DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population

Study Overview
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Brief Summary
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The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

Official Title
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DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)

Conditions
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Coronary Artery Disease, Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Stenosis, Coronary Restenosis

Intervention / Treatment
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* Device: Resolute Integrity (Zotarolimus-eluting stent)
* Device: Promus Element (Everolimus-eluting stent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years; Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement; Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent. Exclusion Criteria: Participation in another randomized drug or device study before reaching primary endpoint; Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined; Known pregnancy; Life expectancy of less than 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Promus Element<br> | Device: Promus Element (Everolimus-eluting stent)<br>* Third generation drug-eluting stent<br>|
| Active Comparator: Resolute Integrity<br> | Device: Resolute Integrity (Zotarolimus-eluting stent)<br>* Third generation drug-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zotarolimus, drug-eluting stent, Everolimus, all comers population, target vessel failure, coronary artery disease