NCT02854423

Brief Summary

Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. BP-BES with DP-EES have been directly compared in 2 randomized trials, showing no differences between the two devices in all-comer patients during long-term follow-up. It is unknown whether these results are consistent in real-world patients with diabetes mellitus during long-term follow-up. To evaluate the safety and efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes mellitus during long-term follow-up. Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation were included in a multicenter registry between January 2007 and May 2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR). Secondary endpoints are the individual components of the primary endpoint as well as definite stent thrombosis (ST).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

5.3 years

First QC Date

February 1, 2016

Last Update Submit

July 29, 2016

Conditions

Percutaneous Coronary InterventionDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • major cardiac adverse events

    a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR)

    4 years

Secondary Outcomes (4)

  • rate of definite stent thrombosis in revascularized patients according with ARC definition

    4 years

  • Rate of composite of all-cause death in all participants

    4 years

  • Rate of myocardial infarction according with definition of MI type 1in all participants

    4 years

  • Rate of target-vessel revascularization (TVR) in all participants

    4 years

Study Arms (2)

biodegradable polymer

Device: percutaneous coronary interventions

durable-polymer

Device: percutaneous coronary interventions

Interventions

percutaneous coronary interventionsDEVICE

Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation

biodegradable polymerdurable-polymer

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive diabetic patients with coronary artery diseases undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation between January 2007 and May 2012

You may qualify if:

  • age \> 18 years
  • diabetes mellitus
  • percutaneous coronary interventions with biolimus eluting stent or everolimus eluting stent implantation
  • signed informed consent

You may not qualify if:

  • planned procedure requiring antiplatelet therapy withdrawal within 12 months from index coronary angioplasty
  • patients with contraindication to dual antiplatelet therapy (aspirin plus ticlopidine or clopidogrel)
  • known allergy to stent drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

August 3, 2016

Study Start

January 1, 2007

Primary Completion

May 1, 2012

Study Completion

January 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-07