Abstract

Abstract Background Percutaneous coronary interventions (PCI) in calcified coronary artery lesions is associated with higher rate of cardiovascular adverse events and mortality. The aim of our study was to evaluate the prognostic impact of High Bleeding Risk (HBR) condition, as defined by the Academic Research Consortium (ARC) HBR criteria, on clinical outcomes in patients with complex calcified coronary artery disease undergoing PCI after lesion preparation using Rotational Atherectomy (RA). Methods In this observational retrospective study, all patients with calcified coronary artery disease undergoing RA-assisted PCI between 2011 and 2021 were included. According to ARC-HBR criteria, patients were considered at HBR if at least one major criterion or two minor criteria were met. The primary endpoint was the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 4 years defined as the composite of cardiovascular death, myocardial infarction, stroke and target vessel revascularization (TVR). Secondary endpoints were cardiovascular death, bleeding events and TVR. Results The final population consisted of 343 patients. Median follow-up was 39 months. Among patients, 198 (57,7%) met the HBR criteria while 145 (42,7%) did not. Patients with HBR criteria were older [78.21 vs 71.68; p < 0.001], with lower GFR (ml/min/1.73m2) [53.67 vs 77.51; p < 0.001] and lower hemoglobin levels [Hb: g/dl; 11.93 vs 13.74; p < 0.001] compare with patients without HBR. The rate of MACCE was significantly higher in patients at HBR compare with patients not at HBR (HR 1.86 [1.08-3.26]; p = 0.026) mainly driven by an increased risk of cardiovascular death. No significant differences were found concerning the rates of TVR (HR 0.48 [0.21-1.04]; p = 0.057), stroke (HR=7.7 [0.98-61.09], p=0.05) and MI (HR 2.2[0.58-8.35], p=0.241) between the two groups. Bleedings were more frequent in patients at HBR (HR 12.31 [2.93-51.64]; p < 0.001) compared to patients without HBR. Conclusion In patients with calcified coronary artery disease PCI, despite the use of dedicated tools for optimal lesion preparation such as RA, those at HBR still present higher risk of MACCE and cardiovascular death. Conversely, rates of TVR and MI were comparable, suggesting frailty and comorbidities as primary causes of worse outcomes in patients at HBR. Figure Legend: Panel A: the rate of MACCE was significantly higher in patients at HBR compare with patients not at HBR (HR 1.86 [1.08-3.26]; p = 0.026),) mainly driven by an increased risk of cardiovascular death (Panel B). Panel C: the rates of TVR were not significant different between the two groups (HR 0.48 [0.21-1.04]; p = 0.057). Panel D: Bleedings were more frequent in patients at HBR (HR 12.31 [2.93-51.64]; p < 0.001) compared to patients without HBR.

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