Pristine+™ Everolimus-Eluting Cobalt-Chromium Coronary Stent System: A Prospective, Multicenter Registry

Abstract

Background: Recent advances in percutaneous coronary interventions (PCIs) have substantially improved clinical outcomes. Generating real-world evidence on the 1-year outcomes of ultrathin-strut drug-eluting stents (DES) remains important, particularly in healthcare settings where cost and accessibility may influence stent selection.

Methods: A prospective, single-arm, multicenter registry was conducted to evaluate the 1-year safety and efficacy of an indigenous everolimus-eluting cobalt–chromium stent (EES) (Pristine+™ - Make: Relisys Medical Devices Limited, India) featuring an ultrathin strut (60-µm) design. The primary endpoint was the 1-year incidence of major adverse cardiac event (MACE) defined as a composite of cardiac death (CD), myocardial infarction (MI), and stent thrombosis (ST).

Results: The study enrolled 1,088 patients, predominantly male (78.9%). High prevalence of diabetes mellitus (34.7%), hypertension (63.9%), and smoking history (25.7%) was noted. The mean age was 58.6 ± 10.6 years, with 69.9% between 36 and 65 years. A total of 95.9% completed the 1-year follow-up. At 1-year, the Kaplan–Meier incidence of MACE was 2.89% (40 events), comprising 18 CD (1.65%), 13 MI (1.19%), and nine ST (0.83%). All-cause mortality was 2.3% (25 events). One target-vessel myocardial infarction (TV-MI; 0.09%) was reported and no clinically indicated target-lesion revascularization (CI-TLR) events occurred.

Conclusion: This study demonstrated favorable 1-year clinical outcomes with Pristine+™, reflected by low rates of MACE and no CI-TLR during the 1-year follow-up. A total of 1,386 Pristine+ EES were implanted in this study.