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

Conditions

Angina Pectoris, Coronary Artery Disease, Coronary Restenosis, Coronary Stenosis, Unstable Angina Pectoris

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

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.

van Vliet D, Pinxterhuis TH, Ploumen EH, Kok MM, Buiten RA, Zocca P, Roguin A, Schotborgh CE, Anthonio RL, Danse PW, Benit E, Aminian A, Doggen CJM, von Birgelen C.

2025-07-061 citations

10.1016/j.ijcha.2025.101741

Sex and age-specific 10-year mortality after coronary stenting: an analysis of two randomized trials

Tineke H. Pinxterhuis, Eline H. Ploumen, Carine J.M. Doggen, Daphne van Vliet, Marlies M. Kok et al. (12 authors)

European Heart Journal Open2024-12-24

10.1093/ehjopen/oeaf006

Ten-year mortality after treating obstructive coronary atherosclerosis with contemporary stents in patients with or without concomitant peripheral arterial disease.

Pinxterhuis TH, Ploumen EH, van Vliet D, Gert van Houwelingen K, Stoel MG, de Man FH, Hartmann M, Zocca P, Linssen GC, Geelkerken RH, Doggen CJ, von Birgelen C.

2024-03-263 citations

10.1016/j.atherosclerosis.2024.117488

Premature coronary artery disease in all-comers undergoing first PCI

Tineke H. Pinxterhuis, Eline H. Ploumen, Paolo Zocca, Carl E. Schotborgh, Rutger L. Anthonio et al. (10 authors)

European Heart Journal2023-11-01

10.1093/eurheartj/ehad655.1342

First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents

Tineke H. Pinxterhuis, Eline H. Ploumen, Carine J.M. Doggen, Marc Hartmann, Carl E. Schotborgh et al. (12 authors)

European Heart Journal Acute Cardiovascular Care2023-08-224 citations

10.1093/ehjacc/zuad098

Impact of premature coronary artery disease on adverse event risk following first percutaneous coronary intervention

Tineke H. Pinxterhuis, Eline H. Ploumen, Paolo Zocca, Carine J.M. Doggen, Carl E. Schotborgh et al. (13 authors)

Frontiers in Cardiovascular Medicine2023-06-195 citations

10.3389/fcvm.2023.1160201

Clinical outcome up to 2 years after percutaneous coronary intervention in all-comers with concomitant symptomatic peripheral arterial disease: a pooled analysis in 9,204 randomized trial participants

Tineke H. Pinxterhuis, Eline H. Ploumen, Paolo Zocca, Carine J.M. Doggen, Carl E. Schotborgh et al. (14 authors)

European Heart Journal2022-10-01

10.1093/eurheartj/ehac544.2044

Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS.

Hommels TM, Hermanides RS, Berta B, Fabris E, De Luca G, Ploumen EH, von Birgelen C, Kedhi E.

2020-10-021 citations

10.1186/s12933-020-01116-2

Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients

Clemens von Birgelen, Liefke C. van der Heijden, Mounir W.Z. Basalus, Marlies M. Kok, Hanim Sen et al. (14 authors)

JAMA Cardiology2017-01-2349 citations

10.1001/jamacardio.2016.5190

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.

Tandjung K, Sen H, Lam MK, Basalus MWZ, Louwerenburg JHW, Stoel MG, van Houwelingen KG, de Man FHAF, Linssen GCM, Saïd SAM, Nienhuis MB, Löwik MM, Verhorst PMJ, van der Palen J, von Birgelen C.

2013-04-1652 citations

10.1016/j.jacc.2013.04.005

A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial.

von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Saïd SA, Kleijne MA, Sen H, Löwik MM, van der Palen J, Verhorst PM, de Man FH.

2012-02-15179 citations

10.1016/j.jacc.2012.01.008

Interventions

DEVICEEndeavor Resolute (Biolinx-based Zotarolimus-eluting stent)

Drug eluting Stent

DEVICEXience V (Everolimus-eluting stent)

Drug eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
comparing target-vessel failure (TVF) of both stents	1 year

Secondary

Measure	Time frame
the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents	1 year

Countries

Netherlands

Outcome results

None listed