Clinical trial NCT03062826: EROSION II: OCT Guided PPCI in STEMI
Official title: A Prospective, Multi-center, Optical Coherence Tomography Guided Reperfusion Strategy in Patients With STEMI (EROSION II)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: Optical Coherence Tomography
ST-segment Elevation Myocardial Infarction
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Shenzhen Salubris Pharmaceuticals Co., Ltd.
name: Beijing Luhe Hospital
name: The First Hospital of Jilin University
name: China-Japan Union Hospital, Jilin University
name: The First Affiliated Hospital of Dalian Medical University
name: Shanxi Cardiovascular Hospital
name: Second Hospital of Shanxi Medical University
name: Hebei General Hospital
name: General Hospital of Ningxia Medical University
name: Sichuan Provincial People's Hospital
name: Affiliated Hospital of Jiangsu University
name: Xiamen Cardiovascular Hospital, Xiamen University
name: Shenzhen Sun Yat-sen Cardiovascular Hospital
name: LanZhou University
name: Sir Run Run Shaw Hospital
name: Wuhan Asia Heart Hospital
First posted: 2017-02-23
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is STEMI patients who undergo primary cardiac catheterization.

Brief summary: This protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis \<70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI) with stent implantation. All the patients will be followed by intracoronary OCT and physiological assessment at 1-month and 12-month follow-up.

Detailed description: EROSION (Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion) study, a single-center, uncontrolled, prospective, proof-of concept study, showed that for patients with ACS caused by non-obstructive plaque erosion, conservative treatment with anti-thrombotic therapy without stenting may be an option. However, it is unknown whether plaque rupture with large lumen area and non-obstructive stenosis can be treated medically without stenting. EROSION II study is a prospective, multi-center, observational study to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis \<70% by visual assessment) can be stabilized and healed by effective antithrombotic treatment without stent implantation. Patients presenting with STEMI within 24 hours from the onset of ischemic symptoms will be included for screening. Thrombus aspiration will be performed in patients with large thrombus burden and TIMI flow grade less than 2 to restore blood flow. OCT will be performed after antegrade blood flow restored to assess the underlying mechanism of culprit lesion including plaque rupture, plaque erosion, calcified nodule, spontaneous coronary artery dissection, and other uncommon reasons. OCT imaging of non-culprit vessels will be performed if feasible. Patients caused by plaque erosion or plaque rupture with minimal lumen area \> 1.6mm2 or non-obstructive stenosis (diameter stenosis \<70% by visual assessment) will be treated medically only with dual anti-platelet therapy for 12 months after discharge.

Serial OCT examination will be performed at 1-month and 12-month follow-up to assess the healing of original culprit lesion. Physiological assessment (either wire-based FFR or angio-based FFR) will also be performed to assess the hemodynamic function of culprit lesion. The primary endpoint is the reduction of thrombus burden assessed by OCT at 1-month follow-up. Presence of recurrent ischemia symptoms or positive FFR value are the indications for target lesion revascularization. Patients will be followed by phone calls by study coordinators or clinical visit at 1 month, 3 months, 6 months, 9 months and 12 months. Major cardiovascular adverse events (MACE) will be collected in all patients throughout the whole follow-up period. MACE is a composite of cardiac death, recurrent myocardial infarction, stroke, target lesion revascularization, major bleeding and unstable angina-induced rehospitalization.

Patients who do not meet the criteria after OCT imaging will be enrolled in registry cohort.

Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites. Blood samples will be stored at -80°C for potential biomarker test and multi-omics analysis.

Eligibility criteria: Inclusion Criteria:

* Men or non-pregnant women \>18 years of age and \< 75 years of age.
* Patients undergo cardiac catheterization for STEMI. STEMI will be defined as continuous chest pain for \>30 minutes, arrival at the hospital within 24 hours from chest pain onset, ST-segment elevation \>0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB).
* Culprit lesion located in a native coronary artery.
* TIMI flow grade 3 and diameter stenosis \< 70% by visual assessment on angiogram or MLA \> 1.6mm2.
* Plaque erosion and rupture defined by OCT.
* Patients able to provide written informed consent.

Exclusion Criteria:

* Left ventricular ejection fraction \< 30%.
* Lesions in LM, ostial LAD or RCA (defined as within 3 mm of the aorto-ostium).
* Long lesions, tortuous lesions and angulated lesions.
* More than 2 vessels with severe lesions.
* Massive residual thrombus after the thrombus aspiration.
* With the history of cardiopulmonary resuscitation (CPR), acute pulmonary edema and cardiac shock on the attacks.
* Life expectancy \< 1 year.
* Contraindication to the contrast media.
* Creatinine level \> 2.0 mg/dL or end-stage kidney disease.
* Serious liver dysfunction.
* Patients with hemodynamic or electrical instability (including shock).
* Any contraindication against the use of ticagrelor.
* Investigator considers the patient is not suitable.

Primary outcomes:
measure: Reduction of thrombus burden assessed by OCT
timeFrame: 30 days
Secondary outcomes:
measure: Major cardiovascular adverse events
timeFrame: 1, 3, 6, 9, 12 months after PCI
measure: Major cardiovascular adverse events
timeFrame: 1 and 12 months after PCI
measure: Effective flow area increase
timeFrame: 1 and 12 months after PCI
measure: Fractional flow reserve
timeFrame: 1 and 12 months after PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital, Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Sun Yat-sen Cardiovascular Hospital
state: Guangzhou
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Shenyang
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo YU, MD, PhD
role: STUDY_CHAIR
References: