A paclitaxel-coated balloon using urea as excipient showed similar 2-year outcomes, including all-cause mortality (8.7% vs 9.4%), compared to other contemporary drug-coated balloons in ACS.
Cohort (n=4,163)
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Does a paclitaxel-coated balloon using urea as an excipient improve clinical outcomes compared to other contemporary drug-coated balloons in patients with acute coronary syndrome?
In a nationwide real-world registry of patients with acute coronary syndrome, a paclitaxel-coated balloon using urea as an excipient demonstrated similar 2-year clinical outcomes compared to other contemporary drug-coated balloons.
Tasa de eventos absoluta: 8.7% vs 9.4%
Abstract Background In acute coronary syndrome (ACS), percutaneous coronary intervention (PCI) is the standard treatment for revascularization. Stent apposition and sizing remain a significant challenge in ACS as vasospasm often complicates PCI.The use of drug-coated balloon (DCB) has emerged as a compelling alternative, avoiding the risk of mispositioned stents. There are a variety of DCB available differing in their drug type, coating technology and balloon design, but there is limited data comparing different types of DCB for ACS. Purpose We aimed to compare a paclitaxel-coated balloon using urea as excipient (the Study DCB) with other contemporary used DCB (Other DCB) for patients presenting with ACS. Methods We conducted a nationwide observational cohort study by using the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). All patients in Sweden undergoing PCI are included in SCAAR. For this analysis, SCAAR was used to identify patients presenting with ACS and treated with DCB in Sweden between 2nd of August 2021 – 16th of May 2024. DCB used less than 100 times during the study period were excluded as were patients treated with use of different types of DCB during the same procedure. A separate analysis was used to assess outcome for solely patients presenting with ST-segment elevation myocardial infarction (STEMI). Outcome was assessed with Kaplan-Meier estimates and multivariable Cox proportional regression analysis. Results For this study, 1097 patients undergoing PCI using the study DCB and 3066 patients with Other DCB were included. The mean age in the study DCB group and Other DCB group was 71.0 vs 72.9 years, 75.6% vs 76.7% were male, 45.5% vs 49.1% had a previous myocardial infarction and 52.9% vs 50.2% had left main disease and/or multivessel disease on angiography. For the Study DCB and Other DCB respectively, the most common indication was NSTEMI (61.2% vs 60.3%) followed by unstable angina (20.4% vs 18.1%) and STEMI (18.4% vs 21.6%). After a 2-year follow-up, for the Study DCB and Other DCB respectively, the event rate of all-cause mortality was 8.7% vs 9.4%, myocardial infarction was 7.3% vs 9.2%, new revascularization with PCI was 17.0% vs 15.8%, target lesion definite thrombosis was 1.2% vs 1.6%, target lesion revascularization was 10.1% vs 9.9% and target vessel revascularization was 13.8% vs 12.8%. No statistically significant difference was observed after adjusting for confounders. For STEMI patients, the results were in line with the ACS analysis, showing similar outcome for the Study DCB and Other DCB. Conclusion In this comprehensive nationwide analysis investigating the use of DCB in ACS and STEMI, the Study DCB was associated with a similar outcome compared to other, contemporary DCB. These results are important for clinicians who are considering DCB in in ACS where evidence is limited to date.Figure 1.ACS outcome Figure 2.STEMI outcome
Koch et al. (Sat,) conducted a cohort in Acute coronary syndrome (n=4,163). Paclitaxel-coated balloon using urea as excipient vs. Other contemporary drug-coated balloons was evaluated on All-cause mortality. A paclitaxel-coated balloon using urea as excipient showed similar 2-year outcomes, including all-cause mortality (8.7% vs 9.4%), compared to other contemporary drug-coated balloons in ACS.