Everolimus-Eluting Stent (Espalier) in Coronary Artery Revascularization: A Retrospective, Investigator-Initiated, Multicenter Study

Abstract

Background: Drug-eluting stents (DESs) are key to percutaneous coronary intervention (PCI), with outcomes shaped by device, patient, and operator factors. The everolimus-eluting stent (EES, Espalier) was assessed in a multicenter, real-world study for safety and efficacy. The study evaluated the clinical outcomes, safety, and procedural success of the indigenous Espalier EES (Cognitive Technologies Pvt. Ltd.) in patients undergoing coronary revascularization at tertiary care centers in India.

Methods: This retrospective, multicenter study enrolled 402 adults (≥ 18 years) with native coronary lesions suitable for PCI. The primary endpoint was 12-month target lesion failure (TLF: cardiac death, target vessel myocardial infarction (MI), emergent coronary artery bypass grafting (CABG), or clinically driven target lesion revascularization (TLR)). Secondary endpoints included 6-month TLF, target vessel revascularization (TVR), stent thrombosis, and device/procedural success. Subgroup analyses were performed by age, sex, body mass index (BMI), vessel size, and clinical presentation.

Results: At 6 months, adverse events were minimal (0.50%), with no MI or stent thrombosis, one death (0.25%), and one TLF (0.25%). At 12 months, mortality remained 0.25%, with no MI or stent thrombosis, while TVR occurred in 1.49% and TLF in 1.74% of patients. Subgroup analyses revealed higher event rates in older patients (≥ 70 years), those with unstable angina, abnormal electrocardiogram (ECG)/echocardiographic findings, and patients with two comorbidities. Device and procedural success were achieved in all cases (100%), with no failures recorded.

Conclusions: The Espalier EES demonstrated high procedural success and low adverse event rates at 12 months, with slightly higher risks observed in elderly and high-risk patients.