Runlin Gao

Prevalence, awareness, treatment, and control of hypertension in China: data from the China National Nutrition and Health Survey 2002.

Background— The present article aims to provide accurate estimates of the prevalence, awareness, treatment, and control of hypertension in adults in China. Methods and Results— Data were obtained from sphygmomanometer measurements and an administered questionnaire from 141 892 Chinese adults ≥18 years of age who participated in the 2002 China National Nutrition and Health Survey. In 2002, ≈153 million Chinese adults were hypertensive. The prevalence was higher among men than women (20% versus 17%; P<0.001) and was higher in successive age groups. Overall, the prevalence of hypertension was higher in urban compared with rural areas in men (23% versus 18%; P<0.01) and women (18% versus 16%; P<0.001). Of the 24% affected individuals who were aware of their condition, 78% were treated and 19% were adequately controlled. Despite evidence to suggest improved levels of treatment in individuals with hypertension over the past decade, compared with estimates from 1991, the ratio of controlled to treated hypertension has remained largely unchanged at 1:4. Conclusions— One in 6 Chinese adults is hypertensive, but only one quarter are aware of their condition. Despite increased rates of blood pressure–lowering treatment, few have their hypertension effectively controlled. National hypertension programs must focus on improving awareness in the wider community, as well as treatment and control, to prevent many tens of thousands of cardiovascular-related deaths.

Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial

BACKGROUND The everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are noninferior to current-generation drug-eluting stents has not been established. OBJECTIVES This study sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China. METHODS Eligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in a 1:1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for noninferiority with a margin of 0.15 mm. RESULTS A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device success (98.0% vs. 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES-treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 ± 0.38 mm for BVS versus 0.13 ± 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (pnoninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0%, respectively; p = 1.00). CONCLUSIONS In the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year. (A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT]; NCT01923740).

1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis

BACKGROUND Compared with metallic drug-eluting stents, bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention. Whether or not these devices are as safe and effective as drug-eluting stents within the first year after implantation is unknown. METHODS We did a patient-level, pooled meta-analysis of four randomised trials in which 3389 patients with stable coronary artery disease or a stabilised acute coronary syndrome were enrolled at 301 academic and medical centres in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n=2164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n=1225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularisation) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation). All analyses were by intention to treat. The four randomised trials included in our meta-analysis are all registered with ClinicalTrials.gov, numbers NCT01751906, NCT01844284, NCT01923740, and NCT01425281. FINDINGS The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89-1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91-1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02-2·07], p=0·04), due in part to non-significant increases in peri-procedural myocardial infarction and device thrombosis with BVS (RR 2·09 [0·92-4·75], p=0·08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischaemia-driven target lesion revascularisation, and all revascularisation did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomised trials with less than 1 year of follow-up were included. INTERPRETATION In this meta-analysis, BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES. FUNDING Abbott Vascular.

Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.

BACKGROUND We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. METHODS Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. FINDINGS PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. INTERPRETATION No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. FUNDING Medtronic, Inc.

Prospective observational study of acute coronary syndromes in China: practice patterns and outcomes

Objective: To describe the investigation and management of patients admitted to hospitals in China with suspected acute coronary syndromes (ACS) and to identify potential areas for improvement in practice. Design: A multicentre prospective survey of sociodemographic characteristics, medical history, clinical features, in-hospital investigations, treatment practices and major events among patients with suspected ACS. Setting: Large urban public hospitals. Patients: Consecutive patients admitted to in-patient facilities with a diagnosis of suspected acute myocardial infarction (MI) or unstable angina pectoris. Main outcome measures: Myocardial infarction/re-infarction, heart failure, death. Results: Between September 2004 and May 2005, data were collected prospectively from 2973 patients admitted to 51 hospitals in 18 provinces of China. An initial diagnosis of ST elevation MI, non-ST elevation MI and unstable angina was made in 43%, 11% and 46% of patients, respectively. Diagnosis was inconsistent with objective measures in up to 20% of cases. At both tertiary and non-tertiary centres, there was little evidence that clinical risk stratification was used to determine the intensity of investigation and management. The mortality rate during hospitalisation was 5% overall and similar in tertiary and non-tertiary centres, but reported in-hospital re-infarction rates (8%) and heart failure rates (16%) were substantially higher at non-tertiary centres. Conclusion: This study has identified a number of areas in the management of ACS patients, including diagnosis and risk stratification, which deviate from current guidelines. These findings will help inform the introduction of widely used quality improvement initiatives such as clinical pathways.

2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy

BACKGROUND Bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention after their complete bioresorption. Randomised trials have shown non-inferiority between BVS and metallic drug-eluting stents at 1 year in composite safety and effectiveness outcomes, although some increases in rates of target vessel-related myocardial infarction and device thrombosis were identified. Outcomes of BVS following the first year after implantation are unknown. We sought to ascertain whether BVS are as safe and effective as drug-eluting stents within 2 years after implantation and between 1 and 2 years. METHODS We did a systematic review and meta-analysis of randomised trials in which patients were randomly assigned to everolimus-eluting Absorb BVS or metallic everolimus-eluting stents (EES) and followed up for at least 2 years. We searched MEDLINE, the Cochrane database, TCTMD, ClinicalTrials.gov, Clinical Trial Results, CardioSource, and abstracts and presentations from major cardiovascular meetings up to April 1, 2017, to identify relevant studies. The primary efficacy outcome measure was the device-oriented composite endpoint (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation) and the primary safety outcome measure was definite or probable device thrombosis. Individual patient data from the four ABSORB trials were used for landmark and subgroup analysis and multivariable modelling. FINDINGS We identified seven randomised trials in which 5583 patients were randomly assigned to Absorb BVS (n=3261) or metallic EES (n=2322) and followed up for 2 years. BVS had higher 2-year relative risks of the device-oriented composite endpoint than did EES (9·4% [304 of 3217] vs 7·4% [169 of 2299]; relative risk [RR] 1·29 [95% CI 1·08-1·56], p=0·0059). These differences were driven by increased rates of target vessel-related myocardial infarction (5·8% [187 of 3218] vs 3·2% [74 of 2299]; RR 1·68 [95% CI 1·29-2·19], p=0·0003) and ischaemia-driven target lesion revascularisation (5·3% [169 of 3217] vs 3·9% [90 of 2300]; 1·40 [1·09-1·80], p=0·0090) with BVS, with non-significant differences in cardiac mortality. The cumulative 2-year incidence of device thrombosis was higher with BVS than with EES (2·3% [73 of 3187] vs 0·7% [16 of 2281]; RR 3·35 [95% CI 1·96-5·72], p<0·0001). Landmark analysis between 1 and 2 years also showed higher rates of the device-oriented composite endpoint (3·3% [69 of 2100] vs 1·9% [23 of 1193]; RR 1·64 [95% CI 1·03-2·61], p=0·0376) and device thrombosis (0·5% [11 of 2085] vs none [0 of 1183], p<0·0001) in BVS-treated patients than in EES-treated patients. INTERPRETATION BVS was associated with increased rates of composite device-oriented adverse events and device thrombosis cumulatively at 2 years and between 1 and 2 years of follow-up compared with EES. FUNDING Abbott Vascular.

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operators discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturers instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

Pretreatment with simvastatin reduces myocardial no‐reflow by opening mitochondrial KATP channel

Simvastatin, a cholesterol‐lowering agent, can protect against endothelial dysfunction. However, the effects of simvastatin treatment on the restoration of blood flow to ischemic myocardium are not known. This study sought to assess such effects of simvastatin on an experimental model of myocardial no‐reflow and to explore possible mechanisms.

Intracoronary delivery of autologous bone marrow mononuclear cells radiolabeled by 18F‐fluoro‐deoxy‐glucose: Tissue distribution and impact on post‐infarct swine hearts

Intracoronary injection of the bone marrow‐derived mononuclear cells (MNCs) is emerging as a potentially novel therapy for ischemic heart failure. This study was aimed at assessing the efficacy of intracoronary MNC delivery in the myocardium. The in vivo distribution and myocardial homing of intracoronarily delivered MNCs in experimental Chinese swine with acute myocardial infarction (AMI) created by occlusion of left anterior descending (LAD) coronary artery for 90 min. MNCs radiolabeled with 18F‐fluoro‐deoxy‐glucose (18F‐FDG) were delivered using a coronary catheter into the infarct‐related coronary artery 1 week after AMI. Dual‐nuclide single photon emission computed tomography (SPECT) revealed that 1 h after cell infusion, 6.8 ± 1.8% of 18F‐FDG‐labeled MNCs occurred in the infarcted myocardium with the remaining activity found primarily in the liver and spleen. In the heart, MNCs were detected predominantly in the under‐perfused myocardium. The infused cells retained in the hearts at a rate highly correlated with the under‐perfused lesional sizes. Pathological examination further demonstrated that 6 weeks after infusion, compared to controls, the hearts receiving MNCs exhibited less fibrosis and inflammatory infiltrate, more viable tissue, and higher vascular density. Cardiac function was significantly improved in the MNC‐infused hearts. Thus, 18F‐FDG labeling and dual‐nuclide SPECT imaging is capable of monitoring in vivo distribution and homing of MNCs after intracoronary infusion. MNC coronary delivery may improve cardiac function and positive ventricular remodeling in the heart with AMI. J. Cell. Biochem. 102: 64–74, 2007.

Different effects of tirofiban and aspirin plus clopidogrel on myocardial no-reflow in a mini-swine model of acute myocardial infarction and reperfusion

Objective: To compare the effects of an aspirin–clopidogrel combination with those of the specific glycoprotein IIb/IIIa inhibitor tirofiban on myocardial no-reflow, nitric oxide concentration and activity of nitric oxide synthase (NOS) isoforms in a mini-swine model of acute myocardial infarction and reperfusion. Methods: Area of no-reflow was determined by both myocardial contrast echocardiography and pathological means in 40 mini-swine randomly assigned to five study groups: eight controls, eight pretreated with aspirin–clopidogrel combination for three days, eight given an intravenous infusion of tirofiban, eight treated with ischaemic preconditioning and eight sham operated. The acute myocardial infarction and reperfusion model was created with 3 h occlusion of the left anterior descending coronary artery followed by 1 h reperfusion. Results: Compared with the control group, tirofiban significantly decreased the area of no-reflow assessed echocardiographically and pathologically, from 78.5% to 22.8% and 82.3% to 23.2%, respectively (both p < 0.01), and increased blood nitric oxide concentration (p < 0.05), enhanced constitutive NOS activity from 0.51 to 0.81 U/mg protein and mRNA expression from 0.47% to 0.66%, but decreased inducible NOS activity from 0.76 to 0.41 U/mg protein and mRNA expression from 0.54% to 0.39% in reflow myocardium (all p < 0.05–0.01). In contrast, the aspirin–clopidogrel combination did not significantly modify the above parameters (all p > 0.05) except for decreasing inducible NOS activity from 0.76 to 0.39 U/mg protein (p < 0.01) and mRNA expression from 0.54% to 0.40% (p < 0.05). Conclusions: Tirofiban is very effective in attenuating myocardial no-reflow; in contrast, aspirin–clopidogrel combination is totally ineffective. These findings also support the concept that endothelial protection, apart from platelet inhibition, contributes to the beneficial effect of tirofiban on myocardial no-reflow.