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

Foundation of Cardiovascular Research and Education Enschede

Status and phase: Completed; Phase 4

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

Treatments: Device: Resolute Integrity (Zotarolimus-eluting stent); Device: Promus Element (Everolimus-eluting stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT01331707

NTR2413 (Registry Identifier)

DUTCH PEERS

Details and patient eligibility

About

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.

Enrollment: 1,811 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,811 participants in 2 patient groups

Promus Element

Active Comparator group

Treatment:

Device: Promus Element (Everolimus-eluting stent)

Resolute Integrity

Active Comparator group

Treatment:

Device: Resolute Integrity (Zotarolimus-eluting stent)