New scoring balloon to treat moderate-to-severe calcified coronary lesions. The first-in-man Naviscore study.

Abstract

INTRODUCTION AND OBJECTIVES: Calcified coronary lesions are becoming more prevalent and remain therapeutically challenging. Although a variety of devices can be used in this setting, cutting balloons (CB) and scoring balloons (SB) are powerful and simple tools to treat calcified plaques vs more complex devices. However, there are some drawbacks: these are stiff and bulky balloons that, as a first device, complicate lesion crossing and navigability in the presence of tortuosity, thus making it extremely difficult to recross once the balloon has been inflated. The objective of this study was to evaluate the safety and efficacy profile of the new Naviscore SB designed to overcome these drawbacks. METHODS: The first-in-man Naviscore Registry is a multicenter, prospective trial that included 85 patients with moderate (34%) or severe (66%) de novo calcified coronary lesions located in the native arteries, with stable angina and an indication for percutaneous coronary intervention. RESULTS: Mean age was 71 ± 11 years, with a high prevalence of comorbidities. Used as the first device, the Naviscore was able to cross 76% of the lesions and was used in 98% of the cases effectively modifying the calcified plaque. Procedural success was achieved in 94% of cases. Basal stenosis of 81 ± 12% decreased to 33 ± 8.5% after Naviscore and to 7.5 ± 2.6% after stent implantation. There were no major adverse cardiovascular events during admission. Perforation, device entrapment or flow-limiting dissections did not occur-only type A/B dissections in 13%-which were fixed with stent implantation. Device performance was deemed superior to the usual SB or CB used by the participant centers. CONCLUSIONS: The Naviscore SB is very effective crossing severely calcified lesions as the first device, with effective plaque modification, stent expansion and an excellent safety profile. The Naviscore improves the behavior of current CB and SB. Due to its simplicity of use and performance, the Naviscore can be the first-choice SB to treat significant calcified lesions.