The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente

Foundation of Cardiovascular Research and Education Enschede1,391 enrolled

Overview

The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.

Primary research questions To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to compare for both drug-eluting stents the combined endpoint of death, myocardial infarction or revascularization related to the target-vessel, as well as death or myocardial infarction that cannot be related to a significant flow obstruction in another vessel or to another cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V® is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a controlled randomized trial yet.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,391

Conditions

Coronary Artery Disease Angina Pectoris

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Indication for PCI with DES implantation based on VVC/ESC guidelines and/or clinical decision of interventional cardiologist * Age ≥ 18 years and mentally capable to give an informed consent * Signed informed consent Exclusion Criteria: * Patients with ST-elevation myocardial infarction (STEMI) or an ST- elevation myocardial infarction equivalent requiring primary PCI or rescue PCI * Patients in whom the revascularization procedure is planned to be performed in a staged approach * Renal failure requiring haemodialysis * Patient is currently participating in an investigational drug or device study that has been not completed * In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study * Life expectancy less than 1 year * Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded. * If the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only.

Outcomes

Primary Outcomes

comparing target-vessel failure (TVF) of both stents

Time frame: 1 year

Secondary Outcomes

the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents