Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

• Conditions: Myocardial Ischemia; Cardiovascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis; Coronary Artery Disease; Coronary Disease; Heart Diseases; Vascular Diseases
• Interventions: Device: Everolimus-Eluting stent; Device: Zotarolimus-Eluting stent

• Registration Number: NCT02770651
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

Detailed Description

It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release. Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes. However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis. Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-01
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-25
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI
• Patient ≥ 18 years of age
• Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure
• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
• culprit lesion

Exclusion Criteria

• The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media
• Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment
• Cardiogenic shock
• Patient with left ventricular ejection fraction <30%
• Patient with left main disease
• Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted)
• Patient with impaired renal function (creatinine >2.0mg/dL)
• Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts
• bifucation lesion needs complex procedure with insert two or more Drug eluting stents.
• lesion length >30mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography	Zotarolimus-Eluting stent	To evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.
Optical Coherence Tomography	Everolimus-Eluting stent	To evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymerversus zotarolimus-eluting stent (ZES) with permanent polymer implantation in patients with AMI at 12 months.

Primary Outcome Measures

Name	Time	Method
Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups	12month	Incidence of malapposed and uncovered stent strut measured by OCT

Secondary Outcome Measures

Name	Time	Method
Mean neointima thickness	12month	By OCT, neointima thickness can be measured as distance from the endoluminal surface of the neointima to the stent strut.(mean neointima thickness in millimeter)
Percent neointima cross-sectional area	12month	By OCT, percentage neointima cross sectional area can be obtained by dividing the neointimal area by the stent area.(neointima cross-sectional area in mm²(Quadratmillimeter)/sec)
Morphologic characteristics of neointima	12month	Morphologic characteristics of neointima measured by OCT(morphologic characteristics of neointima is one of fibrous, fibrocalcific, lipid-laden)

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of