Recently, a team from Shanghai Tenth People’s Hospital of Tongji University published results of a clinical study in a top SCI journal-- Prognostic value of coronary microvascular dysfunction assessed by coronary angiography-derived index of microcirculatory resistance in diabetic patients with chronic coronary syndrome. The study pioneered the use of RainMed’s caIMR system to evaluate the coronary microcirculation in diabetic patients with chronic coronary syndrome (CCS), demonstrating that caIMR system can assess the impact of coronary microcirculation dysfunction (CMD) on those patients and independently predict the incidence rate of major adverse cardiac events (MACE) in them. This study suggests potential prognostic stratification indicators for clinical diabetes mellitus (DM) management, enables the prevention of coronary disease to the control stage of high-risk pathogenic factors, and expands the clinical application scenario of RainMed’s caIMR system, enhancing the market growth of caIMR system.

This paper was published in the world-renowned journal Cardiovascular Diabetology (IF 8.9). Clinical evidence demonstrated that CMD is a common finding among DM patients and may represent a potential determinant of adverse clinical outcomes. Timely recognition of CMD in DM patients is crucial in preventing adverse outcomes and improving their quality of life. Results revealed that IMR value measured by angiography-derived caIMR system can accurately predict the prognostic quality of diabetic patients with chronic coronary syndrome, which has an important role in improving the management level of diabetic patients with chronic coronary syndrome.

Two hundred and ninety patients were finally included in the analysis of this study. Among these, 102 (35.2%) patients had DM. During the study, surgeons used RainMed’s caIMR system to measure coronary index of microcirculatory resistance of enrolled patients, with caIMR=25 as the cut-off value. If caIMR≥25, it indicated coronary microvascular dysfunction and those were followed up for an average of 35 months. The results showed that:

1. Coronary microcirculation dysfunction is common in diabetic patients with chronic coronary syndrome, and compared with patients without coronary microcirculation dysfunction, those with coronary microcirculation dysfunction have a significantly higher incidence rate of MACE. Data shows that patients with caIMR≥25 had a higher rate of MACE than patients with caIMR<25 (20.6% vs. 8.2%, p=0.002). Of these, the MACE rate was higher among DM patients with caIMR≥25 than those with caIMR<25 (33.9% vs. 14.0%; p=0.022).

Physiological parameters of target vessels in the study population

2. Diabetic patients with chronic coronary syndrome are more likely to suffer from adverse cardiovascular events, and caIMR≥25 can be used as an independent predictor of MACE risk among diabetic patients with CCS. The data showed that among diabetic patients, whose caIMR≥25 had a significantly higher rate of MACE than those with caIMR < 25 (33.9% vs 14.0%; p=0.022); In non-diabetic patients, there was no significant difference in the incidence rate of MACE between caIMR≥25 and caIMR < 25 (9.7% vs. 6.0%; P = 0.349).

(A) Kaplan-Meier survival curves of MACE in DM patients with CCS according to caIMR; (B) Kaplan-Meier survival curves of MACE in non-DM patients with CCS according to caIMR. DM, diabetes mellitus; caIMR, coronary angiography-derived index of microcirculatory resistance

Diabetes mellitus is a common independent risk factor for the development of cardiovascular disease and is associated with increased risk of cardiovascular disease incidence and mortality. Previous studies have demonstrated that RainMed’s caIMR system can accurately predict the risk of MACE in patients with ST-elevated myocardial infarction (STEMI), non–ST-segment elevation myocardial infarction (NSTEMI), stable CAD and myocardial infarction with non-obstructive coronary arteries (MINOCA). This study pioneered the use of non-interventional IMR measurement products to verify the impact of coronary microcirculation dysfunction on diabetic patients with chronic coronary syndrome, providing a more simple and convenient diagnostic way for the clinical management of diabetes patients.

caIMR is a non-interventional microcirculation measurement product developed by RainMed Medical. It has completed world's first confirmatory clinical study of innovative IMR product with an accuracy of 93.81%, which means that caIMR system can replace traditional guidewire-derived IMR for large-scale clinical application. With the continuous advancement of clinical research, RainMed’s caIMR system is continuously unlocking new clinical application scenarios, broadening product application matrix, providing new management tool for more complex lesions and high-risk pathogenic factors, and promoting the development of vascular disease prevention and treatment.

caFFR system and caIMR system are the core products of the digital functional module of the robot system. In the future, these two products will act as the "eyes" of the robot system and be integrated into FlashBot. FlashBot organically integrates functional diagnostic system, imaging surgical navigation, ECG monitoring and other software, as well as hardware such as interventional multifunctional catheter and high-pressure injection, forming multi-system function integration and data closed-loop, realizing the whole process of automatic angiography, diagnosis, navigation and postoperative evaluation. At present, FlashBot coronary artery interventional surgery robot has been developed and successfully entered the animal experiment stage.