Safety and efficacy of systematic lesion preparation with a novel generation scoring balloon in complex percutaneous interventions: results from a prospective registry.

Abstract

Coronary lesions predilatation with semicompliant (SC) or non-compliant balloons (NC) may be insufficient to obtain an optimal stent expansion, which can lead to in-stent restenosis or thrombosis. Moreover, increasing evidence supporting an optimal lesion preparation is mandatory when drug coated balloons (DCB) are used. To this extent, more "aggressive tools" such as cutting/scoring balloons, atherectomy or lithotripsy may play an important role and improve outcomes. We enrolled 78 consecutive patients from March 2020 to October 2020 with calcific/fibrotic or ostially-located lesions, which were prepared using scoring balloons, in addition to SC/NC balloons and other plaque modification strategies. The final treatment consisted in either stent or DCB usage. The primary endpoint was the rate of clinically-driven target lesion revascularization. Secondary endpoints entailed the procedural success and the individual rates of major adverse cardiac events (MACE) at 12 months. Most of the patients had left main (LM) or ostial lesions, 65% of them being moderate/severely calcified, with further debulking strategies being required in 15 (19.2%) patients (rotational atherectomy, 3.8% or coronary intravascular lithotripsy, 15.3%). A high-rate of DCB usage was reported. Angiographic and procedural success was obtained in 77 and 76 patients, respectively. We encountered one vessel perforation, which was sealed with a covered stent, without consequence. During follo- up, we observed only 6 MACE, 6 target lesion revascularizations (TLR) and 2 cardiovascular deaths. Among patients with high complexity and calcific lesions, an optimal lesion preparation using a dedicated scoring balloon was associated with low clinical events at mid-term follow-up and may be considered to improve immediate procedural success rate.