Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Coronary Artery Disease, Coronary Restenosis, Coronary Stenosis, Myocardial Infarction
Conditions
Keywords
Drug-eluting stent, Durable polymer, Everolimus, All comers population, High-risk all comers, Target vessel failure, Coronary artery disease
Brief summary
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.
Interventions
DEVICEPercutaneous coronary intervention
PCI for treatment of coronary or bypass graft lesions
Sponsors
Foundation of Cardiovascular Research and Education Enschede
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel failure (TVF) at 1-year follow up in complex all-comers | 1 year | TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization. |
| Target lesion failure (TLF) at 2-year follow up in all-comers | 2 year | TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TVF at 2 year follow up | 2 year | — |
| Death | up to 3 year | any/cardiac/non-cardiac |
| Myocardial infarction | up to 3 year | target vessel related/any/periprocedural |
| Clinically indicated target vessel revascularization | up to 3 year | — |
| Clinically indicated target lesion revascularization | up to 3 year | — |
Countries
Netherlands
Outcome results
None listed