The Real-World Endeavor Resolute versus XIENCE V Drug-Eluting SteNt Study in TwentE

Rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to significant reduction in morbidity but not in mortality.
Second generation DES were developed in an effort to further decrease morbidity and also to decrease mortality.
In our center, two CE-certified second generation DES (Endeavor Resolute stent and XIENCE V stent) are now used in daily clinical routine. There are no data that indicate an advantage of one of these DES over the other (e.g., for certain indications); therefore, we currently make our choice of DES simply by chance.

Objective: To investigate whether the clinical outcome is similar after the implantation of the Endeavor Resolute stent versus the XIENCE V stent (non-inferiority test).

Study design: Single center prospective randomized single-blinded study.

Study population: Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included with the exception of ST –elevation myocardial infarction.

Intervention: In patients who will receive a DES anyway, we will randomize the type of DES implanted (Endeavor Resolute stent vs. XIENCE V stent). Both DES are already used in our routine PCI procedures. At this time, no data are available that may suggest the superiority of one of the above-mentioned DES over the other.

Main study endpoints: The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is any target vessel revascularization, death, or MI which is attributable to the target vessel or not attributable to another vessel. Further secondary clinical and angiographic endpoints will be investigated and have been defined in accordance with the consensus paper of the Academic Research Consortium (ARC) as published in 2007. 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. However, 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 restenosis. In addition, we will analyze clinical intravascular ultrasound (IVUS) images that may be available in a subpopulation of patients (in whom the operator for clinical reasons decides to use IVUS guidance). Of note, there will be no additional IVUS examinations (i.e., no IVUS examination for research purpose only) for this study, but we will analyze the IVUS data from clinical routine where they are available.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the routine treatment provided in our center. As a consequence, the risks of this trial do not exceed the risks of any routine PCI procedure at Medisch Spectrum Twente, because the PCIs in this study will not deviate in any way from the local clinical routine.

To investigate whether the clinical outcome is similar after the implantation of the Endeavor Resolute stent versus the XIENCE V stent (non-inferiority test).

Baseline, 1 month, 3 months, 1 year, 2 year

Intervention will involve randomization of the type of DES ( Endeavor Resolute vs XIENCE V) used in study population. Duration of randomization will be two years.