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

NCT04475380 | Completed FDA Device

• 1 other identifier: COASTLINE
• Study Type: observational
• Target: 1,757
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• TVF at 2 year follow up

  2 year

• Death

  up to 3 year

• Myocardial infarction

  up to 3 year

• Clinically indicated target vessel revascularization

  up to 3 year

• Clinically indicated target lesion revascularization

  up to 3 year

Study Arms (1)

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

Interventions

Percutaneous coronary intervention DEVICE

PCI for treatment of coronary or bypass graft lesions

All-comer patients requiring PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All-comers. Patients for elective PCI or acute PCI

You may qualify if:

• \>18 years
• requiring PCI and treated with Xience Sierra
• capable of providing informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: collaborator
• Foundation of Cardiovascular Research and Education Enschede: lead

Study Sites (2)

Thoraxcentrum Twente

Enschede, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

Related Publications (1)

• van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Anthonio RL, Zocca P, Hartmann M, Stoel MG, de Man FHAF, Linssen GCM, Doggen CJM, van der Heijden LC, Kok MM, von Birgelen C. Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk. Eur Heart J Open. 2025 Oct 21;5(6):oeaf140. doi: 10.1093/ehjopen/oeaf140. eCollection 2025 Nov.

  PMID: 41230396 DERIVED

MeSH Terms

Conditions

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

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: September 21, 2018
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

NL (2)