Dongfeng Zhang

BleeMACS: rationale and design of the study.

Background Bleeding events after an acute coronary syndrome have a negative impact on prognosis. Available risk scores are limited by suboptimal accuracy, prediction of only in-hospital events and absence of patients treated with new antiplatelet agents in the current era of widespread use of percutaneous coronary intervention. Design The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged after an Acute Coronary Syndrome) project is a multicenter investigator-initiated international retrospective registry that enrolled more than 15 000 patients discharged with a definitive diagnosis of acute coronary syndrome and treated with percutaneous revascularization. The primary end point is the incidence of major bleeding events requiring hospitalization and/or red cell transfusion concentrates within 1 year. An integer risk score for bleeding within the first year after hospital discharge will be developed from a multivariate competing-risks regression. Conclusion The BleeMACS registry collaborative will allow development and validation of a risk score for prediction of major bleeding during follow-up for patients receiving contemporary therapies for acute coronary syndrome.

Impact of blood transfusion on in-hospital myocardial infarctions according to patterns of acute coronary syndrome: Insights from the BleeMACS registry

BACKGROUND Blood transfusions (BTs) may worsen the prognosis of patients affected by acute coronary syndromes (ACS), although few data detail their impact on short-term events according to clinical presentation (ST Segment Elevation Myocardial Infarction, STEMI vs. Non-ST Segment Elevation ACS, NSTE-ACS). METHODS Patients undergoing percutaneous coronary intervention (PCI) for ACS, with data on BTs, were selected from the BleeMACS registry. The primary end point was the incidence of myocardial infarction during hospitalization (reAMI), the secondary end-points were 30-day mortality and the combined end-point of 30-day mortality and reAMI. Sensitivity analyses were performed according to clinical presentation (STEMI vs. NSTE-ACS). RESULTS Overall, 13,975 patients were included: mean age was 64.1years, 10,651 (76.2%) were male and 7711 (55.2%) had STEMI. BTs were administered during hospitalization to 465 (3.3%) patients, who were older and presented a more relevant burden of risk factors. The primary end-point of reAMI occurred in 197 (1.4%) patients, of whom 102 (1.1%) with STEMI. After controlling for confounding variables, BTs independently predicted the primary end-point reAMI in patients admitted for STEMI (OR 4.059, 95% CI 2244-7.344) and not in those admitted for NSTE-ACS. Moreover, BTs independently related to 30-day mortality in STEMI and NSTE-ACS patients and to the composite of 30-day mortality and reAMI in STEMI patients. CONCLUSIONS In patients undergoing PCI for ACS, BTs increase the risk of reAMI only in those admitted for STEMI, and not in those with NSTE-ACS. These results may help physicians to choose appropriate BT administration according to the admission diagnosis.

Prevalence and outcome of patients with cancer and acute coronary syndrome undergoing percutaneous coronary intervention: a BleeMACS substudy

Background: The prevalence and outcome of patients with cancer that experience acute coronary syndrome (ACS) have to be determined. Methods and results: The BleeMACS project is a multicentre observational registry enrolling patients with acute coronary syndrome undergoing percutaneous coronary intervention worldwide in 15 hospitals. The primary endpoint was a composite event of death and re-infarction after one year of follow-up. Bleedings were the secondary endpoint. 15,401 patients were enrolled, 926 (6.4%) in the cancer group and 14,475 (93.6%) in the group of patients without cancer. Patients with cancer were older (70.8±10.3 vs. 62.8±12.1 years, P<0.001) with more severe comorbidities and presented more frequently with non-ST-segment elevation myocardial infarction compared with patients without cancer. After one year, patients with cancer more often experienced the composite endpoint (15.2% vs. 5.3%, P<0.001) and bleedings (6.5% vs. 3%, P<0.001). At multiple regression analysis the presence of cancer was the strongest independent predictor for the primary endpoint (hazard ratio (HR) 2.1, 1.8–2.5, P<0.001) and bleedings (HR 1.5, 1.1–2.1, P=0.015). Despite patients with cancer generally being undertreated, beta-blockers (relative risk (RR) 0.6, 0.4–0.9, P=0.05), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (RR 0.5, 0.3–0.8, P=0.02), statins (RR 0.3, 0.2–0.5, P<0.001) and dual antiplatelet therapy (RR 0.5, 0.3–0.9, P=0.05) were shown to be protective factors, while proton pump inhibitors (RR 1, 0.6–1.5, P=0.9) were neutral. Conclusion: Cancer has a non-negligible prevalence in patients with acute coronary syndrome undergoing percutaneous coronary intervention, with a major risk of cardiovascular events and bleedings. Moreover, these patients are often undertreated from clinical despite medical therapy seems to be protective. Registration:The BleeMACS project (NCT02466854).

Effect of Coronary Collaterals on Prognosis in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Meta-Analysis

The impact of coronary collaterals on the prognosis in patients with acute ST-segment elevation myocardial infarction (STEMI) in the era of coronary revascularization remains controversial. The purpose of this meta-analysis was to investigate the effect of coronary collateral on clinical outcomes, especially mortality (≥6 months), in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. Eligible observational studies were selected by searching PubMed, EMBASE, and Cochrane Library up to August 9, 2017. Overall, 14 observational studies involving 10 411 patients were included. Coronary collaterals were found to reduce the risk of long-term mortality (≥6 months; risk ratio [RR]: 0.65, 95% confidence interval [CI]: 0.55-0.76) as well as in-hospital plus 30-day mortality (RR: 0.61, 95% CI: 0.47-0.78) in patients undergoing PCI for STEMI. In addition, pooling the risk-adjusted or propensity-matched data showed a significant reduction in long-term mortality (RR: 0.68, 95% CI: 0.49-0.95) and in-hospital plus 30-day mortality (RR: 0.27, 95% CI: 0.13-0.55) in patients with collateral circulation. However, no significant difference was found in the risk of recurrent myocardial infarction and target vessel revascularization between the 2 groups. Therefore, it was found that coronary collaterals have a beneficial effect on long-term survival (≥6 months) as well as in-hospital plus 30-day survival in patients undergoing primary PCI for STEMI.

Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention in Patients With Left Ventricular Systolic Dysfunction A Meta-Analysis

The optimal method of coronary revascularization for patients with coronary artery disease (CAD) and left ventricular (LV) systolic dysfunction is unclear. The purpose of this meta-analysis was to compare coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in these patients. Two investigators independently searched PubMed, EMBASE, and the Cochrane Controlled Trials Register databases for relevant studies. Four prospective and 5 retrospective studies, published before March 2015, involving 6082 patients were included. Compared with PCI, CABG was significantly associated with lower long-term death (odds ratio [OR]: 0.82, 95% confidence interval [CI]: 0.70-0.96, P = .01, I 2 = 0%), myocardial infarction (OR: 0.58, 95% CI: 0.36-0.95, P = .03, I 2 = 44%), and repeat revascularization (OR: 0.17, 95% CI: 0.14-0.22, P < .001, I 2 = 32%). The short-term death rate was comparable between CABG and PCI (OR: 2.09, 95% CI: 0.80-5.45, P = .13, I 2 = 9%). Coronary artery bypass grafting has long-term benefits compared with PCI in patients with CAD and LV dysfunction.

Prediction of Post-Discharge Bleeding in Elderly Patients with Acute Coronary Syndromes: Insights from the BleeMACS Registry

BACKGROUND A poor ability of recommended risk scores for predicting in-hospital bleeding has been reported in elderly patients with acute coronary syndromes (ACS). No study assessed the prediction of post-discharge bleeding in the elderly. The new BleeMACS score (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome), was designed to predict post-discharge bleeding in ACS patients. We aimed to assess the predictive ability of the BleeMACS score in elderly patients. METHODS We assessed the incidence and characteristics of severe bleeding after discharge in ACS patients aged ≥ 75 years. Bleeding was defined as any intracranial bleeding or bleeding leading to hospitalization and/or red blood transfusion, occurring within the first year after discharge. We assessed the predictive ability of the BleeMACS score according to age by Fine-Gray proportional hazards regression analysis, calculating receiver-operating characteristic (ROC) curves and the area under the ROC curves (AUC). RESULTS The BleeMACS registry included 15,401 patients of whom 3,376/15,401 (21.9%) were aged ≥ 75 years. Elderly patients were more commonly treated with clopidogrel and less often treated with ticagrelor or prasugrel. Of 3,376 elderly patients, 190 (5.6%) experienced post-discharge bleeding. The incidence of bleeding was moderately higher in elderly patients (hazard ratio [HR], 2.31, 95% confidence interval [CI], 1.92-2.77). The predictive ability of the BleeMACS score was moderately lower in elderly patients (AUC, 0.652 vs. 0.691, p = 0.001). CONCLUSION Elderly patients with ACS had a significantly higher incidence of post-discharge bleeding. Despite a lower predictive ability in older patients, the BleeMACS score exhibited an acceptable performance in these patients.

Gender-related differences in post-discharge bleeding among patients with acute coronary syndrome on dual antiplatelet therapy: A BleeMACS sub-study

INTRODUCTION Bleeding is an independent risk factor of mortality in patients with acute coronary syndromes (ACS). BleeMACS project focuses on long-term bleeding events after hospital discharge, thus we evaluated gender-related differences in post-discharge bleeding among patients with ACS. MATERIALS AND METHODS We investigated 13,727 ACS patients treated with percutaneous coronary intervention and discharged on dual antiplatelet therapy (either with clopidogrel or prasugrel/ticagrelor). Endpoint was defined as intracranial bleeding or any other bleeding leading to hospitalization and/or red blood transfusion. RESULTS Post-discharge bleeding was reported more frequently in females as compared with males (3.7% vs. 2.7%, log-rank P = 0.001). Females (n = 3165, 23%) were older compared to men (69.0 vs. 61.5 years, P < 0.001) and with more comorbidities. Hence, in multivariate analysis female sex was not identified as an independent risk factor of bleeding (HR 1.012, CI 0.805 to 1.274, P = 0.816). Administration of newer antiplatelet agents compared to clopidogrel was associated with over twofold greater bleeding rate in females (7.3% vs. 3.5%, log-rank P = 0.004), but not in males (2.6% vs. 2.7%, log-rank P = 0.887). Differences among females remained significant after propensity score matching (7.2% vs 2.4%, log-rank P = 0.020) and multivariate analysis confirmed that newer antiplatelet agents are independent risk factor for bleeding only in women (HR 2.775, CI 1.613 to 4.774, P < 0.001). CONCLUSIONS Bleeding events occurred more frequently in women, but female sex itself was not independent risk factor. Administration of newer antiplatelet agents was identified as independent risk factor of bleeding after hospital discharge in female gender, but not in male patients.

Stent Versus Non-Stent in Treating Intermediate Stenosis Culprit Lesions in Acute ST-Segment Elevation Myocardial Infarction Patients

To investigate the efficacy and safety of stent versus non-stent in treating acute ST-segment elevation myocardial infarction (STEMI) patients with single vessel disease and intermediate stenosis culprit lesions.Between September 2009 and May 2015, 475 acute STEMI patients (time from symptom onset < 12 hours) with single vessel disease and intermediate stenosis culprit lesions were retrospectively studied at Beijing Anzhen Hospital. The patients were divided into a stent group (n = 308) and non-stent group (n = 167) based on whether they received stent implantation or not during primary coronary angiography.During follow-up, the stent group patients had a lower major adverse cardiac and cerebrovascular event (MACCE) rate than the non-stent group: 5.5% versus 12.0%; P = 0.01; hazard ratio (HR) 0.35 [95% confidence interval (CI): 0.180.69]). The nonfatal myocardial infarction (MI) rate was lower in the stent group (2.9% versus 7.2%, P = 0.03). The cardiac death rate (1.9% versus 3%, P = 0.45) and stroke (0.6% versus 1.8%, P = 0.35) rate were similar between the stent and non-stent groups. The two groups shared similar all cause death rates: 4.9% versus 5.4%, respectively, P = 0.81; HR: 1.23 [95%CI: 0.51-2.99]. The composite ischemia outcome of death/MI/stroke was lower in the stent group (8.1% versus 14.4%, P = 0.02). The stent and non-stent groups had similar repeat revascularization rates (10.1% versus 11.4%, P = 0.67); ischemia driven readmission (19.5% versus 15.0%, P = 0.27), and bleeding (1.3% versus 1.2%, P = 1) rates.Stent implantation has a better efficacy and safety in reducing adverse ischemia events in acute STEMI patients with single vessel disease and intermediate stenosis culprit lesions.

Prognostic performance of interleukin-10 in patients with chest pain and mild to moderate coronary artery lesions-an 8-year follow-up study.

Background Interleukin (IL)-10, IL-6 and their ratio (IL-6/IL-10) play an important role in the risk of developing coronary artery disease, and may correlate with its outcomes. Few clinical trials have investigated the prognostic impact of these factors on long-term cardiovascular events in patients presented with chest pain. Methods A prospective study was performed on 566 patients admitted with chest pain and identified mild to moderate coronary artery lesions. IL-10, IL-6 and IL-6/IL-10 were measured. Results A total of 511 patients completed the follow-up. The median follow-up time was 74 months. Kaplan-Meier analysis demonstrated a clear increase of the incidence of major adverse cardiac events during the follow-up period in patients with below-median levels of IL-10 (P = 0.006) and above-median levels of IL-6/IL-10 (P = 0.012). Multivariate Cox proportional hazards analysis indicated the IL-10 levels to be strong independent predictors after adjustment for underlying confounders. Conclusions Elevated IL-10 levels are associated with a more favorable long-term prognosis in patients with chest pain and mild to moderate coronary artery lesions. IL-10 could be used for early risk assessment of long-term prognosis.

Meta-Analysis Comparing Percutaneous Coronary Revascularization Using Drug-Eluting Stent Versus Coronary Artery Bypass Grafting in Patients With Left Ventricular Systolic Dysfunction

The relative safety and efficacy of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) and coronary artery bypass grafting (CABG) in patients with left ventricular (LV) systolic dysfunction remains controversial; therefore we conducted this meta-analysis to identify the optimal strategy for such cohorts. A comprehensive search of the electronic databases including PubMed, EMBASE, and Cochrane Library from January 1, 2003 to March 1, 2018 was performed to identify the eligible adjusted observational studies. The primary end point was all-cause death during the longest follow-up, and the generic inverse variance random-effect model was used to estimate the pooled hazard ratios (HRs) with 95% confidence intervals (CIs). Eight adjusted observational studies involving 10,268 patients were included. Compared with CABG, PCI with DES was associated with higher risk of all-cause mortality (HR 1.36, 95% CI 1.16 to 1.60), cardiac mortality (HR 2.20, 95% CI 1.63 to 2.95), myocardial infarction (HR 1.69, 95% CI 1.28 to 2.24), and repeat revascularization (HR 4.95, 95% CI 3.28 to 7.46) in patients with coronary artery disease and LV systolic dysfunction. Besides, separate analysis of patients with LV ejection fraction <35% or left main and/or multivessel disease obtained similar results compared with the overall analysis. However, DES and CABG shared similar rates of stroke (HR 0.92, 95% CI 0.67 to 1.26). In conclusion, CABG appears to be superior to PCI with DES for patients with coronary artery disease and LV systolic dysfunction, particularly in patients with severe LV systolic dysfunction or those with left main and/or multivessel disease.