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

Keimyung University

Status: Unknown

Conditions: Coronary Artery Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Arteriosclerosis; Coronary Disease

Treatments: Device: Everolimus-Eluting stent; Device: Zotarolimus-Eluting stent

Study type: Observational

Funder types: Other

Identifiers

NCT02770651

2016-01-030

APPOSITION-AMI II (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 1 patient group

Optical Coherence Tomography

Description:

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.

Treatment:

Device: Zotarolimus-Eluting stent

Device: Everolimus-Eluting stent