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

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA); Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca); Device: Coronary stent implantation; Device: Bare Metal Coronary Stent

• Registration Number: NCT00704561
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-24
• Study First Posted: 2008-06-25
• Primary Completion: 2009-04
• Study Completion: 2009-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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])

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES - Zotarolimus Drug eluting stents	ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)	Zotarolimus Drug eluting stents in overlap
BMS -Bare metal stent	DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)	Bare metal stent
DES - Zotarolimus Drug eluting stents	Coronary stent implantation	Zotarolimus Drug eluting stents in overlap
BMS -Bare metal stent	Bare Metal Coronary Stent	Bare metal stent

Primary Outcome Measures

Name	Time	Method
Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent	6 months	Non inferiority

Secondary Outcome Measures

Name	Time	Method
number of well apposed stent struts without neointima	6 months	number of well apposed stent struts without neointima
number of malapposed stent struts without neointima	6 months	number of malapposed stent struts without neointima
number of sections with > 30% uncovered struts/total struts	6 months	number of sections with \> 30% uncovered struts/total struts
Number of sections with incomplete strut apposition	6 months	Number of sections with incomplete strut apposition
Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)	6 months	Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)
In segment OCT neontimal volume	6 months	In segment OCT neontimal volume

Trial Locations

Locations (1)

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy