The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting

Summary

The superiority of a percutaneous coronary intervention (PCI) by one stent over another in terms of clinical outcome is usually documented in large randomized controlled trials (RCT). Although generated from selected study populations these data form the basis for evidence based practice (EBP) in the entire population of patients considered for coronary intervention. An inherent limitation of this approach is that study populations differ significantly from all comers in terms of patient characteristics and prognosis undermining the foundation for extrapolation of trial results to all comers. Furthermore, other trials are based on a "one-fits-all" concept, while the benefits of an "individual-tailored" approach that might be superior, is not investigated.

The Purpose of the current study is to

* Compare clinical outcome between several CE marked drug eluting stents
* Compare clinical outcome between several CE marked bare metal stents
* Compare clinical outcome in all comers with that of the selected study population of RCT's
* Evolve methods to compare clinical outcomes between the generalized "one-fits-all" versus the individualized or "individual-tailored" stent selection approaches

The Method employed is

* All comer PCI registry - single centre
* Randomisation of all eligible patients within the registry to one of several study stent
* Quality assurance in non-randomized population within the registry by periodical alternating the institutional standard stent
* Continuous follow up of all patients included the registry by means of systematic event detection and classification by an independent safety and end point committee
* Assessment of effects on quality of life by heart and health questionnaires

Outcome Measures

Primary endpoints:

* Composite of cardiac death, acute myocardial infraction and target vessel revascularisation
* Stent thrombosis
* A specifically developed Treatment Failure Rate classification

Secondary outcome measures include each of the above, target lesion revascularisation and total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.

Tertiary outcome measure is self reported quality of life based on health questionnaires on general health and cardiac symptoms.

Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an absolute difference of 5%), P\< 5%, Power \> 80% =\> 900 patients in each of two treatment arms.

Prespecified Analysis include

1. The MACE rates between stent types
2. The Stent thrombosis rates between stent types
3. The Treatment failure rates between stent types
4. The randomized population versus non-randomized population
5. The individualized versus the generalized Population
6. QOL between stent types

Conditions

• Ischemic Heart Disease

Interventions

DEVICE

Biomatrix drug eluting stent

Biomatrix drug eluting stent

Sponsors & Collaborators

• Zealand University Hospital

  lead OTHER

Principal Investigators

• Anders M Galløe, Md.Ph.D. · Zealand University Hospital

• Steen Carstensen, MD · Zealand University Hospital

• Ole Havndrup, MD · Zealand University Hospital

• Lars Kjøller-Hansen, MD · Zealand University Hospital

• Gunnar VH Jensen, MD · Zealand University Hospital

• Jørgen Jeppesen, MD · Glostrup University Hospital, Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2020-03-31

Completion

2021-03-31

Countries

• Denmark

Study Locations