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 mm2 [IQR 3.30-4.52 mm2 ] vs. 4.86 mm2 [4.05-5.82 mm2 ], 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.