Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography (NeoCover)

Harbin Medical University

Status

Terminated

Conditions

Acute Myocardial Infarction

Treatments

Device: Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)

Device: Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01875835

HMUOCT-STEMI

Details and patient eligibility

About

Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.

However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: 18-75 years
Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
Length of culprit lesion≤25mm.
Vessel size in between 2.5 and 4.0 mm.
Signed patient informed consent.

Exclusion criteria

Prior administration of thrombolytic therapy.
Cardiogenic shock.
Renal failure (Crea≥2.0mg/dL).
Recent major bleeding.
Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
Left main disease
Multi-vessel lesion
Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
No suitable anatomy for OCT scan.