Subintimal Crossing of Chronic Total Occlusions in Peripheral Arteries With a Dual Guidewire Balloon Catheter: The PRAESTO Study.

ABSTRACT

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of antegrade fenestration re-entry (AFR) using a dual guidewire angioplasty balloon for chronic total occlusion (CTO) in patients with peripheral artery disease (PAD). MATERIAL AND METHODS: This is a retrospective score matching analysis study comparing a study cohort composed of PAD patients with CTO treated with AFR subintimal recanalization using a dual guidewire angioplasty balloon and a matched control group, selected on baseline cardiovascular risk factor and lesions characteristics, treated with a conventional subintimal recanalization. Procedure outcomes include procedural success, successful subintimal re-entry, need for distal puncture, procedural time, fluoroscopy time, and dose area product. Clinical variables, including primary patency, freedom from amputation, freedom from re-interventions, and freedom from death, were used to compare the study groups. RESULTS: Thirty patients in the study group were compared with 60 patients in the matched control group (mean age, male). A significant higher subintimal re-entry success (100% vs 76.7% in control group, p=0.004) and lower need of distal tibial punction (0 vs 14 [23.3%] patients in control group, p=0.004) were observed in the study group. A surgical conversion to bypass was needed in 5 patients in the control group. Shorter procedural and fluoroscopy time were observed in the study group (41.1±10.8 minutes vs 146.6±62. and 16.7±3.5 minutes vs 34.3±14.2 minutes in control group respectively, p<0.001 and p<0.001). Lower DAP were observed in the study group (914.1±309.9 µGym² vs 2026.5±845.7 µGym² in control group p<0.001). No significant difference were observed in terms of primary patency, mortality, amputation, and freedom from re-intervention. CONCLUSION: AFR using the Presto dual guidewire balloon is a step forward for crossing CTO which allows a simplified and quick treatment of BTK and ATK lesions compared with conventional approaches without increase of procedural risk and maintaining good clinical outcomes.