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Sirolimus- Versus Paclitaxel-Coated Balloons for Treatment of Coronary Artery Disease
Pier Pasquale Leone1, Gianmaria Calamita2, Mauro Gitto2
1Department of Biomedical Sciences, Humanitas University, Milan, Italy; Cardio Center, IRCCS Humanitas Research Hospital, Milan, Italy; Division of Cardiology, Montefiore Medical Center, New York, New York.
Insights
Sirolimus-coated balloons (SCB) and paclitaxel-coated balloons (PCB) show similar 12-month efficacy for coronary artery disease (CAD). This study found no significant difference in target lesion failure rates between SCB and PCB treatments.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Coronary artery disease (CAD) management increasingly utilizes drug-coated balloons.
- Sirolimus-coated balloons (SCB) and paclitaxel-coated balloons (PCB) are leading treatment options.
- Limited comparative data exists for SCB versus PCB in real-world CAD treatment.
Purpose of the Study:
- To compare the clinical outcomes of SCB versus PCB angioplasty in patients with CAD.
- To evaluate the 12-month target lesion failure (TLF) rate as a primary endpoint.
- To assess efficacy and safety in both de novo lesions and in-stent restenosis (ISR).
Main Methods:
- Observational, retrospective, investigator-driven cohort study at two Italian centers.
- Enrolled consecutive all-comer patients treated with SCB or PCB between 2018-2023.
- Used inverse probability of treatment weighting for comparative analysis; primary endpoint was 12-month TLF.
Main Results:
- 1320 patients (1569 lesions) were analyzed; 990 received SCB, 330 received PCB.
- Higher proportion of in-stent restenosis (ISR) in the SCB group (38% vs. 22%).
- 12-month TLF rates were similar: 10.5% for SCB vs. 8.2% for PCB (AHR: 1.00; 95% CI: 0.57-1.75).
- SCB and PCB showed comparable TLF rates for both ISR and de novo lesions.
- ISR was a significant predictor of TLF (AHR: 2.67; 95% CI: 1.74-4.10).
Conclusions:
- Sirolimus-coated balloons (SCB) and paclitaxel-coated balloons (PCB) demonstrate similar clinical efficacy and safety for treating coronary artery disease.
- The choice between SCB and PCB may not significantly impact major adverse cardiac events at 12 months.
- In-stent restenosis presents a higher risk for target lesion failure, irrespective of the drug-coated balloon used.
Abstract:
Sirolimus-coated balloons (SCB) have been recently introduced for treatment of coronary artery disease (CAD). Nonetheless, evidence on comparison of SCB versus paclitaxel-coated balloons (PCB) is scant. The aim of the study was to compare clinical outcomes after SCB versus PCB angioplasty for treatment of CAD. This observational, retrospective, investigator-driven cohort study was conducted at 2 Italian centers, and enrolled consecutive all-comer patients treated with SCB or PCB for de novo lesions or in-stent restenosis between 2018 and 2023. Analyses comparing SCB versus PCB included inverse probability of treatment weighting. Primary endpoint was 12-month rate of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization at time-to-first-event analysis. A total of 1320 patients (n = 1569 lesions) were enrolled, of which 990 patients (n = 1161 lesions) treated with SCB and 330 patients (n = 408 lesions) with PCB. The proportion of ISR was higher within SCB versus PCB groups (38% [n = 443] versus 22% [n = 89], p < 0.001). At a median follow-up of 347 [176-681] days, the 12-month event rate of TLF was similar with SCB versus PCB (10.5% [n = 93] vs. 8.2% [n = 21], adjusted hazard ratio [AHR]: 1.00; 95% confidence interval (CI): 0.57-1.75). When compared with PCB, SCB hazard rates for TLF were similar in both ISR (AHR: 0.89; 95% CI: 0.40-1.97) and de novo lesions (AHR:1.07; 95% CI: 0.52-2.20). ISR target lesion was a predictor of TLF (AHR: 2.67; 95% CI: 1.74-4.10). In conclusion, the current study, comparing drug-coated balloons equipped with the 2 most adopted drugs, suggests similar clinical efficacy and safety of SCB versus PCB for treatment of CAD.
