Safety and performance of the EverPro^TMeverolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario

Abstract

BACKGROUND The EverPro TM (Sahajanand Laser Technology Ltd., India) everolimus-eluting coronary stent system (EES) is a second-generation drug-eluting stent with a biodegradable polymer. AIM To determine the safety and performance of the EverPro TM EES in patients with coronary artery disease (CAD) during a 1-year clinical follow-up. METHODS This observational, retrospective, single-center study enrolled patients who had been implanted with the EverPro TM stent between June 1, 2018 and January 31, 2019, and had completed a 1-year follow-up period after the index procedure. The primary clinical endpoint was major adverse cardiac events (MACE) at 6 mo defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary endpoints were the incidence of TLR at 1, 6 and 12 mo follow-up, MACE at 1 and 12 mo follow-up, and stent thrombosis up to 1 year after the index procedure. RESULTS The study population comprised 77 patients (98 lesions). A total of 37 (48.1%) patients had comorbid hypertension. In total, 26 (33.8%) patients presented with ST segment elevation MI and 10.4% patients with non-ST segment elevation MI. Treated lesions were located mainly in the left anterior descending artery (49%) followed by the right coronary artery (29.6%), left circumflex (12.2%) and obtuse marginal (9.2%) arteries. The majority of patients were with single-vessel disease (79%), 22.2% of lesions had a mild to severe thrombus load, and 94.9% were American College of Cardiology/American Heart Association type B or C. De novo stenting was performed in 96.9% of patients and 3% were treated for in-stent restenosis. Procedural success was attained in all patients. In-hospital or follow-up MACE and stent thrombosis were not reported during the 1-year follow-up period. CONCLUSION These findings suggest that the EverPro TM EES is a safe and effective treatment option with no MACE or stent thrombosis reported during the 1-year study period in patients with CAD.

Core outcome set for clinical trials of stent implantation in coronary heart disease -- a systematic review and mixed-method consensus study

“…It is possible that the application of drug-eluting or bioabsorbable stent, the new generation of stent, has significantly reduced stent thrombosis, which was considered to be a criticism of metal stents. [32][33][34] This may be similar to those outcomes whose importance would change along with the progress of stent technology. Therefore, this core set will be updated as new evidence emerges.…”

Biodegradable polymer everolimus-eluting stents versus contemporary drug-eluting stents: a systematic review and meta‑analysis

“…Compared with contemporary DP-DES, BP-DES have comparable clinical outcomes 5 , 6 . The potential influence of other factors on the outcomes, such as polymer coatings composition and scaffolds strut thickness 7 , has been the focus of controversy 8 , 9 . It is worth noting that the strut thickness of existing BP-DES varies significantly, which may be partly the cause that BP-DES fails to show superiority over DP-DES 10 , 11 .…”

Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

“…Percutaneous coronary intervention (PCI) is an increasingly performed revascularization modality for the treatment of coronary artery disease (CAD) [ 1 ]. PCI with drug-eluting stent (DES) implantation has become a standard therapeutic procedure for patients with CAD [ 2 ].…”