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

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.