Stent revascularization versus bypass surgery for peripheral artery disease in type 2 diabetic patients - an instrumental variable analysis.

Chia-Hsuin Chang,Mei-Shu Lai,Li-Chiu Wu,Jiun Hsu,Jou-Wei Lin

doi:10.1038/srep37177

Abstract

The objective of this study was to use instrumental variable (IV) analyses to evaluate the clinical effectiveness of percutaneous stent revascularization versus bypass surgery in the treatment of peripheral artery disease (PAD) among type 2 diabetic patients. Type 2 diabetic patients who received peripheral artery bypass surgery (n = 5,652) or stent revascularization (n = 659) for lower extremity arterial stenosis between 2000 and 2007 were identified from the Taiwan National Health Insurance claims database. Patients were followed from the date of index hospitalization for 2 years for lower-extremity amputation, revascularization, and hospitalization for medical treatment. Analysis using treatment year, patients’ monthly income level, and regional difference as IVs were conducted to reduce unobserved treatment selection bias. The crude analysis showed a statistically significant risk reduction in favor of stent placement in lower extremity amputation and in the composite endpoint of amputation, revascularization, or hospitalization for medical treatment. However, peripheral artery stent revascularization and bypass surgery had similar risk of lower limb amputation and composite endpoints in the analyses using calendar year or patients’ monthly income level as IVs. These two treatment modalities had similar risk of lower limb amputation among DM patients with PAD.

Highlights

Peripheral artery disease (PAD), which results from progressive narrowing of arteries secondary to atherosclerosis, has increased in prevalence and put a severe burden on the patients as well as the economy[1,2]
A total of 6,342 new patients receiving endovascular stents or bypass surgery for lower extremity arterial stenosis were identified during the study period
The results of this study demonstrated that, among type 2 diabetic patients, percutaneous stent revascularization for lower extremity arterial stenosis is not superior to open bypass surgery in reducing lower limb amputation rates during the first two years following the procedure

Summary

Introduction

Peripheral artery disease (PAD), which results from progressive narrowing of arteries secondary to atherosclerosis, has increased in prevalence and put a severe burden on the patients as well as the economy[1,2]. Studies suggested that for the treatment of focal iliac stenosis and occlusion, PTA with or without stenting has become a viable alternative to surgical reconstruction due to its safety and acceptable long-term outcomes[11,12,13]. Little is known regarding the comparative effectiveness of stent revascularization versus bypass surgery, and currently available literature suggests that there is probably no difference in the clinical outcome[17]. No randomized trial comparing the efficacy between endovascular stenting and bypass surgery in diabetic patients with lower extremity PAD has been published. Despite an increasing number of DM patients received stent revascularization for lower extremity arterial occlusive disease, a large-scale study comparing the clinical effectiveness in limb salvage between those who underwent percutaneous stent revascularization or bypass surgery for more distal lower extremity arterial disease in real clinical setting is still lacking[18].

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