Clinical Outcomes of Percutaneous Coronary Intervention Using Drug-Coated Balloons for De Novo Coronary Lesions With Eruptive Calcified Nodules as Detected by Optical Coherence Tomography.

Background: The clinical outcomes of percutaneous coronary intervention (PCI) using drug-coated balloons (DCB) for de novo coronary artery lesions with eruptive calcified nodules remain unclear.

Methods And Results: This retrospective study analyzed the long-term outcomes of 308 consecutive patients (389 lesions) treated with PCI using DCB under optical coherence tomography guidance for de novo coronary artery lesions between September 2018 and November 2020. Patients were classified into 2 groups: those with an eruptive calcified nodule in the culprit lesion (CN group) and those without (non-CN group). The primary endpoint was major adverse cardiovascular events (MACE), including clinically driven target lesion revascularization (TLR), myocardial infarction (MI), and cardiac death. The median follow-up period was 2.6 years (interquartile range 1.9-3.4 years). The CN group had significantly higher rates of MACE (hazard ratio [HR] 9.2; 95% confidence interval [CI] 4.1-20.2; P<0.0001), TLR (HR 5.0; 95% CI 1.7-15.1; P<0.01), MI (HR 30.5; 95% CI 5.0-184.8; P<0.001), and cardiac death (HR 25.1; 95% CI 8.7-72.6; P<0.0001) than the non-CN group. Results were similar even after adjusting for potential confounding factors using propensity score matching.

Conclusions: This study demonstrated that patients with eruptive calcified nodules who underwent PCI with DCB for de novo coronary artery lesions had worse long-term clinical outcomes than patients without such nodules.