Clinical trial NCT01066650: The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente
Official title: The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Angina Pectoris
Unstable Angina Pectoris
Coronary Stenosis
Coronary Restenosis
Keywords: TWENTE
randomized study
stent
coronary stent
drug-eluting stent
Zotarolimus
Everolimus
Xience V
Endeavor Resolute
head to head comparison
real world patients
target vessel failure
investigator initiated study
coronary artery disease
coronary arteries
atherosclerosis
non inferiority
Lead sponsor: Foundation of Cardiovascular Research and Education Enschede
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 1391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: comparing target-vessel failure (TVF) of both stents
timeFrame: 1 year
Secondary outcomes:
measure: the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents
timeFrame: 1 year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twnete
state: Overijssel
Study officials:
affiliation: Thorax Centrum Twente
name: C. von Birgelen, MD,PhD,Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Stoel MG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials. Atherosclerosis. 2022 Aug;355:52-59. doi: 10.1016/j.atherosclerosis.2022.05.002. Epub 2022 May 20.
citation: von Birgelen C, van der Heijden LC, Basalus MW, Kok MM, Sen H, Louwerenburg HW, van Houwelingen KG, Stoel MG, de Man FH, Linssen GC, Tandjung K, Doggen CJ, van der Palen J, Lowik MM. Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2017 Mar 1;2(3):268-276. doi: 10.1001/jamacardio.2016.5190.
citation: van Houwelingen KG, Sen H, Lam MK, Tandjung K, Lowik MM, de Man FH, Louwerenburg JH, Stoel MG, Hartmann M, Linssen GC, Doggen CJ, von Birgelen C. Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):E76-82. doi: 10.1002/ccd.25713. Epub 2014 Nov 1.
citation: Sen H, Lam MK, Tandjung K, Lowik MM, Stoel MG, de Man FH, Louwerenburg JH, van Houwelingen GK, Linssen GC, Doggen CJ, Basalus MW, von Birgelen C. Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting Xience V stents in the randomized TWENTE trial: comparison of 2-year clinical outcome. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):74-81. doi: 10.1002/ccd.25464. Epub 2014 Mar 14.
citation: Tandjung K, Sen H, Lam MK, Basalus MWZ, Louwerenburg JHW, Stoel MG, van Houwelingen KG, de Man FHAF, Linssen GCM, Said SAM, Nienhuis MB, Lowik MM, Verhorst PMJ, van der Palen J, von Birgelen C. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial. J Am Coll Cardiol. 2013 Jun 18;61(24):2406-2416. doi: 10.1016/j.jacc.2013.04.005. Epub 2013 Apr 16.
citation: Tandjung K, Basalus MW, Sen H, Stoel MG, van Houwelingen KG, Louwerenburg JH, de Man FH, Linssen GC, Said SA, Kleijne MA, van der Palen J, von Birgelen C. Women treated with second-generation zotarolimus-eluting resolute stents and everolimus-eluting xience V stents: insights from the gender-stratified, randomized, controlled TWENTE trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):396-405. doi: 10.1002/ccd.24848. Epub 2013 Mar 8.
citation: Sen H, Tandjung K, Basalus MW, Lowik MM, van Houwelingen GK, Stoel MG, Louwerenburg HW, de Man FH, Linssen GC, Nijhuis R, Nienhuis MB, Verhorst PM, van der Palen J, von Birgelen C. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents. EuroIntervention. 2012 Oct;8(6):664-71. doi: 10.4244/EIJV8I6A104.
citation: von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Said SA, Kleijne MA, Sen H, Lowik MM, van der Palen J, Verhorst PM, de Man FH. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol. 2012 Apr 10;59(15):1350-61. doi: 10.1016/j.jacc.2012.01.008. Epub 2012 Feb 15.