Presentation and Management of Acute Limb Ischemia Following Lower Extremity Revascularization: Insights from the VOYAGER PAD Trial

Abstract

Acute limb ischemia (ALI) is a major adverse limb event associated with high morbidity and mortality. Despite the severity of this outcome, there are few large datasets including adjudicated ALI outcomes that have elucidated treatment approaches and outcomes after ALI. Data describing the presentation, initial care, and subsequent antithrombotic prophylaxis in patients with ALI after lower extremity revascularization (LER) for symptomatic peripheral artery disease (PAD) would provide valuable insights. The VOYAGER PAD trial randomized patients with PAD after LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. Patients were randomized across 34 countries. Site-reported ALI was independently adjudicated by a clinical events committee. Each event was categorized by trained vascular specialists for etiology, relationship to index or subsequent LER, inpatient therapy, discharge treatment strategy, and hospital outcomes. Of the 6564 randomized patients, 390 (5.9%) had 516 total ALI events during follow-up. ALI etiology was in situ thrombosis in 97.8%, embolism from nonextremity source in 1.9%, and undetermined in 0.3%. Anatomic location was prior bypass in 49%, arterial stent in 31%, and native arterial segment (of these, three-quarters were prior endarterectomy, atherectomy, or angioplasty sites) in 18%. Fifty-eight percent of ALI were related to the index LER, 36% were related to a prior or subsequent nonindex LER, and 6% were at a non-LER arterial site. The initial intervention strategy (Fig 1) was thrombectomy in 41% (three-quarters were open and 71% required an additional open/endovascular revascularization or major amputation at some point in hospitalization). Thrombolysis was the initial strategy in 19% and 76% of these underwent an additional open/endovascular revascularization or major amputation during the hospitalization. Median hospital stay was 6 days. Fasciotomy occurred in 6% of patients, severe complications (ventilator, shock, or dialysis) occurred in 4%, major amputation in 13%, and mortality in 2.3%. Discharge antithrombotic background therapy (excluding study drug) was variable (Fig 2). ALI in the post-LER setting is frequent and largely in-situ thrombosis at the site of prior LER. Presentation with ALI is associated with prolonged hospitalization, the need for procedures and/or amputation and high inpatient mortality. Initial therapeutic approaches in patients presenting with ALI are varied as are approaches to thromboprophylaxis. These observations highlight the need for future research investigating the optimal approach to treating patients with ALI and therapeutic strategies to prevent recurrent complications.Fig 2Discharge Anti-Thrombotic Regimen.View Large Image Figure ViewerDownload Hi-res image Download (PPT)