Comparison of Clinical Outcomes in Patients with Acute Lower Limb Ischaemia Undergoing Endovascular Therapy and Open Surgical Revascularisation: A Large Scale Analysis in Japan

Abstract

The recommended revascularisation methods for acute limb ischaemia (ALI), which is caused by embolism and atherosclerotic thrombosis, include endovascular therapy (EVT) and open surgical revascularisation (OSR); however, treatment choices based on patient characteristics remain controversial. This retrospective analysis from the Japanese Registry of All Cardiac and Vascular Diseases - Diagnosis Procedure Combination database (April 2012 to March 2020) evaluated differences in clinical outcomes and identified prognostic predictors in patients with ALI. This study analysed 10 977 patients with lower limb ALI. EVT was defined as catheter directed thrombolysis, percutaneous thrombectomy, or percutaneous angioplasty with balloon dilatation and or stenting. OSR was defined as Fogarty thrombectomy, bypass surgery, or thromboendarterectomy. The EVT and OSR groups were compared after propensity score matching (PSM) considering ten clinical covariates. The EVT group had more patients at higher risk of atherosclerotic disease than the OSR group. The OSR group had more patients at a higher risk of embolism, including atrial fibrillation and atrial flutter, than the EVT group. In the EVT group, 20.4% of patients underwent catheter directed thrombolysis using urokinase, the only thrombolytic agent available in Japan that is covered under insurance. After PSM, in hospital mortality (odds ratio [OR] 1.33, 95% confidence interval [CI] 1.11 - 1.59; p = .002), major amputation rate (OR 1.43, 95% CI 1.19 - 1.72; p < .001), major amputation and or death rate (OR 1.42, 95% CI 1.24 - 1.62; p < .001), and total hospitalisation cost (1.16 vs. 0.97 million yen; p < .001) were statistically significantly higher in the EVT group than in the OSR group. In interaction analyses, peripheral artery disease (PAD) was a factor responsible for reducing OSR efficacy in terms of major amputation and or death rate (with PAD, OR 0.94, 95% CI 0.68 - 1.29; without PAD, OR 1.56, 95% CI 1.34 - 1.82; p = .004). In Japan, EVT was a less effective primary treatment for patients with ALI than OSR, except for those with PAD.