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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease; Angina Pectoris; Acute Coronary Syndrome; Angina, Unstable; Coronary Stenosis; Coronary Restenosis
• Intervention / Treatment: Device: Percutaneous coronary intervention

• Study Type: Observational
• Enrollment (Estimated): 1757

Contacts and Locations

Study Locations

• Netherlands
  • Den Haag, Netherlands
    • Haga ziekenhuis
  • Enschede, Netherlands
    • Thoraxcentrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All-comers. Patients for elective PCI or acute PCI

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All-comer patients requiring PCI; 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; PCI for treatment of coronary or bypass graft lesions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Foundation of Cardiovascular Research and Education Enschede
• Collaborators: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease; Everolimus; Drug-eluting stent; Durable polymer; All comers population; High-risk all comers; Target vessel failure
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Infarction; Chest Pain; Myocardial Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: COASTLINE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes