Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study ...aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).
This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.
MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively ( P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% 52/340 vs . 22.6% 85/376, P = 0.017). Risk of MACEs (hazard ratio HR = 0.69, 95% confidence interval CI: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR = 0.35, 95%CI: 0.13-0.95).
As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.
ChiCTR.org.cn, ChiCTR-TRC-12003513.
Percutaneous coronary interventions (PCI) of bifurcation lesions is technically challenging and associated with lower success rates and higher frequency of adverse outcomes. In the present study, we ...aimed to evaluate the immediate and long-term treatment effect and adverse events of a new modified jailed-balloon technique on side branch (SB) during PCI on coronary bifurcation lesions.
This was a prospective study of 60 patients (49 males, 11 females, mean age 66 ± 10 years) with coronary bifurcation lesions treated at the Beijing Hospital between September 2014 and October 2015. They underwent main vessel (MV) stenting and modified jailed-balloon technique on the SB. All patients were followed with hospital visits at 9 months. Angiographic success, major adverse cardiac events (MACE), SB occlusion, and angina were evaluated.
The majority of the patients had acute coronary syndrome (91.7%) and Medina 1.1.1. bifurcation lesions (71.7%). After MV stenting, thrombolysis in myocardial infarction (TIMI) 3 flow was established 100% of MV and 93.3% of SB. No SB occlusion occurred. The jailed SB balloon and wire could be successfully removed in all patients without damage or entrapment. The majority (91.7%) of patients achieved Canadian Cardiovascular Society I stage. There was no MACE during in-hospital stay and 9-month follow-up.
The modified JBT provided high rate of procedural success, excellent SB protection during MV stenting, and excellent immediate and long-term clinical outcomes.
Interstitial fluid (ISF) flow through vascular adventitia has been discovered recently. However, its kinetic pattern was unclear. We used histological and topographical identification to observe ISF ...flow along venous vessels in rabbits. By magnetic resonance imaging (MRI) in live subjects, the inherent pathways of ISF flow from the ankle dermis through the legs, abdomen, and thorax were enhanced by paramagnetic contrast. By fluorescence stereomicroscopy and layer-by-layer dissection after the rabbits were sacrificed, the perivascular and adventitial connective tissues (PACTs) along the saphenous veins and inferior vena cava were found to be stained by sodium fluorescein from the ankle dermis, which coincided with the findings by MRI. The direction of ISF transport in a venous PACT pathway was the same as that of venous blood flow. By confocal microscopy and histological analysis, the stained PACT pathways were verified to be the fibrous connective tissues, consisting of longitudinally assembled fibers. Real-time observations by fluorescence stereomicroscopy revealed at least two types of spaces for ISF flow: one along adventitial fibers and another one between the vascular adventitia and its covering fascia. Using nanoparticles and surfactants, a PACT pathway was found to be accessible by a nanoparticle of <100 nm and contained two parts: a transport channel and an absorptive part. The calculated velocity of continuous ISF flow along fibers of the PACT pathway was 3.6–15.6 mm/s. These data revealed that a PACT pathway was a “slit-shaped” porous biomaterial, comprising a longitudinal transport channel and an absorptive part for imbibition. The use of surfactants suggested that interfacial tension might play an essential role in layers of continuous ISF flow along vascular vessels. A hypothetical “gel pump” is proposed based on interfacial tension and interactions to regulate ISF flow. These experimental findings may inspire future studies to explore the physiological and pathophysiological functions of vascular ISF or interfacial fluid flow among interstitial connective tissues throughout the body.
The purpose of this study was to investigate the relationship between serum immunoglobulin M (IgM) and the severity of coronary artery disease in Chinese patients who underwent coronary angiography.
...A total of 2,045 patients who underwent coronary angiography (CAG) from March 2017 to March 2020 at Beijing Hospital were included in this study. Serum IgM concentration and biochemical indicators were measured before coronary angiography (CAG). The triquartile IgM levels at baseline in the population were analysed. Spearman rank correlation was used to analyse the association between IgM and traditional risk factors for coronary artery disease (CAD). CAD patients were divided into subgroups by affected area, number of affected vessels, and Gensini score to analyse the relationship between IgM and CAD severity. Multivariable logistic regression analysis was used to evaluate the association between IgM and CAD severity.
Serum IgM levels were significantly lower in the CAD group (63.5 mg/dL) than in the non-coronary artery disease (NCAD) group (72.3 mg/dL) (
< 0.001). Serum IgM levels were significantly associated with sex. Serum IgM levels were positively correlated with traditional CAD risk factors such as TG, TC and LDL-C (
< 0.05), and negatively associated with the number of obstructed vessels, the number of affected areas, and Gensini scores. After adjusting for age, sex, smoking status, hypertension, dyslipidaemia, diabetes, stroke, and statin use history, a high IgM level was independently negatively associated with the severity of CAD expressed by the Gensini score.
We determined that serum IgM was independently negatively associated with the severity of CAD diagnosed by angiography in Chinese adults.
To determine the prognostic value of cumulative calcification score of coronary artery calcification (CAC), thoracic aortic calcification (TAC) and aortic valve calcification (AVC) in acute ST ...segment elevation myocardial infarction (STEMI) patients.
This was a retrospective, single-center cohort study. A total of 332 STEMI patients who received primary percutaneous coronary intervention (PPCI) were enrolled in this study between January 2010 to October 2018. We assessed the calcification in the left anterior descending branch (LAD), left circumflex branch (LCX), right coronary artery (RCA), thoracic aorta, and aortic valve. Calcification of each part was counted as 1 point, and the cumulative calcification score was calculated as the sum of all points. The primary endpoint was all-cause mortality. Multivariate Cox proportional hazards models were used to determine association of cumulative calcification score with end points. The performance of the score was evaluated by receiver operating characteristic (ROC) curve analysis and absolute net reclassification improvement (NRI), compared with the Global Registry of Acute Coronary Events (GRACE) risk score.
The overall population's calcification score was 2.0 ± 1.6. During a mean follow-up time of 69.8 ± 29.3 months, the all-cause mortality rate was 12.1%. Kaplan-Meier curve showed that the score was significantly associated with mortality (log-rank p < 0.001). The multivariable Cox proportional hazard analyses showed that a calcification score of 4-5 was independently associated with all-cause death in STEMI patients hazard ratio (HR) = 2.32, 95% confidence interval (CI): 1.01-5.31, p = 0.046. The area under the ROC curve (AUC) of the calcification score was 0.67 (95% CI: 0.61-0.72), and the AUC of the GRACE score was 0.80 (95% CI: 0.75-0.84). There was no statistical difference in the predictive value between both scores for 3-year mortality in STEMI patients after PPCI (p = 0.06). Based on the NRI analysis, the calcification score showed better risk classification compared with the GRACE score (absolute NRI = 6.63%, P = 0.027).
The cumulative calcification score is independently associated with the long-term prognosis of STEMI patients after PPCI.
Background
Postprandial hyperglycemia plays an important role in the pathogenesis of coronary artery disease (CAD). The aim of this study is to determine the associations of 1,5-Anhydroglucitol ...(1,5-AG), which reflects circulating glucose fluctuations, with the prevalence of CAD and CAD severity in coronary angiography defined Chinese patients.
Methods
2970 Chinese patients undergoing coronary angiography were enrolled. Baseline demographics and medical history data was recorded. Serum 1,5-AG levels and biochemical parameters were measured. Baseline characteristics were compared across 1,5-AG categories in diabetes (DM) and non-DM groups. Logistic regression analysis was performed to evaluate the associations of 1,5-AG with the prevalence and severity of CAD.
Results
Lower 1,5-AG was significantly associated with higher Gensini scores in both DM and non-DM groups. Logistic regression analysis demonstrated that the associations of low 1,5-AG with the prevalence of CAD, elevated Gensini score and severe CAD robustly dose-response increased from undiagnosed DM with 1,5-AG ≥ 14µg/mL to DM with 1,5-AG < 14µg/mL even after adjusting for fasting blood glucose (FBG) or Hemoglobin A1c (HbA
1c
). The associations were more significant in persons with DM. Significant modification effect of DM on the relationship of 1,5-AG with elevated Gensini score was found. In addition, nonlinear relationship and threshold effects of 1,5-AG with CAD and severity were observed.
Conclusion
Low 1,5-AG is significantly and independently associated with CAD and CAD severity in Chinese patients undergoing coronary angiography. Measurement of 1,5-AG is useful to differentiate subjects with extensive glucose fluctuations and high CAD risks, especially in DM patients.
Clinical Trial Registration
ClinicalTrials.gov
, identifier NCT03072797.
Background: Diabetes mellitus is a major risk element for cardiovascular disease. In the present study we investigated whether 1,5-anhydroglucitol (1,5-AG), a new marker for glucose monitoring, can ...predict patient outcome following acute myocardial infarction (AMI). Methods: A total of 270 AMI patients who underwent coronary angiography (CAG) at Beijing Hospital from March 2017 to 2020 were enrolled in this prospective cohort study. The serum 1,5-AG concentration and biochemical indicators were evaluated prior to CAG. Cox regression analysis was used to investigate the relationship between 1,5-AG levels and major adverse cardiovascular and cerebrovascular events (MACCEs), and with all-cause mortality. Results: During the median follow-up period of 44 months, 49 MACCEs occurred and 33 patients died. The 1,5-AG level was significantly lower in the MACCEs group than in the MACCEs-free group (p = 0.001). Kaplan-Meier analysis also revealed that low 1,5-AG levels were associated with MACCEs (p < 0.001) and with all-cause mortality (p = 0.001). Multivariate analysis showed that low 1,5-AG (≤8.8 μg/mL) was an independent predictor of MACCEs (hazard ratio (HR) 2.000, 95% confidence interval (CI): 1.047–3.821, p = 0.036). However, 1,5-AG was not a significant predictor for all-cause mortality in AMI patients (p > 0.05). Conclusions: Low 1,5-AG levels can predict MACCEs in AMI patients, but not all-cause mortality. Clinical Trial Registration: NCT03072797
The evaluation of pathobiome strains should be conducted at the strain level, involving the identification of the functional genes, while considering the impact of ecological niche and drug ...interactions. The safety, efficacy, and quality management of live biotherapeutic products (LBPs), especially pathobiome strains, have certain peculiarities. Promising development methods include the recombinant LBP and active metabolites.
Background
A previous phase IV trial revealed sex as a potential effect modifier of MUSKARDIA efficacy in stable coronary artery disease (CAD).
Objective
To assess the clinical effect of MUSKARDIA as ...a supplemental treatment to optimal medical therapy (OMT) in stable CAD cases.
Methods
This study was a subgroup analysis of a multicenter, randomized, double-blinded, placebo-controlled phase IV clinical study. Eligible individuals underwent randomization to the oral MUSKARDIA and placebo groups and were treated for 24 months. All participants received OMT according to existing guidelines. The primary composite outcome was the major adverse cardiovascular event (MACE), included cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. The secondary composite outcome encompassed all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina and/or heart failure, and undergoing coronary procedure/surgery during treatment. Safety signals, especially cardiovascular adverse events (AEs), were analyzed.
Results
The female subgroup included 776 participants (384 and 392 in the MUSKARDIA and placebo groups, respectively). The occurrence of the primary composite outcome was lower in the MUSKARDIA group compared with placebo-treated individuals (HR = 0.27, 95%CI: 0.09–0.83;
P
= 0.02), but the secondary composite outcome showed no significant difference (HR = 0.77, 95%CI: 0.47–1.25;
P
= 0.29). The MUSKARDIA group had reduced incidence of cardiovascular AEs compared with placebo-treated cases (2.9% vs. 5.6%).
Conclusion
As a supplemental treatment to OMT, 24-month administration of MUSKARDIA is effective and safe in female stable CAD cases.
Clinical trial registration
https://clinicaltrials.gov/
, identifier NCT01897805.
Ketone bodies, including β-hydroxybutyrate (BHB), acetoacetate (AA), and acetone, can substitute and alternate with glucose under conditions of fuel/food deficiency. Ketone-body metabolism is ...increased in a myriad of tissue-metabolism disorders. Perturbations in metabolism are major contributors to coronary artery disease (CAD). We investigated the association of BHB with CAD. A total of 2,970 people of Chinese Han ethnicity were enrolled. The Gensini score was calculated for all patients who had positive findings. The serum level of BHB and other laboratory parameters were measured. The association of serum levels of metabolites with traditionally risk factors and CAD severity was analyzed. The BHB was found to be associated with some traditional risk factors of CAD and CAD severity, as determined by the Gensini score or the number of diseased regions. Moreover, BHB was associated with the T3/T1 tertiles of the Gensini score after the adjustment for traditional risk factors by multivariable logistic regression analysis. The association of BHB with CAD severity was more obvious in women. Taken together, these data suggest that the circulating BHB level is independently associated with CAD severity, and that this association is more pronounced in women.
PDF
