DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity

Summary

Rationale:

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

Objective:

To investigate whether the clinical outcome is similar after implantation of the Promus Element versus the Resolute Integrity stent (non-inferiority hypothesis).

Study design:

Multicenter, prospective, randomized single-blinded study.

Study population:

Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included.

Intervention:

In patients who are eligible for DES implantation, the type of DES implanted will be randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study, both DES will also be used in routine clinical practice.

Main study endpoints:

The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI, or clinically driven target vessel revascularization. Further secondary clinical and angiographic endpoints will be investigated, defined in accordance with suggestions of the Academic Research Consortium (ARC). Of note, the angiographic assessment is based on clinically indicated projections only and results in no additional x-ray exposure. There is no routine angiographic follow-up. If angiographic data are available in patients who undergo symptom-driven re-catheterization, we will analyze these data to get insight into the mechanisms of potential DES restenosis.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the routine clinical treatment. As a consequence, the risks of this trial do not exceed the risks of any routine PCI procedure.

Conditions

• Coronary Artery Disease
• Angina Pectoris
• Unstable Angina Pectoris
• Acute Coronary Syndrome
• Coronary Stenosis
• Coronary Restenosis

Interventions

DEVICE

Resolute Integrity®

Biolinx-zotarolimus coating on a chobalt-cromium alloy stent platform that has a novel sinusoidal design.

DEVICE

Promus Element®

fluoropolymer-everolimus coating on a novel stent platform made from a platinum-chromium alloy

Sponsors & Collaborators

• Thorax Centrum Twente

  lead OTHER

Principal Investigators

• Clemens von Birgelen, MD,PhD,Prof · Thorax Centrum Twente

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-30

Primary Completion

2013-05-31

Completion

2017-06-30

Countries

• Netherlands

Study Locations