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OBJECTIVES: To establish a scoring system combining the ACEF score and the quantitative blood flow ratio (QFR) to improve the long-term risk prediction of patients undergoing percutaneous coronary intervention (PCI). METHODS: In this population-based cohort study, a total of 46 features, including patient clinical and coronary lesion characteristics, were assessed for analysis through machine learning models. The ACEF-QFR scoring system was developed using 1263 consecutive cases of CAD patients after PCI in PANDA III trial database. The newly developed score was then validated on the other remaining 542 patients in the cohort. RESULTS: In both the Random Forest Model and the DeepSurv Model, age, renal function (creatinine), cardiac function (LVEF) and post-PCI coronary physiological index (QFR) were identified and confirmed to be significant predictive factors for 2-year adverse cardiac events. The ACEF-QFR score was constructed based on the developmental dataset and computed as age (years)/EF (%) + 1 (if creatinine ≥ 2.0 mg/dL) + 1 (if post-PCI QFR ≤ 0.92). The performance of the ACEF-QFR scoring system was preliminarily evaluated in the developmental dataset, and then further explored in the validation dataset. The ACEF-QFR score showed superior discrimination (C-statistic = 0.651; 95% CI: 0.611-0.691, P < 0.05 versus post-PCI physiological index and other commonly used risk scores) and excellent calibration (Hosmer-Lemeshow χ2 = 7.070; P = 0.529) for predicting 2-year patient-oriented composite endpoint (POCE). The good prognostic value of the ACEF-QFR score was further validated by multivariable Cox regression and Kaplan-Meier analysis (adjusted HR = 1.89; 95% CI: 1.18-3.04; log-rank P < 0.01) after stratified the patients into high-risk group and low-risk group. CONCLUSIONS: An improved scoring system combining clinical and coronary lesion-based functional variables (ACEF-QFR) was developed, and its ability for prognostic prediction in patients with PCI was further validated to be significantly better than the post-PCI physiological index and other commonly used risk scores.
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BACKGROUND: The risk of side-branch (SB) occlusion is pivotal for decision making of stenting strategies during unprotected left main (LM) bifurcation percutaneous coronary intervention (PCI). Accordingly, this study aimed to develop a scoring system for predicting SB occlusion during unprotected LM bifurcation PCI. METHODS: A total of 855 consecutive patients undergoing unprotected LM bifurcation PCI with provisional strategy at Fuwai Hospital from January 2014 to December 2016 were recruited. A prediction model was selected by means of all-subsets logistic regression, and a multivariable risk score (Left Main Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [LM V-RESOLVE]) was then established with incremental weights attributed to each component variable based on its estimate coefficients. SB occlusion was defined as any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or absence of flow in SB after main vessel (MV) stenting. RESULTS: SB occlusion occurred in 19 LM bifurcation lesions (2.22%). In multivariable model, 3 variables, including MV/SB diameter ratio, MV plaque ipsilateral to SB, and baseline diameter stenosis of SB, were independent predictors for SB occlusion (model C-statistic 0.829, 95% confidence interval [CI] 0.735-0.923, with good calibration). The risk score had a C-statistics of 0.830 (95% CI 0.738-0.923) with good calibration. Satisfactory discriminative ability of the risk score was also preserved in external validation (C-statistic 0.794, 95% CI 0.691-0.896). CONCLUSIONS: The LM bifurcation-specific novel scoring system, LM V-RESOLVE, based on 3 simple baseline angiographic findings, could help to rapidly discriminate lesions at risk of SB occlusion during LM bifurcation PCI.
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Background The PRAISE (Prediction of Adverse Events Following an Acute Coronary Syndrome) score is a machine-learning-based model for predicting 1-year all-cause death, myocardial infarction, and Bleeding Academic Research Consortium (BARC) type 3/5 bleeding. Its utility in an unselected Asian population undergoing percutaneous coronary intervention for acute coronary syndrome remains unknown. We aimed to validate the PRAISE score in a real-world Asian population. Methods and Results A total of 6412 consecutive patients undergoing percutaneous coronary intervention for acute coronary syndrome were prospectively included. The PRAISE scores were compared with established scoring systems (GRACE [Global Registry of Acute Coronary Events] 2.0, PRECISE-DAPT (Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy), and PARIS [Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients]) to evaluate their discrimination, calibration, and reclassification. The risk of all-cause mortality (hazard ratio [HR], 12.24 [95% CI, 5.32-28.15]) and recurrent acute myocardial infarction (HR, 3.92 [95% CI, 1.76-8.73]) was greater in the high-risk group than in the low-risk group. The C-statistics for death, myocardial infarction, and major bleeding were 0.75 (0.67-0.83), 0.61 (0.52-0.69), and 0.62 (0.46-0.77), respectively. The observed to expected ratio of death, myocardial infarction, and major bleeding was 0.427, 0.260, and 0.106, respectively. Based on the decision curve analysis, the PRAISE score displayed a slightly greater net benefit for the 1-year risk of death (5%-10%) than the GRACE score did. Conclusions The PRAISE score showed limited potential for risk prediction in our validation cohort with acute coronary syndrome. As a result, new prediction models or model refitting are required with improved discrimination and accuracy in risk prediction.
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Acute Coronary Syndrome , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/surgery , Platelet Aggregation Inhibitors/adverse effects , Prognosis , Risk Assessment/methods , Treatment Outcome , Drug Therapy, Combination , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Myocardial Infarction/etiology , Ischemia/etiology , Percutaneous Coronary Intervention/adverse effectsABSTRACT
BACKGROUND: Prediabetes is common and associated with poor prognosis in patients with acute coronary syndrome and those undergoing revascularization. However, the impact of prediabetes on prognosis in patients with coronary intermediate lesions remains unclear. The objective of the current study is to explore the impact of prediabetes and compare the prognostic value of the different definitions of prediabetes in patients with coronary intermediate lesions. METHODS: A total of 1532 patients attending Fuwai hospital (Beijing, China), with intermediate angiographic coronary lesions, not undergoing revascularization, were followed-up from 2013 to 2021. Patients were classified as normal glucose tolerance (NGT), prediabetes and diabetes according to various definitions based on HbA1c or admission fasting plasma glucose (FPG). The primary endpoint was defined as major adverse cardiovascular events (MACE), the composite endpoint of all-cause death, non-fatal myocardial infarction and repeated revascularization therapy. Multivariate cox regression model was used to explore the association between categories of abnormal glucose category and MACE risk. RESULTS: The proportion of patients defined as prediabetes ranged from 3.92% to 47.06% depending on the definition used. A total of 197 MACE occurred during a median follow-up time of 6.1 years. Multivariate cox analysis showed that prediabetes according to the International Expert Committee (IEC) guideline (6.0 ≤ HbA1c < 6.5%) was associated with increased risk of MACE compared with NGT (hazard ratio [HR]: 1.705, 95% confidence interval [CI] 1.143-2.543) and after confounding adjustment (HR: 1.513, 95%CI 1.005-2.277). Consistently, the best cut-off point of glycated haemoglobin (HbA1c) identified based on the Youden's index was also 6%. Restricted cubic spline analysis delineated a linear positive relationship between baseline HbA1c and MACE risk. Globally, FPG or FPG-based definition of prediabetes was not associated with patients' outcome. CONCLUSIONS: In this cohort of patients with intermediate coronary lesions not undergoing revascularization therapy, prediabetes based on the IEC-HbA1c definition was associated with increased MACE risk compared with NGT, and may assist in identifying high-risk patients who can benefit from early lifestyle intervention.
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Blood Glucose , Prediabetic State , Humans , Glycated Hemoglobin , Prospective Studies , Risk Factors , FastingABSTRACT
Background: The Mediterranean-Dietary Approaches to Stop Hypertension for neurodegenerative delay (MIND) has been regarded as a novel healthy dietary pattern with huge benefits. However, its value in preventing and treating hypertension has not been investigated. The objective of this study is to investigate the impact of adhering to the MIND diet on the prevalence of hypertension in the entire population and long-term mortality in hypertensive patients. Methods: In this cross-sectional and longitudinal study, 6,887 participants consisting of 2,984 hypertensive patients in the National Health and Nutritional Examination Surveys were analyzed and divided into 3 groups according to the MIND diet scores (MDS; groups of MDS-low [<7.5], MDS-medium [7.5-8.0] and MDS-high [≥8.5]). In the longitudinal analysis, the primary outcome was all-cause death and the secondary outcome was cardiovascular (CV) death. Hypertensive patients received a follow-up with a mean time of 9.25 years (median time: 111.1 months, range 2 to 120 months). Multivariate logistics regression models and Cox proportional hazards models were applicated to estimate the association between MDS and outcomes. Restricted cubic spline (RCS) was used to estimate the dose-response relationship. Results: Compared with the MDS-low group, participants in the MDS-high group presented a significantly lower prevalence of hypertension (odds ratio [OR] 0.76, 95% confidence interval [CI] 0.58, 0.97, p = 0.040) and decreased levels of systolic blood pressure (ß = -0.41, p = 0.033). Among hypertensive patients, 787 (26.4%) all-cause death consisting of 293 (9.8%) CV deaths were recorded during a 10-year follow-up. Hypertensive patients in the MDS-high group presented a significantly lower prevalence of ASCVD (OR = 0.71, 95% CI, 0.51, 0.97, p = 0.043), and lower risk of all-cause death (hazard ratio [HR] = 0.69, 95% CI, 0.58, 0.81, p < 0.001) and CV death (HR = 0.62, 95% CI, 0.46, 0.85, p for trend = 0.001) when compared with those in the MDS-low group. Conclusion: For the first time, this study revealed the values of the MIND diet in the primary and secondary prevention of hypertension, suggesting the MIND diet as a novel anti-hypertensive dietary pattern.
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In order to achieve smart biomedical micro/nanomaterials, promote interaction with biomolecules, improve osteogenic/chondrogenic differentiation, exhibit better dispersion in bone implants and ultimately maximize functionality, we innovatively and successfully designed and synthesized polymer PBLG-modified GdPO4·H2O nanobunches by hydroxylation, silylation and glutamylation processes. The effects of different feeding ratios on the surface coating of GdPO4·H2O with Si-OH, the grafting γ-aminopropyltriethoxysilane (APS) and the in situ ring-opening polymerization reaction of poly(g-benzyl-L-glutamate) (PBLG) were investigated, and the physical and chemical properties were characterized in detail. When GdPO4·H2O@SiO2-APS:NCA = 4:1, the PBLG-g-GdPO4·H2O grafting rate was 5.93%, with good stability and dispersion in degradable polymeric materials. However, the MRI imaging signal was sequentially weakened as the modification process proceeded. Despite this, the biological effects had surprising findings. All the modifiers at appropriate concentrations were biocompatible and biologically active and the biomacromolecules of COL I and COL II in particular were expressed at least 3 times higher in GdPO4·H2O@SiO2 compared to the PLGA. This indicates that the appropriate surface modification and functionalization of gadolinium-containing micro/nanomaterials can promote interaction with cells and encourage bone regeneration by regulating biomacromolecules and can be used in the field of biomedical materials.
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Gadolinium , Osteogenesis , Gadolinium/pharmacology , Chondrogenesis , Phosphates/pharmacology , Silicon Dioxide/pharmacology , Cell Differentiation , Glutamic Acid/pharmacology , Polymers/chemistry , Tissue Scaffolds/chemistryABSTRACT
Background: The optimal treatment strategy for patients with coronary intermediate lesions, defined as diameter stenosis of 50-70%, remains a great challenge for cardiologists. Identification of potential biomarkers predictive of major adverse cardiovascular events (MACEs) risk may assist in risk stratification and clinical decision. Methods: A total of 1,187 patients with intermediate coronary lesions and available N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were enrolled in the current study. A baseline NT-proBNP level was obtained. The primary endpoint was defined as MACEs, the composite endpoint of all-cause death and non-fatal myocardial infarction. A multivariate Cox regression model was used to explore the association between NT-proBNP level and MACE risk. Results: The mean age of the study cohort was 59.2 years. A total of 68 patients experienced MACE during a median follow-up of 6.1 years. Restricted cubic spline analysis delineated a linear relationship between the baseline NT-proBNP level and MACE risk. Both univariate and multivariate analyses demonstrated that an increased NT-proBNP level was associated with an increased risk of MACE [adjusted hazard ratio (HR) per doubling: 1.412, 95% confidence interval (CI): 1.022-1.952, p = 0.0365]. This association remains consistent in clinical meaningful subgroups according to age, sex, body mass index (BMI), and diabetes. Conclusion: An increased NT-proBNP level is associated with an increased risk of MACE in patients with intermediate coronary lesions and may serve as the potential biomarker for risk stratification and treatment decision guidance.
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Acute Coronary Syndrome , Drug-Eluting Stents , Percutaneous Coronary Intervention , Acute Coronary Syndrome/drug therapy , Acute Coronary Syndrome/therapy , Drug Therapy, Combination , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Treatment OutcomeABSTRACT
Background: The objective of our study was to assess whether calculated low-density lipoprotein cholesterol (LDL-C) is inferior to direct LDL-C (dLDL-C) in identifying patients at higher risk of all-cause mortality, recurrent acute myocardial infarction (AMI), and major adverse cardiovascular event (MACE). Methods: A total of 9,751 patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) in the Fuwai PCI registry were included. DLDL-C was measured by the selective solubilization method (Kyowa Medex, Tokyo, Japan). Correct classification was defined as the proportion of estimated LDL-C in the same category as dLDL-C based on dLDL-C levels: less than 1.4, 1.4-1.8, 1.8-2.6, 2.6-3.0, and 3.0 mmol/L or greater. Results: Underestimation of LDL-C was found in 9.7% of patients using the Martin/Hopkins equation, compared with 13.9% using the Sampson equation and 24.6% with the Friedewald equation. Cox regression analysis showed compared the correct estimation group, underestimation of LDL-C by the Martin/Hopkins equation did not reduce all-cause mortality (HR 1.26, 95% CI: 0.72-2.20, P = 0.4), recurrent AMI (HR 1.24, 95% CI: 0.69-2.21, P = 0.5), and MACE (HR 1.02, 95% CI: 0.83-1.26, P = 0.9). Similarly, the overestimated group did not exacerbate all-cause mortality (HR 0.9, 95% CI: 0.45-1.77, P = 0.8), recurrent AMI (HR 0.63, 95% CI: 0.28-1.44, P = 0.3), and MACE (HR 1.07, 95% CI: 0.86-1.32, P = 0.6). The results of the diabetes subgroup analysis were similar to those of the whole population. Conclusion: Compared with dLDL-C measurement, misclassification by the Martin/Hopkins and Sampson equations was present in approximately 20% of patients. However, directly measured vs. calculated LDL-C did not identify any more individuals in the PCI population with increased risk of all-cause mortality, recurrent AMI, and MACE, even in high-risk patients such as those with diabetes.
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Background Lp(a) (lipoprotein[a]) plays an important role in predicting cardiovascular events in patients with coronary artery disease through its proatherogenic and prothrombotic effects. We hypothesized that prolonged dual antiplatelet therapy (DAPT) might be beneficial for patients undergoing percutaneous coronary intervention who had elevated Lp(a) levels. This study aimed to evaluate the effect of Lp(a) on the efficacy and safety of prolonged DAPT versus shortened DAPT in stable patients with coronary artery disease who were treated with a drug-eluting stent. Methods and Results We selected 3201 stable patients with CAD from the prospective Fuwai Percutaneous Coronary Intervention Registry, of which 2124 patients had Lp(a) ≤30 mg/dL, and 1077 patients had Lp(a) >30 mg/dL. Patients were divided into 4 groups according to Lp(a) levels and the duration of DAPT therapy (≤1 year versus >1 year). The primary end point was major adverse cardiovascular and cerebrovascular event, defined as a composite of all-cause death, myocardial infarction, or stroke. The median follow-up time was 2.5 years. Among patients with elevated Lp(a) levels, DAPT >1 year presented lower risk of major adverse cardiovascular and cerebrovascular event and definite/probable stent thrombosis compared with DAPT ≤1 year. In contrast, in patients with normal Lp(a) levels, the risks of major adverse cardiovascular and cerebrovascular event and definite/probable stent thrombosis were not significantly different between the DAPT >1 year and DAPT ≤1 year groups. Prolonged DAPT had 2.4-times higher risk of clinically relevant bleeding than shortened DAPT in patients with normal Lp(a) levels, although without statistical difference. Conclusions In stable patients with coronary artery disease, who underwent percutaneous coronary intervention with a drug-eluting stent, prolonged DAPT was associated with reduced risk of cardiovascular events among those with elevated Lp(a) levels, whereas it did not show statistically significant evidence of benefit for reducing ischemic events and tended to increase clinically relevant bleeding among those with normal Lp(a) levels.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Coronary Artery Disease/therapy , Drug Therapy, Combination , Humans , Lipoprotein(a) , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Coronary artery ectasia (CAE) is a rare finding in coronary angiography and associated with poor clinical outcomes. Unlike atherosclerosis, diabetes mellitus (DM) is not commonly associated with CAE. This study aims to investigate the effect of type 2 diabetes mellitus (DM2) on coronary artery ectasia, especially the differences in angiographic characteristics and clinical outcomes. METHODS: Patients with angiographically confirmed CAE from 2009 to 2015 were included. Quantitative coronary angiography (QCA) was performed to measure the diameter and length of the dilated lesion. The primary endpoint was the maximum diameter and maximum length of the dilated lesion at baseline coronary angiography. The secondary endpoint was 5-year major adverse cardiovascular events (MACE), which was a component of cardiovascular death and nonfatal myocardial infarction (MI). Propensity score weighting (PSW) and propensity score matching (PSM) were used to balance covariates. Kaplan-Meier method and Cox regression were performed to assess the clinical outcomes. RESULTS: A total of 1128 patients were included and 258 were combined with DM2. In the DM2 group, the maximum diameter of dilated lesion was significantly lower (5.26 mm vs. 5.47 mm, P = 0.004) and the maximum length of the dilated lesion was significantly shorter (25.20 mm vs. 31.34 mm, P = 0.002). This reduction in dilated lesion diameter (5.26 mm vs. 5.41 mm, P = 0.050 in PSW; 5.26 mm vs. 5.46 mm, P = 0.007 in PSM, respectively) and length (25.17 mm vs. 30.17 mm, P = 0.010 in PSW; 25.20 mm vs. 30.81 mm, P = 0.012 in PSM, respectively) was consistently observed in the propensity score analysis. A total of 27 cardiovascular deaths and 41 myocardial infarctions occurred at 5-year follow-up. Compared with non-DM group, there were similar risks of MACE (6.02% vs. 6.27%; HR 0.96, 95% CI 0.54-1.71, P = 0.894), cardiovascular death (2.05% vs. 2.61%; HR 0.78, 95% CI 0.29-2.05, P = 0.605) and MI (4.07% vs. 3.72%; HR 1.11, 95% CI 0.54-2.26, P = 0.782) in patients with DM2. Consistent result was observed in multivariable regression. CONCLUSIONS: Compared to non-DM patients, patients with CAE and type 2 diabetes were associated with a smaller diameter and shorter length of dilated vessels, suggesting the important effect of DM2 on the pathophysiological process of CAE. Similar risks of MACE were found during 5-year follow up among diabetic and non-DM patients.
Subject(s)
Computed Tomography Angiography , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Diabetes Mellitus, Type 2/complications , Aged , Coronary Artery Disease/complications , Diabetes Mellitus, Type 2/diagnosis , Dilatation, Pathologic , Disease Progression , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Risk Assessment , Risk Factors , Time FactorsABSTRACT
BACKGROUND: There is a paucity of real-world data regarding the clinical impact of dual antiplatelet therapy (DAPT) interruption (temporary or permanent) among patients at high ischemic risk. The aim of this study was to assess the risk of cardiovascular events after interruption of DAPT in high-risk PCI population. METHODS: This study used data from the Fuwai PCI registry, a large, prospective cohort of consecutive patients who underwent PCI. We assessed 3,931 patients with at least 1 high ischemic risk criteria of stent-related recurrent ischemic events proposed in the 2017 ESC guidelines for focused update on DAPT who were free of major cardiac events in the first 12 months. The primary ischemic endpoint was 30-month major adverse cardiac and cerebrovascular events, and the key safety endpoints were BARC class 2, 3, or 5 bleeding and net adverse clinical events. RESULTS: DAPT interruption within 12 months occurred in 1,122 patients (28.5%), most of which were due to bleeding events or patients' noncompliance to treatment. A multivariate Cox regression model, propensity score (PS) matching, and inverse probability of treatment weighting (IPTW) based on the propensity score demonstrated that DAPT interruption significantly increased the risk of primary ischemic endpoint compared with prolonged DAPT (3.9% vs. 2.2%; Cox-adjusted hazard ratio (HR): 1.840; 95% confidence interval (CI): 1.247 to 2.716; PS matching-HR: 2.049 [1.236-3.399]; IPTW-adjusted HR: 1.843 [1.250-2.717]). This difference was driven mainly by all-cause death (1.8% vs. 0.7%) and MI (1.3% vs. 0.5%). Furthermore, the rate of net adverse clinical events (4.9% vs. 3.2%; Cox-adjusted HR: 1.581 [1.128-2.216]; PS matching-HR: 1.639 [1.075-2.499]; IPTW-adjusted HR: 1.554 [1.110-2.177]) was also higher in patients with DAPT interruption (≤12 months), whereas no significant differences between groups were observed in terms of BARC 2, 3, or 5 bleeding. These findings were consistent across various stent-driven high-ischemic risk subsets with respect to the primary ischemic endpoints, with a greater magnitude of harm among patients with diffuse multivessel diabetic coronary artery disease. CONCLUSIONS: In patients undergoing high-risk PCI, interruption of DAPT in the first 12 months occurred infrequently and was associated with a significantly higher adjusted risk of major adverse cardiovascular events and net adverse clinical events. 2017 ESC stent-driven high ischemic risk criteria may help clinicians to discriminate patient selection in the use of long-term DAPT when the ischemic risk certainly overcomes the bleeding one.
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Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies , Stents/adverse effectsABSTRACT
OBJECTIVE: To assess the impact of intra-aortic balloon pumps (IABP) on patients with cardiogenic shock in an intensive care unit setting. BACKGROUND: IABP counterpulsation is a widely used mechanical circulatory support device, but its performance has been questioned. However, current evidence of IABP use in cardiogenic shock is very limited (mainly from the IABP-SHOCK II trial), which was restricted to cardiogenic shock complicating acute myocardial infarction. METHODS: This was a retrospective, real-world, cohort study based on the Medical Information Mart for Intensive Care III database. Adult patients with a diagnosis of cardiogenic shock were eligible. RESULTS: A total of 1028 patients with cardiogenic shock were assessed, including 384 patients who received IABP and 644 patients who did not. The in-hospital mortality was significantly lower in patients who received IABP (adjusted odds ratio: 0.75, 95% confidence interval: 0.62-0.91, p = 0.009). Analysis of secondary endpoints found that the use of IABP was associated with a significantly lower risk of 1-year mortality. After propensity score matching, the in-hospital mortality remained significantly lower in the IABP group (28.10% vs. 37.59%, p = 0.018). CONCLUSIONS: In the current cohort, IABP treatment was associated with a lower risk of in-hospital mortality in patients with cardiogenic shock. Due to the complexity of pathophysiology in cardiogenic shock and the discrepancies in current evidence, our results should be validated through further studies in the future.
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Intra-Aortic Balloon Pumping , Shock, Cardiogenic , Cohort Studies , Humans , Propensity Score , Retrospective Studies , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Treatment OutcomeABSTRACT
OBJECTIVES: To determine the association of extended-term (>12-month) versus short-term dual antiplatelet therapy (DAPT) with ischemic and hemorrhagic events in high-risk "TWILIGHT-like" patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) in clinical practice. BACKGROUND: Recent emphasis on shorter DAPT regimen after PCI irrespective of indication for PCI may fail to account for the substantial residual risk of recurrent atherothrombotic events in ACS patients. METHODS: All consecutive patients fulfilling the "TWILIGHT-like" criteria undergoing PCI were identified from the prospective Fuwai PCI Registry. High-risk patients (n = 8,358) were defined by at least one clinical and one angiographic feature based on TWILIGHT trial selection criteria. The primary ischemic endpoint was major adverse cardiac and cerebrovascular events at 30 months, composed of all-cause mortality, myocardial infarction, or stroke while BARC type 2, 3, or 5 bleeding was key secondary outcome. RESULTS: Of 4,875 high-risk ACS patients who remained event-free at 12 months after PCI, DAPT>12-month compared with shorter DAPT reduced the primary ischemic endpoint by 63% (1.5 vs. 3.8%; HRadj: 0.374, 95% CI: 0.256-0.548; HRmatched: 0.361, 95% CI: 0.221-0.590). The HR for cardiovascular death was 0.049 (0.007-0.362) and that for MI 0.45 (0.153-1.320) and definite/probable stent thrombosis 0.296 (0.080-1.095) in propensity-matched analyses. Rates of BARC type 2, 3, or 5 bleeding (0.9 vs. 1.3%; HRadj: 0.668 [0.379-1.178]; HRmatched: 0.721 [0.369-1.410]) did not differ significantly between two groups. CONCLUSIONS: Among high-risk ACS patients undergoing PCI, long-term DAPT, compared with shorter DAPT, reduced ischemic events without a concomitant increase in clinically meaning bleeding events, suggesting that prolonged DAPT can be considered in ACS patients who present with a particularly higher risk for thrombotic complications without excessive risk of bleeding.
Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Acute Coronary Syndrome/drug therapy , Acute Coronary Syndrome/therapy , Drug Therapy, Combination , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies , Treatment OutcomeABSTRACT
Background: Coronary artery ectasia (CAE) is found in about 1% of coronary angiography and is associated with poor clinical outcomes. The prognostic value of plasma big Endothelin-1 (ET-1) in CAE remains unknown. Methods: Patients with angiographically confirmed CAE from 2009 to 2015, who had big ET-1 data available were included. The primary outcome was 5-year major adverse cardiovascular events (MACE), defined as a component of cardiovascular death and non-fatal myocardial infarction (MI). Patients were divided into high or low big ET-1 groups using a cut-off value of 0.58 pmol/L, according to the receiver operating characteristic curve. Kaplan-Meier method, propensity score method, and Cox regression were used to assess the clinical outcomes in the 2 groups. Results: A total of 992 patients were included, with 260 in the high big ET-1 group and 732 in the low big ET-1 group. At 5-year follow-up, 57 MACEs were observed. Kaplan-Meier analysis and univariable Cox regression showed that patients with high big ET-1 levels were at increased risk of MACE (9.87 vs. 4.50%; HR 2.23, 95% CI 1.32-3.78, P = 0.003), cardiovascular death (4.01 vs. 1.69%; HR 2.37, 95% CI 1.02-5.48, P = 0.044), and non-fatal MI (6.09 vs. 2.84%; HR 2.17, 95% CI 1.11-4.24, P = 0.023). A higher risk of MACE in the high big ET-1 group was consistent in the propensity score matched cohort and propensity score weighted analysis. In multivariable analysis, a high plasma big ET-1 level was still an independent predictor of MACE (HR 1.82, 95% CI 1.02-3.25, P = 0.043). A combination of high plasma big ET-1 concentrate and diffuse dilation, when used to predict 5-year MACE risk, yielded a C-statistic of 0.67 (95% CI 0.59-0.74). Conclusion: Among patients with CAE, high plasma big ET-1 level was associated with increased risk of MACE, a finding that could improve risk stratification.
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Coronary artery ectasia (CAE) is a rare finding and is associated with poor clinical outcomes. However, prognostic factors are not well studied and no prognostication tool is available. In a derivation set comprising 729 consecutive CAE patients between January 2009 and June 2014, a nomogram was developed using Cox regression. Total of 399 patients from July 2014 to December 2015 formed the validation set. The primary outcome was 5-year major adverse cardiovascular events (MACE), a component of cardiovascular death and nonfatal myocardial infarction. Besides the clinical factors, we used quantitative coronary angiography (QCA) and defined QCA classification of four types, according to max diameter (< or ≥5 mm) and max length ratio (ratio of lesion length to vessel length, < or ≥1/3) of the dilated lesion. A total of 27 cardiovascular deaths and 41 nonfatal myocardial infarctions occurred at 5-year follow-up. The nomogram effectively predicted 5-year MACE risk using predictors including age, prior PCI, high sensitivity C-reactive protein, N-terminal pro-brain natriuretic peptide, and QCA classification (area under curve [AUC] 0.75, 95% CI 0.68-0.82 in the derivation set; AUC 0.71, 95% CI 0.56-0.86 in the validation set). Patients were classified as high-risk if prognostic scores were ≥155 and the Kaplan-Meier curves were well separated (log-rank p < 0.001 in both sets). Calibration curve and Hosmer-Lemeshow test indicated similarity between predicted and actual 5-year MACE survival (p = 0.90 in the derivation and p = 0.47 in the validation set). This study developed and validated a simple-to-use method for assessing 5-year MACE risk in patients with CAE.
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BACKGROUND: In China, ischemic heart disease is the main cause of mortality. Having cardiac rehabilitation and a secondary prevention program in place is a class IA recommendation for individuals with coronary artery disease. WeChat-based interventions seem to be feasible and efficient for the follow-up and management of chronic diseases. OBJECTIVE: This study aims to evaluate the effectiveness of a tertiary A-level hospital, WeChat-based telemedicine intervention in comparison with conventional community hospital follow-up on medication adherence and risk factor control in individuals with stable coronary artery disease. METHODS: In this multicenter prospective study, 1424 patients with stable coronary artery disease in Beijing, China, were consecutively enrolled between September 2018 and September 2019 from the Fuwai Hospital and 4 community hospitals. At 1-, 3-, 6-, and 12-month follow-up, participants received healthy lifestyle recommendations and medication advice. Subsequently, the control group attended an offline outpatient clinic at 4 separate community hospitals. The intervention group had follow-up visits through WeChat-based telemedicine management. The main end point was medication adherence, which was defined as participant compliance in taking all 4 cardioprotective medications that would improve the patient's outcome (therapies included antiplatelet therapy, ß-blockers, statins, and angiotensin-converting-enzyme inhibitors or angiotensin-receptor blockers). Multivariable generalized estimating equations were used to compare the primary and secondary outcomes between the 2 groups and to calculate the relative risk (RR) at 12 months. Propensity score matching and inverse probability of treatment weighting were performed as sensitivity analyses, and propensity scores were calculated using a multivariable logistic regression model. RESULTS: At 1 year, 88% (565/642) of patients in the intervention group and 91.8% (518/564) of patients in the control group had successful follow-up data. We matched 257 pairs of patients between the intervention and control groups. There was no obvious advantage in medication adherence with the 4 cardioprotective drugs in the intervention group (172/565, 30.4%, vs 142/518, 27.4%; RR 0.99, 95% CI 0.97-1.02; P=.65). The intervention measures improved smoking cessation (44/565, 7.8%, vs 118/518, 22.8%; RR 0.48, 95% CI 0.44-0.53; P<.001) and alcohol restriction (33/565, 5.8%, vs 91/518, 17.6%; RR 0.47, 95% CI 0.42-0.54; P<.001). CONCLUSIONS: The tertiary A-level hospital, WeChat-based intervention did not improve adherence to the 4 cardioprotective medications compared with the traditional method. Tertiary A-level hospital, WeChat-based interventions have a positive effect on improving lifestyle, such as quitting drinking and smoking, in patients with stable coronary artery disease and can be tried as a supplement to community hospital follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT04795505; https://clinicaltrials.gov/ct2/show/NCT04795505.
Subject(s)
Coronary Artery Disease , Coronary Artery Disease/drug therapy , Hospitals , Humans , Medication Adherence , Prospective Studies , Risk FactorsABSTRACT
The efficacy and safety of prolonged (>1-year) dual antiplatelet therapy (DAPT) duration in high-risk patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain unknown. All patients undergoing PCI at Fuwai hospital between January 2013 and December 2013 were prospectively enrolled into the Fuwai PCI registry. A total of 3,696 high-risk diabetics patients with at least one additional atherothrombotic risk factor were screened for inclusion. The primary efficacy outcome was the composite of all-cause mortality, myocardial infarction, or stroke. The median follow-up duration was 887 days. 69.8% of DM patients were on DAPT at 1 year without discontinuation. Based on multivariate Cox regression model and inverse probability of treatment weighting (IPTW) analysis, long-term (>1-year) DAPT reduced the risk of primary efficacy outcome (1.7% vs 4.1%; adjusted hazard ratio [adjHR]: 0.382, 95% confidence interval [CI]: 0.252 to 0.577; IPTW-HR: 0.362 [0.241 to 0.542]), as well as cardiovascular death and definite/probable stent thrombosis, compared with short-course (≤1-year) DAPT. Risk of the safety end point of clinically relevant bleeding (adjHR: 0.920 [0.467 to 1.816]; IPTW-HR: 0.969 [0.486 to 1.932]) was comparable between longer DAPT and shorter DAPT. A lower number of net clinical benefit adverse outcomes was observed with >1-year DAPT versus ≤1-year DAPT (adjHR: 0.471 [0.331 to 0.671]; IPTW-HR: 0.462 [0.327 to 0.652]), which appeared increasingly favorable in those with multiple atherothrombotic risk characteristics. In high-risk patients with DM receiving PCI who were event free at 1 year, DAPT prolongation resulted in significant reduction in the risk of ischemic events not offset by increase of clinically meaningful bleeding events, thereby achieving a net clinical benefit. Extending DAPT beyond the period mandated by guidelines seems reasonable in high-risk DM patients not deemed at high bleeding risk.
Subject(s)
Coronary Artery Disease/surgery , Diabetes Complications , Diabetes Mellitus , Duration of Therapy , Mortality , Myocardial Infarction/epidemiology , Platelet Aggregation Inhibitors/therapeutic use , Stroke/epidemiology , Aged , Aspirin/therapeutic use , Clopidogrel/therapeutic use , Coronary Artery Disease/complications , Dual Anti-Platelet Therapy/methods , Female , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Male , Middle Aged , Multivariate Analysis , Percutaneous Coronary Intervention , Postoperative Care , Proportional Hazards Models , Registries , Risk AssessmentABSTRACT
Background: Patients with diabetes mellitus (DM) are known to be at high-risk for both ischemic and bleeding complications post-percutaneous coronary intervention (PCI). The ischemic benefit vs. bleeding risk associated with extended dual antiplatelet therapy (DAPT) in high-risk "TWILIGHT-like" patients with diabetes mellitus after PCI has not been established. Methods: All consecutive high-risk patients fulfilling the "TWILIGHT-like" criteria undergoing PCI from January 2013 through December 2013 were identified from the prospective Fuwai PCI Registry. High-risk "TWILIGHT-like" patients were defined by at least one clinical and one angiographic feature based on the TWILIGHT trial selection criteria. The present analysis evaluated 3,425 diabetic patients with concomitant high-risk angiographic features who were event-free at 1 year after PCI. Median follow-up was 2.4 years. The primary effectiveness endpoint was a composite of death, myocardial infarction, or stroke (termed major adverse cardiac and cerebrovascular events), and primary safety endpoint was clinically relevant bleeding according to the Bleeding Academic Research Consortium types 2, 3, or 5. Results: On inverse probability of treatment weighting (IPTW) analysis, prolonged-term (>1-year) DAPT with aspirin and clopidogrel decreased the risk of primary effectiveness endpoint compared with shorter ( ≤ 1-year) DAPT [1.8 vs. 4.3%; hazard ratio (HR)IPTW: 0.381; 95% confidence interval (CI): 0.252-0.576; P < 0.001] and reduced cardiovascular death [0.1% vs. 1.8%; HRIPTW: 0.056 (0.016-0.193)]. Prolonged DAPT was also associated with a reduced risk of definite/probable stent thrombosis [0.2 vs. 0.7%; HRIPTW: 0.258 (0.083-0.802)] and non-significantly lower rate of myocardial infarction [0.5 vs. 0.8%; HRIPTW: 0.676 (0.275-1.661)]. There was no significant difference between groups in clinically relevant bleeding [1.1 vs. 1.1%; HRIPTW: 1.078 (0.519-2.241); P = 0.840). Similar results were observed in multivariable Cox proportional hazards regression model. Conclusion: Among high-risk PCI patients with diabetes mellitus without an adverse event through 1 year, extending DAPT >1-year significantly reduced the risk of major adverse cardiac and cerebrovascular events without an increase in clinically relevant bleeding, suggesting that such high-risk diabetic patients may be good candidates for long-term DAPT.
ABSTRACT
BACKGROUND: Coronary artery ectasia (CAE) is a rare finding in coronary angiography and associated with worse clinical outcomes. According to the extent of the dilated lesions, CAE is classified into diffuse and focal dilation. The difference in clinical outcomes between these 2 phenotypes remains unknown. METHODS: A cohort study was conducted comprising CAE patients identified by coronary angiography between January 2009 to December 2013. Follow-up was proceeded annually and the primary outcome was major adverse cardiovascular events (MACE) defined as a component of cardiovascular death and nonfatal myocardial infarction(MI). Kaplan-Meier method and Cox regression models were used to assess the clinical outcomes in diffuse CAE group and focal CAE group. Propensity score matching, propensity score weighting, and subgroup analysis were performed as sensitivity analysis. RESULTS: A total of 595 patients were included in this study, including 474 individuals with diffuse CAE and 121 with focal CAE. During a median follow-up of 87 months, Patients in diffuse CAE group showed significantly higher incidences of MACE (13.1% vs. 3.3%;HR 4.28, 95%CI 1.56-11.78, P = .005), as well as cardiovascular death (7.0% vs. 1.7%;HR 4.41, 95%CI 1.06-18.39, P = .041). Higher occurrence rate of MACE was consistent in propensity score matched cohort and propensity score weighted analysis. The same trend towards increased risk of MACE in diffuse CAE group was obtained among subgroup analysis. CONCLUSIONS: Patients with diffuse CAE was associated with increased risk of MACE compared to those with focal CAE. Diffuse dilation found in coronary angiography should receive more attention by physicians.