantly older than men (P < .001), had higher systolic blood pressure (P = .03) and cholesterol levels (P = .04), but less women presented with renal failure (P = .03) and less were smokers (P < .001). In women, but not in men, immediate revascularization was associated with a prolonged overall survival (hazard ratio [HR], 2.37; 95% confidence interval [CI], 1.29-4.34; P = .01) and amputation-free survival compared to MT (HR, 2.11; 95% CI, 1.30-3.43; P = .01), irrespective of whether surgery or percutaneous transluminal angioplasty (PTA) was performed (not significant). Except for overall survival (HR, 2.14; 95% CI, 0.95-4.82; P = .07), outcomes were not significantly changed after Cox regression analysis.
Women presenting with CLI profit from immediate revascularization therapy, irrespective of revascularization technique used and despite advanced age and differences in other cardiovascular risk factors. Thus, our data suggest aggressive and early limb salvage efforts in women with CLI.