Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents

Study Overview
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Brief Summary
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Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different lesions. Clinical outcome of patients with previously unknown (silent) diabetes and prediabetes is of increasing interest since the latter group has recently shown to be associated with a significant risk of adverse cardiovascular events after treatment with contemporary DES. Outcome data in a population of high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes, would be of great interest, but such data are not available yet. In addition, there is a lack of data in a general all-comer population. Therefore, the COASTLINE study will primarily assess the safety and efficacy of the Xience Sierra stent in a general all-comer population as well as a high-risk all-comer population.

Official Title
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Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)

Conditions
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Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis

Intervention / Treatment
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* Device: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years requiring PCI and treated with Xience Sierra capable of providing informed consent Exclusion Criteria: known intolerance to components of the study DES or antithrombotic/anticoagulant therapy planned elective surgery necessitating interruption of dual antiplatelet therapy (DAPT) < 3 months patient is known to be pregnant, unlikely to adhere to follow-up or expected live < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All-comer patients requiring PCI<br>All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES | Device: Percutaneous coronary intervention<br>* PCI for treatment of coronary or bypass graft lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF) at 1-year follow up in complex all-comers | TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization. | 1 year | 
| Target lesion failure (TLF) at 2-year follow up in all-comers | TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TVF at 2 year follow up |  | 2 year | 
| Death | any/cardiac/non-cardiac | up to 3 year | 
| Myocardial infarction | target vessel related/any/periprocedural | up to 3 year | 
| Clinically indicated target vessel revascularization |  | up to 3 year | 
| Clinically indicated target lesion revascularization |  | up to 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Target vessel failure, Drug-eluting stent, Durable polymer, Everolimus, All comers population, High-risk all comers, Coronary artery disease