Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography (OCTAMI)

A.O. Ospedale Papa Giovanni XXIII

Status: Completed

Conditions: Acute Myocardial Infarction

Treatments: Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA); Device: Coronary stent implantation; Device: Bare Metal Coronary Stent; Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00704561

457/2008

Details and patient eligibility

About

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Full description

Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset
• Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy)
• Vessel size in between 2.5 and 3.75 mm
• Signed patient informed consent

Exclusion criteria

• Lesions in coronary artery bypass grafts
• Significant left main disease
• Killip class IV
• Reecent major bleeding (6 months)
• Renal failure with creatinine value > 2.5 mg/dl
• Allergy to aspirin and or clopidogrel/ticlopidine
• Patient in anticoagulant therapy
• IMA due to a stent thrombosis
• No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [≥ 3.75 mm in diameter])

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

DES - Zotarolimus Drug eluting stents

Active Comparator group

Description:

Zotarolimus Drug eluting stents in overlap

Treatment:

Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)

Device: Coronary stent implantation

BMS -Bare metal stent

Active Comparator group

Description:

Bare metal stent

Treatment:

Device: Bare Metal Coronary Stent

Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)