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MAPT (Mono Antiplatelet Therapy) as Regular Regimen After COBRA PzF™ NanoCoated Coronary Stent (NCS) Implantation
Luc Maillard1, François Vochelet1, Patrick Peycher1
1Service de Cardiologie, GCS ES Axium Rambot, 21, Avenue Alfred Capus, 13 090 Aix en Provence, France.
Insights
Clopidogrel mono antiplatelet therapy (MAPT) after COBRA PzF NCS implantation is safe and effective in high bleeding risk patients. One-year outcomes show no stent thrombosis and low major adverse cardiac events (MACE).
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- High bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) require careful antiplatelet therapy selection.
- The COBRA PzF Non-Coronary Stent (NCS) is a newer device for PCI procedures.
- Mono antiplatelet therapy (MAPT) with clopidogrel is being explored to reduce bleeding complications.
Purpose of the Study:
- To evaluate the safety and efficacy of COBRA PzF NCS implantation in HBR patients.
- To assess 1-year clinical outcomes in HBR patients treated with clopidogrel MAPT post-COBRA PzF NCS.
- To determine the rates of stent thrombosis and major adverse cardiac events (MACE).
Main Methods:
- Prospective, consecutive, observational study of HBR patients undergoing PCI with COBRA PzF NCS.
- Patients were discharged on clopidogrel MAPT.
- Primary endpoint: definite stent thrombosis at 1 month. Secondary endpoint: MACE at 12 months (cardiac death, MI, TLR).
Main Results:
- 77 patients (120 lesions) were enrolled; mean age 78.7 years.
- 0% definite stent thrombosis at 1 month (primary endpoint).
- 3.8% MACE at 12 months (including 3.8% TLR); no cardiac death or MI. No severe bleeding or stroke.
Conclusions:
- COBRA PzF NCS implantation with clopidogrel MAPT is feasible and safe in HBR patients.
- Excellent 1-year clinical outcomes observed, with no stent thrombosis and low MACE.
- Further validation in large randomized trials is warranted.
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 ± 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.
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