Background Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care. Methods The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly followup visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted. Discussion This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.
Background Vein graft failure is a crucial challenge in coronary artery bypass graft (CABG) surgery. Previous studies have suggested a patency benefit of the No-Touch vein harvesting technique, but only with small sample sizes. Materials and methods This study is a prospective, multicenter randomized clinical trial with a large sample size, aiming to investigate the efficacy of the No-Touch technique compared with the conventional approach. All patients requiring isolated CABG with left internal mammary artery plus at least one saphenous vein graft will be considered for entry into the study. Two thousand cases (1000 in each arm) will be enrolled over 1 to 2 years in 7 hospitals in China. Participants will be randomized in equal proportions between two surgical strategies: the No-Touch or conventional technique. The primary endpoint is graft vessel occlusion at 3 months after CABG surgery by CT coronary angiography. Secondary outcomes are major adverse cardiac or cerebrovascular events at 3 and 12 months post-operation and graft vessel occlusion at 1 year. Discussion This study will define the role of the No-Touch vein harvesting technique in CABG surgery and provide strong evidence to answer whether this technique could reduce vein graft occlusion.
Background Performance of Pooled Cohort Equations (PCEs) for atherosclerotic cardiovascular disease (ASCVD) risks varied across populations. Whether the recently developed Prediction for ASCVD Risk in China (China-PAR) model could accurately predict cardiovascular risks in real practice remains unclear. Methods A population-based cohort study in rural Beijing in the "stroke belt" in North China was used to externally validate PCE and China-PAR models for 5-year ASCVD risk prediction. Expected 5-year prediction risk using China-PAR model was compared with PCE (white). The models were assessed for calibration, discrimination, and reclassification. Results Among 11,169 adults aged 40 to 79 years over a median 6.44 years of follow-up, 1,921 participants developed a first ASCVD event during total 70,951 person-years. China-PAR model fairly predicted ASCVD risk in men but overestimated by 29.4% risk in women (calibration X-2 = 81.4, P < .001). Underestimations were shown by PCE as 76.2% in men and 88.2% in women with poor calibration (both P < .001). However, discrimination was similar in both models: C-statistics in men were 0.685 (95% CI 0.660-0.710) for China-PAR and 0.675 (95% CI 0.649-0.701) for PCE; C-statistics in women were 0.711 (95% CI 0.694-0.728) for China-PAR and 0.714 (95% CI 0.697-0.731) for PCE. Moreover, China-PAR did not substantially improve accuracy of reclassification compared with PCE. Conclusions China-PAR outperformed PCE in 5-year ASCVD risk prediction in this rural Northern Chinese population at average population risk level, fairly predicted risk in men, but overestimated risk in women; however, China-PAR did not meaningfully improve the accuracy of discrimination and reclassification at individual risk level.
Background Lowering low-density lipoprotein cholesterol (LDL-C) by statins is a key strategy for secondary prevention of acute coronary syndrome (ACS). However, few studies have examined prehospital statin use and admission LDL-C levels in ACS patients with history of myocardial infarction (MI) or revascularization. This study aimed to assess use of prehospital statins and LDL-C levels at admission in ACS patients with history of MI or revascularization. Methods Improving Care for Cardiovascular Disease in China project was a nationwide registry, with 192 participating hospitals reporting details of clinical information of ACS patients from November 2014. By May 2018, 80,282 patients with ACS were included. LDL-C levels were obtained from the initial admission lipid testing. Results Of the 80,282 ACS patients, 6,523 with a history of MI or revascularization were enrolled. Among them, 50.8% were receiving lipid-lowering therapy before hospitalization (statin monotherapy in 98.4%, combination in 1.2%). A total of 30.1% of patients had LDL-C < 70 mg/dL at admission. In patients receiving prehospital statins, 36.1% had LDL-C < 70 mg/dL compared to 24.0% without prehospital statins (P < .001). At discharge, 91.8% of patients were treated with statin monotherapy, 90.7% at moderate doses irrespective of prehospital statin use and LDL-C levels at admission. Conclusions Among ACS patients with history of MI or revascularization, half were not being treated with statin therapy prior to admission, and most had not attained LDL-C < 70 mg/dL despite prehospital statin use. There is an important opportunity to provide intensive statin or combination lipid-lowering therapy to these very high risk patients.
Background This study aimed to examine hospital performance on evidence-based management strategies for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and variations across hospitals. Methods Improving Care for Cardiovascular Disease in China (CCC)-ACS project is an ongoing registry and quality improvement project, with 150 tertiary hospitals recruited across China. We examined hospital performance on nine management strategies (Class I Recommendations with A Level of Evidence) based on established guidelines. We also evaluated the proportion of patients receiving defect-free care, which was defined as the care that included all the required management strategies for which the patient was eligible. The hospital-level variations in the performance were examined. Results From 2014 to 2018, 28,170 NSTE-ACS patients were included. Overall, 16% of patients received defect-free care. Higher-performing metrics were statin at discharge (93%), cardiac troponin measurement (92%), dual antiplatelet therapy (DAPT) within 24 hours (90%), and DAPT at discharge (85%). These were followed by metrics of beta-blocker at discharge (69%), angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) at discharge (59%), and risk stratification (56%). Lower-performing metrics were smoking cessation counseling (35%) and percutaneous coronary intervention (PCI) within recommended times (33%). The proportion of patients receiving defect-free care substantially varied across hospitals, ranging from 0% to 58% (Median (interquartile range):12% (7%-21%)). There were large variations across hospitals in performance on risk stratification, smoking cessation counseling, PCI within recommended times, ACEI/ARB at discharge and beta-blocker at discharge. Conclusions About one in six NSTE-ACS patients received defect-free care, and the performance varied across hospitals.
Background The Fontan procedure is the final step of the 3-stage palliative procedure commonly performed in children with single ventricle physiology. Thrombosis remains an important complication in children after this procedure. To date, guideline recommendations for the type and duration of thromboprophylaxis after Fontan surgery are mainly based on extrapolation of knowledge gained from adults at risk for thrombosis in other clinical settings. Warfarin is being used off-label, and because of its multiple interactions with other drugs and food, a new alternative is highly desirable. Rivaroxaban, a direct Factor Xa inhibitor with a predictable pharmacokinetic profile, is a candidate to address this medical need. Study design The UNIVERSE study is a prospective, open-label, active-controlled, multicenter study in children 2 to 8 years of age who have single ventricle physiology and had the Fontan procedure within the 4 months preceding enrollment. This study consists of 2 parts. In Part A, rivaroxaban pharmacokinetics, pharmacodynamics, safety, and tolerability are assessed to validate the pediatric dosing selected. In Part B, safety and efficacy of rivaroxaban versus acetylsalicylic acid are evaluated for thromboprophylaxis in children post-Fontan procedure. Children in each part will receive study drug for 12 months. Part A has been completed with 12 children enrolled. Enrollment into Part B is currently ongoing. c Conclusions The UNIVERSE study aims to provide dosing, pharmacokinetics/pharmacodynamics, safety, and efficacy information on the use of rivaroxaban, an oral anticoagulant, versus acetylsalicylic acid, an antiplatelet agent, in children with single ventricle physiology after the Fontan procedure.
Background Few studies have investigated the use of invasive strategy for patients with non-ST-segment elevation myocardial infarction (NSTEMI) in China. We aimed to describe the contemporary pattern of management, medically and invasively, in patients with NSTEMI across China. Methods Using data of China Acute Myocardial Infarction Registry, we analyzed the baseline characteristics, in-hospital medication, index coronary angiography (CAG) and revascularization by stratification of gender, age, and risk assessment. Primary outcomes included in-hospital major adverse cardio-cerebral events (MACCE, a composite of all-cause death, myocardial (re)infarction, and stroke) and length of stay (LOS). Results A total of 10,266 NSTEMI patients were enrolled between January 2013 and November 2016. Dual antiplatelet therapy and statins were prescribed in 92.9% and 92.1% of overall patients respectively. CAG was performed in 45.6% of these patients, and 40.9% had an index revascularization. Female, older or higher risk patients were less likely to receive CAG or revascularization. The rates of CAG were 67.9% in the provincial-level, 46.2% in the prefectural, and 12.1% in the county level hospitals. Of those patients undergoing revascularization, 77.0% (1,156/1,501) very-high-risk patients received urgent revascularization and 16.2% (440/2,699) high-risk patients underwent early revascularization as recommended. The overall in-hospital MACCE was 6.7%, and the median LOS was 10 (6) days. Revascularization was associated with reduction for in hospital MACCE regardless of risk and age. Conclusion Invasive management was underused and profoundly deferred among patients with NSTEMI in China. The risk-treatment paradox, procedure deferral and medical resources distribution imbalance may represent opportunities for improvement.
Background The purpose of the study was to examine the association between the type of preceding oral anticoagulant use (warfarin or direct oral anticoagulants [DOACs]) and in-hospital mortality among patients admitted with gastrointestinal bleeding. Methods In this observational cohort study, all patients admitted with a first-time gastrointestinal bleeding from January 2011 to March 2017 while receiving any oral anticoagulant therapy prior to admission were identified using data from Danish nationwide registries. The risk of in-hospital mortality according to type of oral anticoagulation therapy was examined by multivariable logistic regression models. Results Among 5,774 patients admitted with gastrointestinal bleeding (median age, 78 years [25th-75th percentile, 7185 years]; 56.8% men), 2,038 (35.3%) were receiving DOACs and 3,736 (64.7%) were receiving warfarin prior to admission. The unadjusted in-hospital mortality rates were 7.5% for DOAC (7.2% for dabigatran, 6.4% for rivaroxaban, and 10.1% for apixaban) and 6.5% for warfarin. After adjustment for baseline demographic and clinical characteristics, there was no statistically significant difference in in-hospital mortality between prior use of any DOAC and warfarin (unadjusted odds ratio [OR] 1.18 [95% CI 0.95-1.45], adjusted OR 0.97 [95% CI 0.77-1.24]). Similar results were found for each individual DOAC as compared with warfarin (dabigatran: unadjusted OR 1.12 [95% CI 0.84-1.49], adjusted OR 0.96 [95% CI 0.711.30]); rivaroxaban: unadjusted OR 0.98 [95% CI 0.71-1.37], adjusted OR 0.84 [95% CI 0.59-1.21]; and apixaban: unadjusted OR 1.62 [95% CI 0.84-1.49], adjusted OR 1.22 [95% CI 0.83-1.79]). Conclusions Among patients admitted with gastrointestinal bleeding, there was no statistically significant difference in in-hospital mortality between prior use of DOAC and warfarin.
Background Comparing with conservative strategy, early invasive approach has been shown to be beneficial for initially stabilized patients with non-ST-elevation myocardial infarction (NSTEMI). However, concerns of increased risk of bleeding and other complications associated with early revascularization in patients aged >= 75 years persist. A routinely deferred invasive strategy aiming to facilitate revascularization after stabilizing the culprit lesion predominates across China. Aim The aim was to compare efficacy and safety of deferred invasive strategy versus guideline-recommended early invasive strategy in initially stabilized Chinese patients aged >= 75 years with NSTEMI. Methods Twenty qualified centers from 10 different provinces throughout mainland China will contribute to the study. Eligible patients will be central randomized to a routine deferred invasive approach or an early invasive approach (coronary angiography >72 hours or <24 hours of admission and appropriate revascularization). Patients meeting the inclusion criteria but not randomized for any reason will be registered. The primary end point of the present study is a composite of all-cause mortality, nonlethal (re) MI, ischemic stroke, and urgent revascularization at 1 year. Noninferiority design is used, and the inferiority margin was set to be 5%. The goal is to enroll 696 patients with expected primary end point rates of 30%, 2-tailed a of .05, power of 80%, and dropout rate of 5%. Conclusions The DEAR-OLD trial is a prospective, nationwide, multicenter, noninferiority-designed, open-label randomized clinical trial evaluating efficacy and safety of routinely deferred invasive strategy compared with early invasive strategy in Chinese elderly patients with NSTEMI.
Background This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs). Methods This is a prospective, multicenter, open-label, randomized study comparing the use of drug-eluting balloon (DEB) versus second-generation everolimus-eluting stent for the treatment of DES ISR. The primary end point was in-segment late loss at 9-month routine angiographic follow-up. Results A total of 172 patients were enrolled, and 74 (43.0%) patients underwent the angiographic follow-up. The primary end point was not different between the 2 treatment groups (DEB group 0.15 +/- 0.49 mm vs DES group 0.19 +/- 0.41 mm, P=.54). The secondary end points of in-segment minimal luminal diameter (MLD) (1.80 +/- 0.69 mm vs 2.09 +/- 0.46 mm, P=.03), in-stent MLD (1.90 +/- 0.71 mm vs 2.29 +/- 0.48 mm, P=.005), in-segment percent diameter stenosis (34% +/- 21% vs 26% +/- 15%, P=.05), and in-stent percent diameter stenosis (33% +/- 21% vs 21% +/- 15%, P=.002) were more favorable in the DES group. The composite of death, myocardial infarction, or target lesion revascularization at 1 year was comparable between the 2 groups (DEB group 7.0% vs DES group 4.7%, P=.51). Conclusions Treatment of DES ISR using DEB or second-generation DES did not differ in terms of late loss at 9-month angiographic follow-up, whereas DES showed better angiographic results regarding minimal MLD and percent diameter stenosis. Both treatment strategies were safe and effective up to 1 year after the procedure.
Background: Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis. Trial design: Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR) trial is an international, multicenter, prospective, randomized clinical trial. A total of 1,700 consecutive patients with intermediate stenosis (40%-70% by visual estimation) in a major epicardial coronary artery will be randomized 1:1 to receive either FFR-guided or IVUS-guided PCI strategy. Patients will be treated with PCI according to the predefined criteria for revascularization; FFR <= 0.80 in the FFR-guided group and Minimal Lumen Area (MLA) <= 3 mm(2) (or <= 3 mm(2) < MLA <= 4 mm(2) and plaque burden >70%) in the IVUS-guided group. The primary end point is the patient-oriented composite outcome, which is a composite of all-cause death, myocardial infarction, and any repeat revascularization at 24 months after randomization. We will test noninferiority of current standard FFR-guided PCI strategy compared with IVUS-guided decision for PCI and stent optimization strategy. Conclusion: The FLAVOUR trial will compare the safety and efficacy of FFR- and IVUS-guided PCI strategies in patients with intermediate coronary stenosis. This study will provide an insight on optimal evaluation and treatment strategy for patients with intermediate coronary stenosis. (C) 2017 Elsevier Inc. All rights reserved.
Depression and acute coronary syndromes (ACS) are both common public health challenges. Patients with ACS often develop depression, which in turn adversely affects prognosis. Low-cost, sustainable, and effective service models that integrate depression care into the management of ACS patients to reduce depression and improve ACS outcomes are critically needed. Integrating Depression Care in ACS patients in Low Resource Hospitals in China (I-CARE) is a multicenter, randomized controlled trial to evaluate the efficacy of an 11-month integrated care (IC) intervention compared to usual care (UC) in management of ACS patients. Four thousand inpatients will be recruited and then randomized in a 1:1 ratio to an IC intervention consisting of nurse-led risk factor management, group-based counseling supplemented by individual problem-solving therapy, and antidepressant medications as needed, or to UC. The primary outcomes are depression symptoms measured by the Patient Health Questionnaire-9 at 6 and 12 months. Secondary endpoints include anxiety measured by the Generalized Anxiety Disorder-7; quality of life measured by the EQ-5D at 6 and 12 months; and major adverse events including the combined end point of all-cause death, suicide attempts, nonfatal myocardial infarction, nonfatal stroke, and all-cause rehospitalization at yearly intervals for a median follow-up of 2 years. Analyses of the cost-effectiveness and cost-utility of IC also will be performed. I-CARE trial will be the largest study to test the effectiveness of an integrated care model on depression and cardiovascular outcomes among ACS patients in resource-limited clinical settings. (C) 2018 Elsevier Inc. All rights reserved.