Objective: To develop a set of data elements and standardized definitions of Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration (CardiaCare), aiming to facilitate the exchange of disparate data sources, enhance the abilities to support multicenter researches, and subsequently ensure the databases use under standardized process and criteria. Methods: The Cardiacare writing committee members reviewed data elements and definitions from published guidelines, clinical trials, databases, and standardized documents, then determined the data elements and standardized definitions, which should be included in CardiaCare. The writing committee also considered the specific domestic clinical management strategies during the establishment of Cardiacare. The resulting documents provide a series of key data elements and standardized definitions used in the management of coronary artery disease patients. Key data elements from CardiaCare could be sorted by clinical management flowsheet and outcome from hospitalization to long-term follow-up. Results: The Cardiacare standardized set comprised 864 data elements from admission to post-hospital follow-up visit. There were 8 tables in the documents, including demographic and admission information (23 elements), medical history and risk factors (102 elements), clinical presentations and diagnosis (22 elements), diagnostic and laboratory tests (111 elements), interventional diagnosis and treatment (118 elements), pharmacological therapy (213 elements), clinical outcomes (161 elements), and special subpopulations (114 elements: 87 elements for transcatheter valve replacement and 27 elements with cardiac rehabilitation). Conclusions: The Cardiacare standardized data elements set could provide support for real-world clinical research in consecutive data collection and databases mining. A wider applicability in various settings of CardiaCare needs to be explored further.
Cardiac Rehabilitation ; Coronary Artery Disease/drug therapy* ; Fibrinolytic Agents ; Humans

BACKGROUNDIn patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG) in the patients with CTO and multivessel disease.

METHODSFrom a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n = 679) or DES (n = 267) treatment. Their propensity risk score was used for adjusting baseline differences.

RESULTSAt a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95%CI 1.219 - 3.179, P = 0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95%CI 5.739 - 45.391, P < 0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.

CONCLUSIONSOur study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.

Angioplasty, Balloon, Coronary ; methods ; Chronic Disease ; Coronary Angiography ; Coronary Artery Bypass ; methods ; Coronary Artery Disease ; surgery ; therapy ; Coronary Occlusion ; surgery ; therapy ; Drug-Eluting Stents ; Humans ; Prospective Studies

The effectiveness and safety of acupuncture combined with western medicine for angina of coronary artery disease are evaluated. Databases including Pubmed, Embase, Cochrane Library, CBMDisk,. CNKI, Wanfang, Chinese Clinical Trial Registry, etc. are searched with search time from beginning of the database establishment to January of 2014. As a result, totally 15 articles of acupuncture for angina of coronary artery disease that met the inclusive criteria were collected, involving 11 researches and 1 232 patients. The results of Meta-analysis indicate that based on regular western medicine, additional use of acupuncture could further improve symptoms of angina, increase efficacy of electrocardiogram (ECG) and reduce the dosage of nitroglycerin, in the meanwhile the hemorheology could be ameliorated, and the contents of C reactive protein (CRP), malondialdehyde (MDA), lipid peroxide (LPO), endothelin (ET) could be reduced, while the contents of superoxide dismutase (SOD) and nitric oxide (NO) could be increased; besides, the occurrence rate of cardiovascular event could be reduced without causing obvious adverse events. Except for certain outcomes (including dynamic ECG and blood viscosity) those have no statistical significance between treatment group and control group, the differences of remaining outcomes are: statistically significant. It is believed that acupuncture combined with regular treatment of western medicine are effective treatment plan for angina of coronary artery disease, which are superior to regular treatment of western medicine, but the results of this systematic review be taken with caution, and more clinical trials with high quality are looking forward to be included into Meta-analysis to increase the level of evidence.
Acupuncture Therapy ; Combined Modality Therapy ; Coronary Artery Disease ; drug therapy ; therapy ; Female ; Humans ; Treatment Outcome

Atrial Fibrillation ; complications ; drug therapy ; Coronary Artery Disease ; complications ; drug therapy ; Fibrinolytic Agents ; therapeutic use ; Humans

OBJECTIVETo compare the 2 years outcome of elderly patients with ULMCA stenosis undergoing coronary artery bypass grafting (CABG) or drug eluting stent (DES).

METHODSFrom January 2004 to June 2006, 295 patients with ULMCA stenosis and age > or = 70 years undergoing coronary revascularization with either CABG (n = 206) or DES (n = 89) were enrolled in this analysis. All-cause death, non-fatal myocardial infarction and target lesion revascularization (TLR) were recorded during 2 years follow-up.

RESULTSThe cumulative rate of 2-year mortality were 10.2% (n = 21) in CABG-treated patients and 13.3% (n = 12) in DES-treated patients (P = 0.428). The survival rate during 2-year follow-up was 89.2% for CABG-treated patients and 86.4% for DES-treated patients (P = 0.668). The incidence of 2-year myocardial infarction was 7.8% (n = 16) in CABG-treated patients and 10.1% (n = 9) in DES-treated patients (P = 0.501). The incidence of target lesion revascularization (TLR) was 4.9% (n = 10) in CABG-treated patients and 13.5% (n = 12) in DES-treated patients (P = 0.015). In the multivariable analysis, age (HR: 1.04, 95% CI: 1.01-1.09, P = 0.024), left ventricular dysfunction (ejection fraction < 30%, HR: 4.97, 95% CI: 1.22-24.85, P = 0.018) and type 2 diabetes (HR: 2.22, 95% CI: 1.31-4.86, P = 0.001) were independent predictors of 2-year mortality.

CONCLUSIONIn this study, 2-year mortality was comparable in elderly patients with ULMCA stenosis underwent CABG or DES. However, the rate of TLR was significantly higher in patients treated with DES than that receiving CABG operation.

Aged ; Aged, 80 and over ; Coronary Artery Bypass ; Coronary Artery Disease ; surgery ; therapy ; Drug-Eluting Stents ; Female ; Humans ; Male ; Treatment Outcome

BACKGROUNDDrug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes. However, the impact of biodegradable polymers on clinical events and stent thrombosis (ST) remains controversial.

METHODSWe searched Medline, the Cochrane Library and other internet sources, without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES. Safety endpoints were ST (definite, definite/probable), mortality, and myocardial infarction (MI). Efficacy endpoints were major adverse cardiac event (MACE) and target lesion revascularization (TLR).

RESULTSWe identified 15 randomized controlled trials (n = 17 068) with a weighted mean follow-up of 20.6 months. There was no statistical difference in the incidence of definite/probable ST between durable polymer- and biodegradable polymer- DES; relative risk (RR) 0.83; 95% confidence interval (CI) 0.62-1.11; P = 0.22. Biodegradable polymer DES had similar rates of definite ST (RR 0.94, 95% CI 0.66-1.33, P = 0.72), mortality (RR 0.94, 95% CI 0.82-1.09, P = 0.43), MI (RR 1.08, 95% CI 0.92-1.26. P = 0.35), MACE (RR 0.99, 95% CI 0.91-1.09, P = 0.85), and TLR (RR, 0.94, 95% CI 0.83-1.06, P = 0.30) compared with durable polymer DES. Based on the stratified analysis of the included trials, the treatment effect on definite ST was different at different follow-up times: ≤ 1 year favoring durable polymer DES and >1 year favoring biodegradable polymer DES.

CONCLUSIONSBiodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES. Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES.

Coronary Artery Disease ; drug therapy ; surgery ; Drug-Eluting Stents ; Humans ; Polymers ; administration & dosage ; Thrombosis

Background: Coronary calcification is a major determinant of stent underexpansion and subsequent adverse events. This study aimed to evaluate the acute- and long-term outcomes of rotational atherectomy (RA) followed by cutting balloon (CB) versus plain balloon before drug-eluting stent implantation for calcified coronary lesions. Methods: From June April 2013 to March 2016, a total of 127 patients with moderately or severely calcified coronary lesions were treated with RA. Patients were divided into two groups according to the balloon type after RA: RA+CB group (n = 75) and RA+plain balloon group (n = 52). Minimal lumen diameter and acute lumen gain were analyzed by quantitative coronary angiography. In-hospital and long-term (>1 year) outcomes were recorded. Multivariate Cox regression analysis was performed to determine the independent predictors of in-stent restenosis. Results: The mean age of the patients was 65.5 years, and 76.4% were men. Total lesion length and minimal lumen diameter at baseline were similar in the two groups. After RA and balloon dilation, the lumen diameter was significantly larger in the RA+CB group than in the RA+plain balloon group (1.57 ± 0.46 mm vs. 1.10 ± 0.40 mm, t = 4.123, P < 0.001). The final lumen diameter was also larger in the RA+CB group compared to that in the RA group (2.81 ± 0.41 mm vs. 2.60 ± 0.25 mm, t = 2.111, P = 0.039). Moreover, patients receiving RA and CB tended to have larger final lumen gain (2.15 ± 0.48 mm vs. 1.95 ± 0.47 mm, t = 1.542, P = 0.132). Multivariate Cox regression analysis indicated that the strategy of RA+CB was a significant protective factor against long-term (>1 year) in-stent restenosis (hazard ratio: 0.136, 95% confidence interval: 0.020-0.936, P = 0.043). Conclusions In patients with moderately or severely calcified lesions, a strategy of RA followed by CB before stent implantation can increase lumen diameter and acute lumen gain. This strategy is safe with lower risk of long-term in-stent restenosis.
Aged ; Angioplasty, Balloon, Coronary ; Atherectomy, Coronary ; Coronary Angiography ; Coronary Artery Disease ; diagnostic imaging ; therapy ; Drug-Eluting Stents ; Female ; Humans ; Male ; Percutaneous Coronary Intervention ; Stents ; Treatment Outcome

OBJECTIVETo evaluate the safety and efficacy of drug-eluting stent (DES) implantation in selective patients with left main coronary artery disease.

METHODFrom October 2002 to November 2007, 44 consecutive patients underwent percutaneous coronary interventions (PCI) on left main coronary artery lesions, including 5 patients with concurrent left ventricular dysfunction (ejection fraction<40%), 2 with chronic respiratory dysfunction and 5 with chronic renal failure. The findings in coronary angiography, procedural success rate, severe complications and the follow-up results of the patients were analyzed.

RESULTSThe immediate procedural success rate was 100% in these patients without any severe complications. No non-fatal acute myocardial infarction or emergency coronary artery bypass grafting (CABG) was performed and death occurred in none of the cases during hospitalization. In the follow-up period for 14.2-/+9.3 (6-65) months after PCI, no subacute or late thromboses were found. One patient died from heart failure 4 months after PCI, and 6 patients (13.6%) experienced recurrent angina. Thirty-seven patients (84.1%) were free of any major cardiovascular events (MACE) after the procedure. A repeat coronary angiography was performed in 35 patients (79.5%) within 6 months after PCI, and 3 (8.6%) of them were confirmed to have restenosis, including 1 patient with distal bifurcation restenosis who were subsequently treated with CABG and two patients with side-branch ostium restenosis managed with cutting balloon dilation.

CONCLUSIONSImplantation of drug-eluting stents is safe and effective for management of left main coronary artery disease with good immediate and long-term outcomes.

Adult ; Aged ; Angioplasty, Balloon, Coronary ; Coronary Angiography ; Coronary Artery Disease ; therapy ; Coronary Restenosis ; therapy ; Drug-Eluting Stents ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Treatment Outcome

OBJECTIVETo evaluate the efficacy and safety of Shenmai injection in the treatment of coronary heart disease (CHD).

METHODCNKI (1979 to December 2011), VIP (1989 to December 2011), and Wanfang Data (1987 to December 2011) were retrieved for literatures concerning randomized controlled trials of Shenmai injection in the treatment of coronary heart disease. Their quality was assessed by the Jadad scale. Review Manager 5.0 and Stata 12 software were adopted for data analysis.

RESULTAltogether 18 randomized clinical trials were included in the Meta-analysis. According to the findings, compared with routine therapy alone, the combination of Shenmai injection and routine therapy increased the overall effective rate by clinical symptoms by 22% [RD = 0.22, 95% CI (0.17, 0.26), P<0.000 01], with the relative risk ratio of [RR = 1.31, 95% CI (1.20, 1.43), P<0.000 1] and the efficacy by electrocardiogram by 25% [RD = 0.25, 95% CI (0.19, 0.31), P<0.000 01], with the relative risk ratio of [RR = 1.46, 95% CI (1.32, 1.62), P<0.000 1]. It also improved New York heart association classification (NYHA) by 33% [RD = 0.33, 95% CI (0.16, 0.49), P<0.000 01], with the relative risk ratio of [RR = 1.79, 95% CI (1.28, 2.51), P = 0.000 6] and left ventricular ejection fraction [WMD 7.55, 95% CI (2.28, 12.83)]. Additionally, studies reported that Shenmai injection could increase left ventricular stroke volume, decrease left ventricular end systolic diameter, improved hemodynamic indexes, reduced NT-pro-BNP, DMA, cytokines, TNF-alpha, IL-6 and serum enzyme, mitigated infarction-related revascularization IRA indexes and shortened the symptom improvement time and electrocardiogram recovery time. Three studies had reported adverse events, mainly dizziness, palpitation, mild abdominal distension, nausea, metal excitement and flushed face, with no serious adverse effect.

CONCLUSIONClinical evidences prove that Shenmai injection has certain effect in treating CHD and remains to be improved in the overall effective rate. The essay, despite of some shortcomings, provides certain reference for clinical application. It is suggested holding more multicenter randomized controlled trials with rational design, strict implementation, large sample size and sufficient following-up time to further verify its efficacy and safety.

Coronary Artery Disease ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans

BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSION: 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. TRIAL REGISTRATION ChiCTR.org.cn, ChiCTR-TRC-12003513.
Humans ; Coronary Artery Disease/complications* ; Diabetes Mellitus, Type 2/drug therapy* ; Myocardial Infarction/complications* ; Stroke/epidemiology*