Drug coated balloon vs. drug eluting stent in calcified de novo coronary lesions: Long term outcomes from the SPARTAN registry

Aim Coronary artery calcification presents major challenges during PCI, including device deliverability, suboptimal lesion preparation, impaired stent expansion, increased restenosis, stent thrombosis and mortality. Drug-coated balloons (DCB) offer a stent-less alternative, but evidence in de novo calcified lesions is limited. This study compared long-term clinical outcomes between DCB and drug-eluting stent (DES) strategies in such lesions.Methods We retrospectively identified all patients undergoing PCI for operator reported angiographically calcified de novo lesions between January 2015 and November 2019. Patients presenting with cardiac arrest, intubation, or cardiogenic shock were excluded. The primary endpoint was target lesion failure (TLF), defined as a composite of target lesion revascularisation (TLR), target lesion myocardial infarction (TLMI) and cardiovascular death. Secondary endpoints included the individual components of TLF and all-cause mortality.Results A total of 1,057 patients were included (DCB n=506; DES n=551). Over a median follow-up of 3.7 years, TLF was similar between groups (11.5% DCB vs 10.9% DES; adjusted HR 1.07, 95% CI 0.71-1.62; p=0.733). TLR rates were also similar (6.7% vs 6.4%; HR 1.02, 95% CI 0.60-1.73; p=0.954). TLMI was significantly lower with DCB (1.6% vs 3.4%; HR 0.38, 95% CI 0.16-0.89; p=0.025). Cardiovascular and all-cause mortality did not differ significantly between groups. Independent predictors of TLF were age, diabetes, and renal dysfunction, reflecting underlying systemic atherosclerotic burden.Conclusion In this retrospective study involving operator reported calcified lesions, DCB use was associated with similar overall outcomes with observed lower rates of TLMI compared with DES. These findings are exploratory and require confirmation in RCTs.