Drug-eluting stents (DES) have revolutionized coronary interventions, but their limitations, particularly in-stent restenosis (ISR) and stent thrombosis, remain significant concerns. To address these challenges, drug-coated balloons (DCBs) have emerged as a promising alternative strategy. While DCBs have established efficacy in treating ISR, their role in de novo lesions remains uncertain. The current prospective, single-center observational study aims to evaluate the safety and efficacy of DCB in various lesion subsets, including de novo lesions, to expand the understanding of its clinical applications. The primary objectives of this study are:1. To assess the acute procedure success of DCB in de novo lesions and ISR.2. To evaluate the 6-month clinical outcomes, including Major Adverse Cardiac Events (MACE), Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR).3. To investigate the efficacy and safety of DCB in different lesion subsets, such as small vessel disease and large vessel disease.

Study Design and Population This prospective, single-center observational study was conducted between January 2023 and January 2024, following institutional ethics committee approval. Consecutive patients undergoing treatment with drug-coated balloons (DCBs) during this period were included. Data Collection Demographic details, clinical presentation (Acute Coronary Syndrome (ACS) or stable angina), and lesion characteristics and procedure details  were documented as follows: 1. Lesion type (In-Stent Restenosis (ISR) or de novo)2. Vessel size (small: ≤ 2.75 mm, large: >2.75 mm) 3. Lesion preparation method (non-compliant balloon, cutting balloon, IVL, etc.)4. Intracoronary imaging usage5. Pre-and post-DCB dissection type6. DCB type (paclitaxel-coated or sirolimus-coated) Outcome Measures Acute procedure success was defined as: - Residual stenosis <20% angiographically- No flow-limiting dissections- No bailout stenting Follow-up Patients were clinically followed up for 6 months. Major Adverse Cardiac Events (MACE), Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR) were assessed at 1 month and 6 months.

During the study period, a total of 36 lesions were treated with drug-coated balloons (DCB) in 32 patients. The mean age of the patients was 57.8 ± 9.05 years, with 25 (78.1%) males and 7 (21.9%) females. Hypertension was present in 24 (75%) patients, and diabetes was present in 23 (71.9%) patients. Regarding clinical presentation, 28 (87.5%) patients presented with acute coronary syndromes (ACS), and 4 (12.5%) presented with stable angina. The mean left ventricular ejection fraction (LVEF) was 53.0 ± 9.0%. Out of the 32 vessels treated, 19 (59.4%) were denovo vessels, 10 (31.3%) were in-stent restenosis (ISR), and 3 (9.4%) were saphenous venous grafts (SVG). Among the 19 denovo vessels, 15 (46.9%) were small vessels, and 4 (12.5%) were large vessels. Lesion distribution showed: - 13 (36.1%) in the left anterior descending (LAD) artery- 6 (16.6%) in the obtuse marginal (OM) artery- 5 (13.8%) in the left circumflex (LCX) artery- 3 (8.3%) in each diagonal, Ramus, right coronary artery (RCA), and SVG grafts A non-compliant (NC) balloon of size 1:1 was used in all patients for lesion preparation. In 7 (21.9%) patients, a combination of NC balloon and cutting balloon was used, and in one patient, intra vascular lithotripsy (IVL) was used. Intravascular imaging, including intravascular ultrasound (IVUS) and optical coherence tomography (OCT), was used for procedural guidance in 8 (25%) patients. Sirolimus-coated DCB was applied in 24 (66.6%) lesions, and paclitaxel-coated DCB was applied in 12 (33.3%) lesions. The average length of DCB used per patient was 27.2 ± 14.62 mm. The acute procedural success was achieved in all cases, with no flow-limiting dissections or bailout stenting. There were no major adverse cardiac events (MACE), target lesion revascularization (TLR), or target vessel revascularization (TVR) at 1 month and 6 months of clinical follow-up.

This prospective, single-center observational study demonstrates the efficacy and safety of drug-coated balloons (DCB) in various lesion subsets, including in-stent restenosis (ISR), denovo vessels (both small and large), and patients with acute coronary syndromes (ACS) and chronic stable angina.