Paradigm Shift in the Treatment of Patients With ACS

Conditions

Acute Coronary Syndrome

Brief summary

This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).

Seegers LM, Yeh DD, Wood MJ, Yonetsu T, Minami Y, Araki M, Nakajima A, Yuki H, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK.

2023-09-165 citations

10.1016/j.amjcard.2023.08.152

Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT.

Zeng M, Zhao C, Bao X, Liu M, He L, Xu Y, Meng W, Qin Y, Weng Z, Yi B, Zhang D, Wang S, Luo X, Lv Y, Chen X, Sun Q, Feng X, Gao Z, Sun Y, Demuyakor A, Li J, Hu S, Guagliumi G, Mintz GS, Jia H, Yu B.

2022-12-1432 citations

10.1016/j.jcmg.2022.10.023

High endothelial shear stress and stress gradient at plaque erosion persist up to 12 months.

Kim HO, Jiang B, Poon EKW, Thondapu V, Kim CJ, Kurihara O, Araki M, Nakajima A, Mamon C, Dijkstra J, Lee H, Ooi A, Barlis P, Jang IK.

2022-03-166 citations

10.1016/j.ijcard.2022.03.035

Age and Phenotype of Patients With Plaque Erosion

Makoto Araki, Taishi Yonetsu, Osamu Kurihara, Akihiro Nakajima, Hang Lee et al. (19 authors)

Journal of the American Heart Association2021-09-2514 citations

10.1161/jaha.120.020691

EROSION Study (Effective Anti-Thrombotic Therapy Without Stenting: Intravascular Optical Coherence Tomography–Based Management in Plaque Erosion)

Lei Xing, Erika Yamamoto, Tomoyo Sugiyama, Haibo Jia, Lijia Ma et al. (17 authors)

Circulation Cardiovascular Interventions2017-12-01167 citations

10.1161/circinterventions.117.005860

Interventions

DRUGTicagrelor

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

* Men or non-pregnant women \>18 years of age and \< 75 years of age * Patients undergo cardiac catheterization for ACS. Patients with STEMI, NSTEMI, and UAP will be included. STEMI will be defined as continuous chest pain for \>30 minutes, arrival at the hospital within 12 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). NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. UAP will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest. * Culprit lesion located in a native coronary artery * TIMI flow grade 3 and diameter stenosis \< 70% on angiogram * Definite erosion defined by OCT * Patients able to provide written informed consent

Exclusion criteria

Left ventricular ejection fraction \< 30%. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction of thrombus burden by OCT	30 days	The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.

Secondary

Measure	Time frame	Description
Cardiovascular adverse events	30 days and 12 months	In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events during1 month follow up (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding).

Countries

China

Outcome results

None listed