Key result
DCB yields similar target lesion failure to DES in de novo aorto-ostial lesions.
Why the study?
Aorto-ostial de novo coronary lesions have historically high restenosis rates even with contemporary DES platforms, and data on using DCB as a stent-less alternative in these lesions were limited.
Does a paclitaxel drug-coated balloon (DCB)-only strategy reduce target lesion failure compared to drug-eluting stents (DES) in patients undergoing PCI for de novo aorto-ostial coronary lesions?
Cohort (n=197)
Single-blind
No
Does a paclitaxel drug-coated balloon (DCB)-only strategy reduce target lesion failure compared to drug-eluting stents (DES) in patients undergoing PCI for de novo aorto-ostial coronary lesions?
In a real-world cohort of patients with de novo aorto-ostial coronary lesions, a paclitaxel drug-coated balloon-only PCI strategy was feasible and associated with similar long-term clinical outcomes (median 3.7 years) and favourable late lumen gain compared with drug-eluting stents.
Drug-coated balloon angioplasty showed comparable target lesion failure to drug-eluting stents; leaves open a potential role in de novo aorto-ostial lesions pending randomized data.
Background Aorto-ostial de novo coronary lesions (AOL) represent a technically challenging subset of coronary artery disease with historically high restenosis rates, even with contemporary drug-eluting stent (DES) platforms. Drug-coated balloons (DCB) offer a stent-less alternative strategy; however, data on their use in AOL are limited. We aimed to compare long-term clinical outcomes of DCB vs. DES in de novo AOL. Methods We identified all patients undergoing percutaneous coronary intervention (PCI) with either DCB or DES for de novo AOL as their first procedure between January 2015 and November 2019. 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, target vessel revascularisation and all-cause mortality. Exploratory quantitative coronary angiography (QCA) analysis was performed on any follow up angiograms obtained that were technically feasible. Clinical outcomes were obtained using national outcome datasets. Results A total of 197 patients with aorto-ostial lesions were included (DES n = 140; DCB n = 57). Over a median follow-up of 3.7 years, TLF occurred in 17.1% of DES-treated lesions and 14.0% of DCB-treated lesions (HR: 0.79, 95% CI: 0.35–1.76; p = 0.563). Rates of TLR, TVR, TLMI, cardiovascular mortality, and all-cause mortality were similar between groups. Severe calcification and creatinine independently predicted TLF. Follow-up QCA was available in 59 lesions over varying time intervals and demonstrated lower late lumen loss (LLL) following DCB treatment, compared with DES-treated lesions. Conclusion In this real-world cohort with aorto-ostial coronary lesions, a DCB-only strategy was feasible and associated with similar long-term outcomes to DES. Exploratory angiographic analyses demonstrated significant late lumen gain following DCB treatment. These findings are hypothesis-generating and support further prospective evaluation of a DCB approach in aorto-ostial coronary disease.
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Natarajan et al. (2026) conducted a cohort in De novo aorto-ostial coronary lesions (n=197). Paclitaxel-coated balloon (DCB) vs. Drug-eluting stent (DES) was evaluated on Target lesion failure (TLF), a composite of target lesion revascularisation (TLR), target lesion myocardial infarction (TLMI), and cardiovascular death (HR 0.79, 95% CI 0.35-1.76, p=0.563). Drug-coated balloon angioplasty had similar target lesion failure rates compared to drug-eluting stents (14.0% vs 17.1%; HR 0.79, 95% CI 0.35-1.76; p=0.563) in de novo aorto-ostial coronary lesions.
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