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

NCT ID: NCT04475380

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1757 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-21
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Percutaneous coronary intervention

Intervention Type: DEVICE

PCI for treatment of coronary or bypass graft lesions

Interventions

Percutaneous coronary intervention

PCI for treatment of coronary or bypass graft lesions

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Foundation of Cardiovascular Research and Education Enschede

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thoraxcentrum Twente

Enschede, , Netherlands

Haga Ziekenhuis

The Hague, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 41230396 (View on PubMed)

Other Identifiers

COASTLINE

Identifier Type: -

Identifier Source: org_study_id