Key result
Sirolimus-coated balloon matches everolimus-eluting stent for 12-month target-lesion failure.
Why the study?
Drug-eluting stents leave a permanent implant that can cause late device-related events in de novo coronary artery disease. Whether a sirolimus-coated balloon strategy is non-inferior to everolimus-eluting stent implantation after successful lesion preparation was uncertain.
Is a sirolimus-coated balloon strategy with bailout stenting non-inferior to everolimus-eluting stent implantation for preventing target-lesion failure at 12 months in patients with de novo native-vessel coronary artery disease?
RCT (n=1,842)
Open-label
1:1 ratio
Yes
Is a sirolimus-coated balloon strategy with bailout stenting non-inferior to everolimus-eluting stent implantation for preventing target-lesion failure at 12 months in patients with de novo native-vessel coronary artery disease?
In patients with de novo native coronary artery disease and successful lesion preparation, a sirolimus-coated balloon strategy with bailout stenting is non-inferior to standard everolimus-eluting stent implantation for target-lesion failure at 12 months.
Answers are grounded in this paper and cite their sources.
Sirolimus-coated balloon offers viable stent-free option for de novo lesions; extends randomized evidence beyond in-stent restenosis.
Background: Drug-eluting stents remain standard treatment for de novo coronary artery disease but leave a permanent implant that can cause late device-related events. Whether a sirolimus-coated balloon (SCB) strategy is non-inferior to implantation of an everolimus-eluting stent (EES) after successful lesion preparation is uncertain. Methods: In this investigator-initiated, international, open-label, non-inferiority trial done in 53 centres in 11 countries, patients with a de novo native-vessel lesion and successful lesion preparation were randomly assigned in a 1:1 ratio to an SCB strategy with bailout stenting or to EES implantation. The primary end point was target-lesion failure (death from cardiac causes, target-vessel myocardial infarction, or ischaemia-driven target-lesion revascularisation) at 12 months. The trial is registered with ClinicalTrials.gov, NCT04893291 and is complete. Findings: Between December, 2021 and June, 2025, a total of 1842 patients (mean age 62·9 years [SD 11·3]) were randomly assigned to the SCB group (n=922) or the EES group (920); 401 (21·7%) participants were female patients. At 12 months, a primary end-point event had occurred in 19 patients (2·06%) in the SCB group and in 22 patients (2·39%) in the EES group (hazard ratio [HR], 0·86; 95% confidence interval [CI], 0·47–1·59). The difference in Kaplan–Meier estimates was −0·40 percentage points (95% CI, −1·81 to 1·00; one-sided upper boundary, 0·78 percentage points; P=0·004 for non-inferiority). Rates of death, myocardial infarction, stroke, ischaemia-driven target-lesion revascularisation, major bleeding, and lesion thrombosis were similar between groups. Interpretation: Among patients with de novo coronary artery disease treated after successful lesion preparation, an SCB strategy with bailout stenting if needed was non-inferior to EES implantation with respect to target-lesion failure at 12 months.
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Cortese et al. (2026) conducted an RCT in De novo native-vessel coronary artery disease (n=1,842). Sirolimus-coated balloon (SCB) strategy with bailout stenting vs. Everolimus-eluting stent (EES) implantation was evaluated on Target-lesion failure (death from cardiac causes, target-vessel myocardial infarction, or ischaemia-driven target-lesion revascularisation) at 12 months (HR 0.86, 95% CI 0.47-1.59, p=0.004 for non-inferiority). Sirolimus-coated balloon strategy was non-inferior to everolimus-eluting stent for 12-month target-lesion failure (2.06% vs 2.39%; HR 0.86, 95% CI 0.47-1.59; P=0.004 for non-inferiority).
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