Clinical trial NCT04475380: Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Official title: Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Myocardial Infarction
Coronary Artery Disease
Coronary Stenosis
Coronary Restenosis
Keywords: Drug-eluting stent
Durable polymer
Everolimus
All comers population
High-risk all comers
Target vessel failure
Coronary artery disease
Lead sponsor: Foundation of Cardiovascular Research and Education Enschede
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2020-07-17
Enrollment: 1757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All-comers. Patients for elective PCI or acute PCI

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.


Eligibility criteria: 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

Primary outcomes:
measure: Target vessel failure (TVF) at 1-year follow up in complex all-comers
timeFrame: 1 year
measure: Target lesion failure (TLF) at 2-year follow up in all-comers
timeFrame: 2 year
Secondary outcomes:
measure: TVF at 2 year follow up
timeFrame: 2 year
measure: Death
timeFrame: up to 3 year
measure: Myocardial infarction
timeFrame: up to 3 year
measure: Clinically indicated target vessel revascularization
timeFrame: up to 3 year
measure: Clinically indicated target lesion revascularization
timeFrame: up to 3 year
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Enschede
country: Netherlands
facility: Thoraxcentrum Twente
Study officials:
References: