Abstract
Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.
Highlights
Since the report of the Transatlantic Inter-Society Consensus (TASC) II guideline in 2007, endovascular therapy has become one of the first-line treatment strategies for patients with critical limb ischemia (CLI) [1]
With the development of device technology, various devices and methods have been newly adopted in the treatment of CLI patients with BTK lesions, such as conventional balloons, drug-coated balloons (DCBs), bare metal stents (BMSs), and drug-eluting stents (DESs) [7,8,9,10]
The baseline clinical and laboratory characteristics were similar between the two groups; the hemoglobin level was lower in the plain old balloon angioplasty (POBA) group than in the stent group
Summary
Since the report of the Transatlantic Inter-Society Consensus (TASC) II guideline in 2007, endovascular therapy has become one of the first-line treatment strategies for patients with critical limb ischemia (CLI) [1]. A similar limb salvage rate of PTA was achieved in the treatment of CLI with below-the-knee (BTK) lesions when compared with surgery. The higher rate of target lesion revascularization (TLR) and the lower primary patency rate are still causing concerns [4]. With the accumulation of experience and evidence, interventional treatment has largely replaced the surgical treatment worldwide in the treatment of CLI with BTK lesions [5, 6]. With the development of device technology, various devices and methods have been newly adopted in the treatment of CLI patients with BTK lesions, such as conventional balloons, drug-coated balloons (DCBs), bare metal stents (BMSs), and drug-eluting stents (DESs) [7,8,9,10]. Despite improvements in device technology and interventional techniques, limited rates of primary patency and TLR remain unsolved problems
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