MAPT (Mono Antiplatelet Therapy) as Regular Regimen After COBRA PzF™ NanoCoated Coronary Stent (NCS) Implantation.

AIMS: To report procedural and 1-year outcomes following COBRA PzF NCS implantation in a routine daily setting with high bleeding risk (HBR) patients treated with clopidogrel as mono antiplatelet therapy (MAPT). METHODS: This is a prospective, consecutive, observational study in HBR patients who underwent PCI with COBRA PzF NCS and treated with clopidogrel alone at discharge. The primary endpoint was definite stent thrombosis at one month. The secondary endpoint was MACE (Cardiac Death, myocardial infarction (MI), target lesion revascularization (TLR)) at 12 months. RESULTS: From October 2015 to December 2018, 77 patients with 120 lesions were enrolled and treated. Mean age was 78.7 ±â€¯8.89 years, 58.5% men and 18.2% had ACS. Patients included had a minimum of 2.0 inclusion LEADERS FREE criteria. Angiographic success was achieved in all cases. The primary endpoint occurred in 0%, no stent thrombosis was occurred. MACE at 12-months (available for 52 patients) was 3.8% including cardiac death 0%, MI 0% and TLR 3.8%. No severe bleeding events (BARC3-5) or stroke or late stent thrombosis were noted. CONCLUSION: Clopidogrel as MAPT after COBRA PzF NCS implantation in HBR patients is feasible and an attractive option. One-year follow-up was associated with excellent clinical outcomes and should be confirmed with large randomised study. CONDENSED ABSTRACT: This is prospective registry of high bleeding risk patients treated with the COBRA PzF NCS and MAPT at discharge. The primary end point demonstrated no stent thrombosis. The rate of major cardiac adverse events (a composite of cardiovascular death, myocardial infarction and target lesion revascularisation) at 1 year was 3.8%. No severe bleeding events, stroke or late stent thrombosis were noted. One-year follow-up was associated with good clinical outcomes and compared favorably with current devices.

Immediate and 1-year follow-up with the novel nanosurface modified COBRA PzF stent.

BACKGROUND: The COBRA PzF coronary stent, which has a unique nano-coating of Polyzene-F, was developed to reduce the risk of stent thrombosis. AIMS: To report procedural and 1-year clinical outcomes following COBRA PzF coronary stent implantation in a real-world percutaneous coronary intervention (PCI) registry. METHODS: All patients assigned to treatment with the COBRA PzF in the GCS Axium Rambot Center, Aix-en-Provence, France between February 2013 to June 2014 were prospectively enrolled. RESULTS: Among 100 patients (71% men, mean±standard error age 71.4±11.0 years), 38% had acute coronary syndromes. The population was consistent with real-world experience and included patients with multiple co-morbidities and 26% with diffuse multivessel disease. A total of 151 lesions were treated with 166 stents, including 26% of lesions with a type B2 or C classification. Pre- and post-procedural quantitative coronary angiography analyses showed a mean acute gain of 2.2±0.2mm. Angiographic success was achieved in all cases. One-year follow-up was available for all patients and the target vessel failure (composite of all-cause mortality, myocardial infarction or target vessel revascularization) rate was 12%, including 2% mortality (end-stage cardiomyopathy), 5% myocardial infarction (five periprocedural myocardial infarctions with isolated troponin elevation without chest pain or Q waves) and 5% target lesion revascularization. There were no cases of definite stent thrombosis. CONCLUSION: The COBRA PzF stent was safe and effective in routine practice. One-year follow-up was associated with excellent clinical outcomes and compared favourably with current devices. These results are very promising in a real-world population of complex patients, and further study is warranted.