Drug‐coated balloon strategy following orbital atherectomy for calcified coronary artery compared with drug‐eluting stent: One‐year outcomes and optical coherence tomography assessment

Abstract Background Percutaneous coronary intervention (PCI) for calcified coronary artery remains challenging in the drug‐eluting stent (DES) era. While recent studies reported the efficacy of orbital atherectomy (OA) combined with DES for calcified lesion, the effectiveness of drug‐coated balloon (DCB) following OA has not been fully elucidated. Methods Between June 2018 and June 2021, 135 patients who received PCI for calcified de novo coronary lesions with OA were enrolled and divided into two groups; OA followed by DCB ( n = 43) if the target lesion achieved acceptable preparation, or second‐ or third‐generation DESs ( n = 92) if the target lesion showed suboptimal preparation between June 2018 and June 2021. All patients underwent PCI with optical coherence tomography (OCT) imaging. The primary endpoint was 1‐year major adverse cardiac event (MACE), that was a composite of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. Results Mean age was 73 years and 82% was male. In OCT analysis, maximum calcium plaque was thicker (median: 1050 µm [interquartile range (IQR): 945–1175 µm] vs. 960 µm [808–1100 µm], p = 0.017), calcification arc tended to larger (median: 265° [IQR: 209–360°] vs. 222° [162–305°], p = 0.058) in patients with DCB than in DES, and the postprocedure minimum lumen area was smaller in DCB compared with minimum stent area in DES (median: 3.83 mm 2 [IQR: 3.30–4.52 mm 2 ] vs. 4.86 mm 2 [4.05–5.82 mm 2 ], p < 0.001). However, 1 year MACE free rate was not significantly different between 2 groups (90.3% in DCB vs. 96.6% in DES, log‐rank p = 0.136). In the subgroup analysis of 14 patients who underwent follow‐up OCT imaging, late lumen area loss was lower in patients with DCB than DES, despite lower lesion expansion rate in DCB than DES. Conclusions In calcified coronary artery disease, DCB alone strategy (if acceptable lesion preparation was performed with OA) was feasible compared with DES following OA with respect to 1‐year clinical outcomes. Our finding indicated using DCB with OA might be reduce late lumen area loss for severe calcified lesion.