Clinical Performance and Safety of the Optima Non-compliant Percutaneous Transluminal Coronary Angioplasty Balloon in Contemporary Percutaneous Coronary Intervention: A Multicenter Real-World Study

BackgroundNon-compliant (NC) balloon catheters are widely used during percutaneous coronary intervention (PCI) for lesion preparation and stent optimization because they allow controlled high-pressure dilation.However, real-world clinical data describing the procedural performance and short-term clinical outcomes of NC balloon catheters across diverse patient and lesion characteristics remain limited.This study evaluated the observed procedural performance, device performance characteristics, and short-term clinical outcomes associated with the use of the Optima NC non-compliant percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (Translumina Therapeutics Private Limited, New Delhi, India) during routine PCI. MethodsThis multicenter, retrospective, single-arm observational study included patients aged ≥18 years who underwent PCI using at least one Optima NC PTCA balloon catheter at four cardiology centers in India between January and June 2024.Eligible patients had ≥80% coronary artery stenosis requiring PCI.The primary endpoint was procedural success, defined as successful balloon delivery, inflation, and retrieval without major procedural complications, together with achievement of final Thrombolysis in Myocardial Infarction (TIMI) grade III flow.Secondary endpoints included device success, operator-assessed device performance characteristics, and clinical outcomes through three months of follow-up. ResultsOf 216 patients screened, 196 (90.7%) were included in the final analysis, and 20 (9.3%) were excluded because of incomplete clinical or procedural information.The mean age was 59.20 ± 11.74 years, and 151 (77.0%) patients were male.Acute coronary syndrome was present in 191 (97.45%) patients, and multivessel disease in 111 (56.63%).The left anterior descending artery (LAD) was the most frequently treated vessel (112 (57.14%) patients).Procedural success was achieved in 193/196 (98.5%) procedures, while final TIMI grade III flow was achieved in 196/196 (100%) procedures.Device success was achieved in 193/196 (98.5%) procedures.No major adverse cardiac events (MACE) were reported during the index procedure or at discharge.During follow-up, one myocardial infarction (0.51%) was reported at one month, while one target lesion failure (TLF) (0.51%) and one cardiac death (0.51%) were reported at three months. ConclusionIn this multicenter real-world cohort, the Optima NC PTCA balloon catheter demonstrated high observed procedural and device success, with favorable operator-assessed performance and few clinical events during short-term follow-up.Given the retrospective single-arm design and absence of a comparator, these findings are descriptive and do not establish comparative efficacy, superiority, or long-term safety.Prospective comparative studies with larger populations and longer follow-up are warranted to further characterize the clinical performance of the device.