ArticleTherapeutic advances in cardiovascular disease
Two-year real-world outcomes of coronary drug-coated balloon therapy: a retrospective comparative study of sirolimus- and paclitaxel-coated devices.
Article in Therapeutic advances in cardiovascular disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDrug-coated balloons (DCBs) represent a "leave-nothing-behind" strategy in percutaneous coronary intervention (PCI), particularly for small vessel disease and in-stent restenosis. However, long-term comparative real-world data between paclitaxel- and sirolimus-coated balloons remain limited, and the impact of lesion characteristics on outcomes is not fully understood.
objectivesThis study aimed to evaluate the 2-year clinical outcomes of coronary DCB therapy and compare the performance of sirolimus- and paclitaxel-coated balloons in a real-world cohort.
designSingle-center retrospective cohort study.
methodsA total of 92 consecutive patients who underwent DCB-based PCI between January 2020 and December 2022 were retrospectively analyzed. Patients were grouped according to DCB type (sirolimus vs paclitaxel). The primary endpoints were restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and TLR. Secondary outcomes included changes in angina frequency and severity, and selected laboratory parameters. Outcomes were assessed over 24-month follow-up period.
resultsThe overall 2-year restenosis rate was 13.0%, with TLR occurring in 7.6% of patients, and MACE in 9.8%. Significant improvements in angina frequency and severity were observed at 3 months (both
conclusionIn this real-world cohort, coronary DCB therapy was associated with acceptable 2-year clinical outcomes and significant symptom improvement. Although sirolimus-coated balloons showed numerically favorable results, no definitive conclusions regarding superiority can be drawn. Larger prospective studies are needed to confirm these findings and to better define optimal patient and lesion selection.
trial registrationNot applicable.
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