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

Primary Purpose

Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)

Xience V (Everolimus-eluting stent)

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medisch Spectrum Twnete

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endeavor Resolute

Xience V

Arm Description

Outcomes

Primary Outcome Measures

comparing target-vessel failure (TVF) of both stents

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01066650

First Posted

February 9, 2010

Last Updated

July 27, 2015

Sponsor

Foundation of Cardiovascular Research and Education Enschede

1. Study Identification

Unique Protocol Identification Number

NCT01066650

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Foundation of Cardiovascular Research and Education Enschede

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1391 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endeavor Resolute

Arm Type

Active Comparator

Arm Title

Xience V

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)

Other Intervention Name(s)

Endeavor Resolute stent

Intervention Description

Drug eluting Stent

Intervention Type

Device

Intervention Name(s)

Xience V (Everolimus-eluting stent)

Other Intervention Name(s)

Xience V drug eluting stent

Intervention Description

Drug eluting stent

Primary Outcome Measure Information:

Title

comparing target-vessel failure (TVF) of both stents

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

C. von Birgelen, MD,PhD,Prof

Organizational Affiliation

Thorax Centrum Twente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medisch Spectrum Twnete

City

Enschede

State/Province

Overijssel

ZIP/Postal Code

7513ER

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

35641327

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.

Results Reference

derived

PubMed Identifier

28114618

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.

Results Reference

derived

PubMed Identifier

25339110

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.

Results Reference

derived

PubMed Identifier

24585502

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.

Results Reference

derived

PubMed Identifier

23602769

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.

Results Reference

derived

PubMed Identifier

23359390

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.

Results Reference

derived

PubMed Identifier

22581199

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.

Results Reference

derived

PubMed Identifier

22341737

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.

Results Reference

derived

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

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