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

Active, not recruiting

• Conditions: Acute Coronary Syndrome; Angina Pectoris; Coronary Artery Disease; Coronary Stenosis; Angina, Unstable; Myocardial Infarction; Coronary Restenosis
• Interventions: Device: Percutaneous coronary intervention

• Registration Number: NCT04475380
• Lead Sponsor: Foundation of Cardiovascular Research and Education Enschede

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-21
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-17
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1757

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All-comer patients requiring PCI	Percutaneous coronary intervention	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinically indicated target vessel revascularization	up to 3 year
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 lesion revascularization	up to 3 year

Trial Locations

Locations (2)

Haga Ziekenhuis; 🇳🇱 Den Haag, Netherlands

Thoraxcentrum Twente; 🇳🇱 Enschede, Netherlands