On November 4, 2021, Professor Yu Bo's team from the Second Affiliated Hospital of Harbin Medical University announced the results of the first prospective multicenter randomized controlled study of OST-up myocardial infarction (STEMI) reperfusion strategies comparing optical coherence tomography (OCT) guidance and contrast guidance at the world's largest conference on interventional cardiology: the American Congress of Transcatheter Cardiovascular Therapy (TCT) 2021, the world's latest clinical trial session, The findings are encouraging.
The study is based on the "13th Five-Year Plan" National Key Research and Development Program of the Ministry of Science and Technology "Construction of Myocardial Protection System and Key Technology Research on the Whole Process of Acute Myocardial Infarction", led by Yu Bo, President of the Second Affiliated Hospital of Harbin Medical University, and Professor Liu Bin of the Second Hospital of Jilin University as the sub-project leader, and jointly participated in the prospective multi-center randomized controlled clinical trial jointly participated by 9 centers across the country. The results of EROISON III showed that the use of OCT to guide the treatment of PATIENTS WITH STEM after early opening of the offender's blood vessels significantly reduced stent implantation rates without increasing MACE within 1 year. The OCT is safe and feasible to guide the formulation and optimization of individualized reperfusion therapy decisions in PATIENTS WITH STEMI.
According to Professor Yu Bo, the leader of the project, the current reperfusion strategy for STEMI patients is mainly conventional stent implantation treatment, which largely ignores the pathophysiology mechanism of STEMI, especially some patients with mild residual stenosis after the opening of blood vessels and stable blood flow may not need stent implantation; at the same time, some patients may have different degrees of stent-related near- and long-term complications (stent-related restention and intrastent thrombosis) after stent implantation. In severe cases, the patient's life can be threatened again.
The EROSION III study is the first multicenter randomized controlled study comparing the early post-opening and post-reperfusion strategies of STEMis patients with OCT guidance and contrast guidance, and for the first time confirms that the REperfusion strategy based on pathophysiology mechanism and lesion characteristics under OCT guidance can safely and effectively reduce the proportion of stent implantation in STEMI patients after early vascular opening; for patients who need stent implantation, OCT guidance can obtain better stent immediate results after stenting. Theoretically, the occurrence of stent-related complications is reduced.
This study is a successful practice of the concept of interventional residue-free precision reperfusion therapy based on lesion characteristics under the guidance of OCT. At the same time, due to the limitation of sample size, the safety endpoint of this study is not yet statistically effective, and larger prospective clinical studies are still needed to verify and optimize in the future to further improve the clinical prognosis of patients.
Professor Ziad A. Ali
Columbia University Medical Center, USA
Professor Ziad A. Ali of Columbia University Medical Center, an internationally renowned expert in cardiovascular interventional and endoluminal imaging
Highly praised the research team's proposed and continuously confirmed treatment concept of individualized non-stent implantation through the EROSION series of studies. Professor Ali pointed out that with the continuous development of basic research and clinical diagnosis and treatment technology, our understanding of the pathophysiology mechanism of STEMI occurrence and the understanding of the treatment strategy of STEMI patients are also changing.
We are moving from the previous "one-size-fits-all" conventional stent implantation strategy towards individualized treatment decisions based on advanced endovascular imaging techniques to assess the biological and specific characteristics of plaque in vitro.
This study once again prospectively confirmed in vitro that not all STEMIs are caused by plaque rupture, and plaque erosion is also an important cause, accounting for about one-third of all STEMI patients. At the same time, Professor Ali also pointed out that for such a new personalized non-stent treatment strategy, we are still in the process of continuous learning, and its long-term clinical prognosis and related social and economic benefits also need further in-depth research.
Professor Roxana Mehran
Mount Sinai Medical College, New York
Professor Roxana Mehran, an internationally renowned interventional cardiologist and clinical research expert at the Mount Sinai School of Medicine in New York and co-chair of the TCT Conference, fully affirmed the importance of endoluminal imaging in this non-stent treatment strategy, Professor Roxana Mehran said that for STEMI patients, if endoscopic imaging is not performed, even if a relatively stable coronary blood flow is obtained through thrombotic aspiration, Ending the procedure without intervention (stent implantation) can be worrying for interventional physicians.
However, if the overall features of the lesion are relatively stable after intraluminal imaging is performed after the return to stable blood flow, then non-stent-only drug therapy will make interventional physicians feel safer.
This is especially true for some younger women, as they are more likely to develop spontaneous coronary artery dissection (SCAD).
At the same time, the lower-grade thrombosis aspirate technique recommended in the current international guidelines has been fully discussed. Professor Jia Haibo pointed out that the high use rate of thrombosis in this study is mainly related to the large thrombotic load of the selected patients in this study, although the thrombotic suction technique is not currently a routine recommendation in PPCI surgery, but most experts believe that for patients with large thrombotic load and expected mild residual stenosis, thrombotic aspiration still has important application value. In this study, both thrombotic aspirate contrast and OCT examination found that high-quality thrombotic aspiration can significantly reduce the thrombotic load and residual lumen stenosis at the lesion site, thereby helping patients obtain relatively stable anterior coronary blood flow and a large residual lumen area, which is also an important basis for non-stent therapy.
Research protocol and interpretation of results
The OCT is currently the only end-of-cavity imaging tool that can identify the pathophysiology of patients with STEMI. The EROSION series of studies is mainly due to the discovery in early clinical practice that some PATIENTS WITH STEMI, especially those with OCT indicative of plaque erosion, after the necessary pretreatment to restore stable blood flow, the basal lumen is usually relatively large and the plaque is relatively stable, for these patients, at least in theory, it may only require dual antiplatelet therapy and avoid stents. Based on this hypothesis, the team conducted the first prospective proof-of-concept study, the EROSION study, which confirmed that non-stenting treatment was safe and effective in 70% of ACS patients with plaque erosion in residual stenosis <. The ATTEMPT III study aimed to compare the efficacy and safety of ALL STEMI reperfusion therapy strategies after early opening of the offender's blood vessels under OCT guidance and contrast guidance by randomization control.
In the EROSION III study, 246 patients enrolled (post-bleeding contrast showing residual diameter narrowing by necessary thrombosis to obtain stable blood flow ≤70%) were randomly placed in octotherapy and contrast coaching groups. Among them, a total of 226 patients could be included in the analysis of the protocol set, 112 cases in the OCT guidance group and 114 cases in the contrast guidance group. In the OCT group, non-stent-alone pharmacological therapy is recommended for patients with plaque erosion, spontaneous coronary artery dissection, or plaque rupture without dissection. (As shown in Figure 1)
Figure 1. Research flowcharts
The primary endpoint results showed that the stent implantation rate in the OCT guidance group was only 43.8%, compared with 58.8% in the contrast guidance group. OCT guidance can significantly reduce stent implant rates by 15%. (As shown in Figure 2)
Figure 2. Primary effective endpoint results
Across the OCT guidance group, 26% of patients were treated with plaque erosion, the vast majority of whom were treated conservatively with drugs alone, and 66% had plaque rupture, of which about 40% were treated with non-stents. (As shown in Figure 3)
Figure 3
The safety endpoint showed that there was no significant difference in the incidence of major cardiovascular and cerebrovascular events in the two groups between 30 days and 1 year after surgery
Expert Profiles
Professor Yu Bo
Level II Professor, Chief Physician, Doctoral Supervisor, FACC. He is currently the President of the Cardiovascular Hospital and director of the Department of Cardiology of the Second Hospital of Harbin Medical University, and the director of the Department of Internal Medicine of the Second Hospital of Harbin Medical University. Vice Chairman of the Cardiovascular Disease Branch of the Chinese Medical Association, Vice President of the Cardiovascular Physician Branch of the Chinese Medical Doctor Association, Chairman of the Grassroots Working Committee of the Cardiovascular Physician Branch of the Chinese Medical Doctor Association, Chairman of the Oncology And Cardiology Professional Committee of the Chinese Medical Doctor Association, Director of the Regional Certification Office of the China Chest Pain Center, Director of the Key Laboratory of Myocardial Ischemia of the Ministry of Education, and Chairman of the Heilongjiang Cardiovascular Society. He is the Associate Editor of the Critical Journal, Chinese Journal of Interventional Cardiology, JACC Cardiovascular Intervention (Chinese Edition) and an editorial board member of more than ten professional journals.
As the chief scientist, he led one of the "13th Five-Year Plan" National Major Chronic Disease Key Special Projects, and presided over 7 projects of the National Natural Science Foundation of China, including 1 major instrument research and development project and 2 key projects. He published 338 articles, of which 153 were included in SCI, with a cumulative impact factor of more than 650, of which the highest impact factor was 23.425 (EHJ). He is the chief editor of 2 monographs in the field, and leads and participates in the formulation of 10 guidelines and consensus in the industry. Won the second prize of the 2019 National Science and Technology Progress Award, the first prize of the Huaxia Medical Science and Technology Award, the first prize of the Chinese Medical Science and Technology Award, the 2021 He Liang He Li Foundation Science and Technology Award, the 8th Industry Highest Award "Chinese Physician Award", 7 provincial and ministerial awards, 6 invention patents, and 5 utility model patents.