Endovascular-First Treatment Is Associated With Improved Amputation-Free Survival in Patients With Critical Limb Ischemia

Abstract

Background: Critical limb ischemia remains a difficult disease to treat, with limited level one data. The BEST-CLI trial (Best Endovascular vs Best Open Surgical Therapy in Patients with Critical Limb Ischemia) is attempting to answer whether initial treatment with open surgical bypass or endovascular therapy improves outcomes, although it remains in enrollment. This study aims to compare amputation-free survival and reintervention rates in patients treated with initial open surgical bypass or endovascular intervention for ischemic ulcers of the lower extremities. Methods and Results: Using California nonfederal hospital data linked to statewide death data, all patients with lower extremity ulcers and a diagnosis of peripheral artery disease who underwent a revascularization procedure from 2005 to 2013 were identified. Propensity scores were formulated from baseline patient characteristics. Inverse probability weighting was used with Kaplan–Meier analysis to determine amputation-free survival and time to reintervention for open versus endovascular treatment. Mixed-effects Cox proportional hazards modeling was used to adjust for patient ability to manage their disease and hospital revascularization volume. A total of 16 800 patients were identified. Open surgical bypass was the initial treatment in 5970 (36%) while 10 830 (64%) underwent endovascular interventions. Patients in the endovascular group were slightly younger compared with the open group (70 versus 71 years, ±12 years; P <0.001). Endovascular-first patients were more likely to have comorbid renal failure (36% versus 24%), coronary artery disease (34% versus 32%), congestive heart failure (19% versus 15%), and diabetes mellitus (65% versus 58%; all P values <0.05). After inverse propensity weighting as well as adjustment for patient ability to manage their disease and hospital revascularization experience, open surgery first was associated with a worse amputation-free survival (hazard ratio, 1.16; 95% CI, 1.13–1.20) with no difference in mortality (hazard ratio, 0.94; 95% CI, 0.89–1.11). Endovascular first was associated with higher rates of reintervention (hazard ratio, 1.19; 95% CI, 1.14–1.23). Conclusions: Patients with critical limb ischemia have multiple comorbidities, and initial surgical bypass is associated with poorer amputation-free survival compared with an endovascular-first approach, perhaps due to increased severity of wounds at the time of presentation.

Limb-Based Patency After Surgical vs Endovascular Revascularization in Patients with Chronic Limb-Threatening Ischemia

“…As reported in the SPINACH study, 10 better wound healing after surgical revascularization compared to EVT may be reflected in this better LBP for bypass surgery. However, a recent study comparing EVT and bypass surgery reported no significant differences in the limb salvage, amputationfree survival, or survival rates 15 ; it also reported that an EVT-first strategy improved limb salvage rates. In the present study, SPP was measured on the dorsal and plantar sides of the foot, which enabled evaluation of the ischemic conditions of the overall foot region, and the blood flow was found to be lower after EVT alone than after bypass surgery.…”

Spatial inequalities of major lower limb amputation rates in Paraná state, Brazil

“… 30 Moreover, a recent study showed that patients initially treated with open surgery presented higher lower limb amputation rates than those treated with endovascular techniques. 33 The authors concluded that the choice for open surgery was possibly being made for those patients with PAD at more advanced stages when prognosis is poorer. Although the correlation between MLLA rates and endovascular procedures was also significantly positive, it was 40% lower than the correlation with open surgeries, in agreement with a previous study that suggested that patients undergoing endovascular treatment will evolve with fewer MLLA rates.…”

“…Although the correlation between MLLA rates and endovascular procedures was also significantly positive, it was 40% lower than the correlation with open surgeries, in agreement with a previous study that suggested that patients undergoing endovascular treatment will evolve with fewer MLLA rates. 33 …”

2D perfusion DSA with an open-source, semi-automated, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty: a feasibility study

“…The weighted mean age-standardized prevalence and incidence of outpatient PAD in the USA have been recently estimated to be 11.8% and 22.4/1,000 person-years, respectively [2]. Minimal invasive endovascular treatment has become a mainstay in the treatment of PAD, due to high clinical success and low complication rates [3,4]. Especially for the management of critical limb ischemia (CLI), the most advanced stage of PAD which usually affects a more aged population with severe comorbidities and high surgical risk, endovascular treatment constitutes the best treatment option to avoid major limb amputation in significant percentages of everyday clinical practice [5,6].…”