Long term clinical outcomes of drug-coated balloon angioplasty in comparison to drug eluting stents following rotational atherectomy for calcified coronary lesions: a single center retrospective study

Background Drug-coated balloon (DCB) has emerged as potential alternative to drug-eluting stents (DES) in specific lesion subsets for de novo coronary lesions. However, evidence supporting DCB in severely calcified lesions remains limited. Quantitative flow ratio (QFR) is a noninvasive quantitative tool for evaluating post-procedural results following PCI. Purpose This study aimed to compare the clinical outcomes between DCB angioplasty and DES implantation in heavily calcified coronary lesions after rotational atherectomy (RA). Methods We retrospectively collected data from three hundred and fourteen consecutive patients with heavily calcified lesions who underwent DCB angioplasty (n=37) or DES implantation (n=277) after RA between Jan 2022 and June 2024 in our center. Patients with prior DES implantation in the target vessel or treated with both DCB and DES in the target vessel were excluded from the study. Results The baseline clinical characteristics showed that compared with DES group, patients in DCB group had a lower LVEF (56.3±10.8% vs 61.3±7.8%, p=0.01). Regarding RA, no significant differences were observed between the two groups in terms of initial or final burr size, or the total number of burrs used. However, the RA speed was significantly higher in the DCB group (19.5±1.5 vs 18.7±1.7×105 RPM, p=0.003). Furthermore, device diameter and length were significantly smaller and shorter in the DCB group compared to the DES group (2.6 ±0.3 mm vs 3.0 ± 0.4 mm, p < 0.001; and 38.1 ±18.8 mm vs 53.2 ± 22.6 mm, p< 0.001, respectively). Post-procedural target vessel QFR (PPQFRV) was higher in DES group as compared with DCB group(0.88±0.11 vs 0.78±0.12, p<0.001). During the median follow-up of 571 days, no significant differences were observed between the DES and DCB groups regarding the rates of clinically driven target vessel revascularization (10.1% vs. 8.1%), target vessel myocardial infarction (3.6% vs. 5.4%), or cardiac death (1.8% vs. 2.7%). The long-term rates of major adverse cardiovascular events (MACE) were also comparable between the two groups (14.4% in DES group vs 16.2% in DCB group, p=0.816)(Figure 1). Multivariate analysis revealed that PPQFRV lacked independent prognostic value for MACE in the entire cohort and the DES subgroup. In contrast, PPQFRV remained independently associated with MACE risk among patients treated with DCB (p=0.029). The cut-off value for PPQFRV in the DCB group to predict MACEs during follow-up was 0.715 (AUC=0.758; sensitivity, 0.667; specificity, 0.806; P=0.048)(Figure2). Conclusion For highly calcified coronary lesions, relative to DES, treatment with DCB after RA could provide clinically favorable results despite lower PPQFRV. Lower PPQFRV (0.72-0.80) may be acceptable after DCB treatment in such lesions.