Drug-eluting balloon angioplasty: redefining percutaneous coronary intervention

Abstract

Background: Drug-eluting balloon (DEB) angioplasty has emerged as an effective alternative to stent-based coronary revascularization, offering comparable efficacy without the long-term complications associated with permanent metallic implants. Sirolimus-based drug-coated balloon platforms offer distinct mechanistic advantages through inhibition of the mammalian target of rapamycin (mTOR) pathway, enabling selective suppression of smooth muscle cell proliferation while preserving endothelial integrity. Herein, we report the clinical outcomes of a prospective cohort of 59 patients treated with sirolimus-DEB angioplasty.

Methods: We prospectively enrolled 59 consecutive patients undergoing sirolimus-Drug eluting balloon angioplasty for coronary artery disease at a single center over a two-year period (2023-2025). Primary endpoints were technical and procedural success. Secondary endpoints included major adverse cardiovascular events (MACE), restenosis, and target lesion revascularization (TLR) at 6-12 months of follow-up.

Results: The mean age of the cohort was 59.1±10.7 years; 40 (67.8%) were male and 19 (32.2%) were female, with male predominance. Clinical presentations included acute coronary syndromes in 29 (49.2%) and chronic coronary disease in 30 (50.8%). Sirolimus DEB was deployed in 56 of 59 cases (94.9%). Technical and procedural success was achieved in 59 of 59 cases (100%), with all procedures achieving Thrombolysis in myocardial infarction 3 flow and residual stenosis <30%. In-hospital MACE occurred in 1 of 59 patients (1.7%), attributable to refractory cardiogenic shock in the setting of anterior myocardial infarction with severe left ventricular dysfunction; no procedure-related mortality or major bleeding was recorded. At 6-12-month follow-up, available in 56 of 59 patients (94.9%), 53 of 56 (94.6%) were symptom-free with zero TLR and zero late MACE.

Conclusion: Sirolimus-eluting balloon angioplasty demonstrates excellent safety and efficacy in this single-center prospective cohort. The 59/59 (100%) technical success rate, 58/59 (98.3%) uneventful procedural course, and 1/59 (1.7%) MACE rate compare favorably with published benchmarks and support the continued adoption of sirolimus-based drug-coated balloon technology for percutaneous coronary revascularization in appropriately selected patients.