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Five-Year Clinical Outcomes of the COBRA Polyzene F NanoCoated Coronary Stent System
Donald E Cutlip1, Rajiv Jauhar2, Perwaiz Meraj2
1Cardiology Division, Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research and Harvard Medical School, Boston, MA, United States of America.
Insights
The COBRA Polyzene F™ NanoCoated Coronary Stent System showed sustained safety and effectiveness over 5 years for de novo coronary lesions. Incident rates for major adverse clinical events, myocardial infarction, and target lesion revascularization remained low.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- The COBRA Polyzene F™ NanoCoated Coronary Stent System (PzF coated stent) showed positive 9-month outcomes.
- Late clinical results beyond 9 months were previously unreported.
- Assessing long-term safety and effectiveness is crucial for coronary stent technologies.
Purpose of the Study:
- To evaluate the late safety and effectiveness of the PzF coated stent.
- To assess outcomes in patients with de novo coronary artery lesions treated with the PzF stent.
- To extend the understanding of PzF stent performance beyond the initial 9-month follow-up.
Main Methods:
- A non-randomized, prospective clinical trial was conducted.
- 296 patients with de novo coronary artery lesions were enrolled and followed for 5 years.
- Primary endpoint was target vessel failure at 9 months; secondary endpoints included MACE, TLR, and stent thrombosis up to 5 years.
Main Results:
- 290 patients (98%) were evaluable at 5 years.
- By 5 years, cumulative MACE occurred in 21.3%, cardiac death in 4.2%, MI in 8.6%, and TLR in 12.0%.
- Between years 1 and 5, incident MACE rates were low, with no definite or probable stent thromboses observed.
Conclusions:
- The PzF coated stent demonstrated continued safety and effectiveness up to 5 years.
- Low incident rates of MACE, MI, TLR, and stent thrombosis were observed between 1 and 5 years.
- The PzF stent offers a safe and effective treatment option for de novo coronary artery lesions in the long term.
Background/Purpose:
The COBRA Polyzene F™ NanoCoated Coronary Stent System (PzF coated stent) stent demonstrated favorable clinical outcomes at 9 months but late results have not been reported. We sought to assess the late safety and effectiveness of the PzF coated stent for treatment of de novo coronary artery lesions.
Methods:
Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a non-randomized, prospective clinical trial and followed for 5 years. The primary endpoint was target vessel failure (TVF, cardiac death, myocardial infarction [MI], or clinically-driven target vessel revascularization [TVR]) at 9 months. Secondary endpoints included major adverse clinical events (MACE, cardiac death, MI, or clinically driven TLR), clinically driven target lesion revascularization (TLR) and definite or probable stent thrombosis during 5-year follow-up. Endpoints at 5 years were analyzed as cumulative incidence accounting for competing risk of death.
Results:
Of 296 enrolled patients, 290 (98%) were evaluable at 5 years. By 5 years, MACE had occurred in 61 (21.3%), cardiac death in 11 (4.2%), MI in 25 (8.6%), and TLR in 34 (12.0%) subjects. Between follow-up years 1 and 5, a first MACE occurred in 17 (6.2%), including 10 (4.0%) cardiac death, 4 (1.6%) MI, and 7 (2.9%) TLR events. There were no definite or probable stent thromboses.
Conclusions:
The PzF coated stent demonstrated continued safety and effectiveness through 5 years with low to very low incident rates of MACE, MI, TLR and stent thrombosis between 1 and 5 years after stent placement.
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