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

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Percutaneous coronary interventions (PCIs) have advanced, improving patient outcomes.
• Real-world data on ultrathin-strut drug-eluting stents (DES) is crucial, especially considering cost and accessibility.
• Indigenous stent development is vital for healthcare accessibility.

Purpose of the Study:

• To evaluate the 1-year safety and efficacy of the indigenous Pristine+™ everolimus-eluting cobalt-chromium stent (EES).
• To assess the performance of an ultrathin strut (60-µm) DES in a real-world patient population.
• To determine the incidence of major adverse cardiac events (MACE) at 1 year.

Main Methods:

• A prospective, single-arm, multicenter registry study.
• Enrolled 1,088 patients undergoing PCI with Pristine+™ EES.
• Primary endpoint: 1-year incidence of MACE (cardiac death, myocardial infarction, stent thrombosis).

Main Results:

• The study population had a high prevalence of cardiovascular risk factors.
• At 1 year, the Kaplan-Meier incidence of MACE was 2.89% (40 events).
• Low rates of cardiac death (1.65%), myocardial infarction (1.19%), and stent thrombosis (0.83%) were observed. No clinically indicated target-lesion revascularization (CI-TLR) occurred.

Conclusions:

• The Pristine+™ ultrathin-strut EES demonstrated favorable 1-year clinical outcomes.
• Low MACE rates and absence of CI-TLR suggest good safety and efficacy in real-world use.
• This indigenous DES offers a promising option for PCI procedures.