One-year clinical outcomes of bivalirudin versus unfractionated heparin in patients with type 2 diabetes undergoing elective percutaneous coronary intervention.

BACKGROUND: Patients with diabetes and coronary artery disease have a higher risk of bleeding and thrombotic events. However, data on the safety and efficacy of bivalirudin in these patients undergoing elective percutaneous coronary intervention (PCI) are lacking. METHODS: 1152 patients undergoing elective PCI anticoagulated with bivalirudin and 10,250 patients anticoagulated with unfractionated heparin (UFH) (with or without glycoprotein IIb/IIIa inhibitors [GPI]) were performed propensity-score matching method. The thrombotic endpoint was major adverse cardiovascular and cerebrovascular events (MACCE). The bleeding endpoint was according to the Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. RESULTS: Finally, 376 (bivalirudin group) and 878 (UFH group) patients with type 2 diabetes (T2D) were enrolled. After one-year follow-up, there were 130 (10.4%) MACCE and 27 (2.2%) bleeding events occurred. Multivariate COX regression analysis showed no significant difference for MACCE between bivalirudin group and UFH group (P > 0.05). Further analysis showed that there was a reduction in the risk of myocardial infarction (MI) between two groups (Hazard ratio [HR] = 0.199, 95% confidence interval [CI]: 0.047-0.845, P = 0.029), but not in the risk of death, revascularization, stent thrombosis or stroke (all P > 0.05). As for BARC 2, 3 or 5 bleeding, no significant difference was found between two groups (P > 0.05). CONCLUSIONS: Although diabetes is considered a high-risk factor for poor prognosis, compared with UFH (with or without GPI), bivalirudin did not increase the risk of MACCE and even decreased the risk of MI in patients with T2D undergoing elective PCI, while the risk of bleeding was similar between two groups.

Independent prognostic value of the congestion and renal index in patients with acute heart failure.

BACKGROUND: Clinical outcomes are poor if patients with acute heart failure (AHF) are discharged with residual congestion in the presence of renal dysfunction. However, there is no single indication to reflect the combined effects of the two related pathophysiological processes. We, therefore, proposed an indicator, congestion and renal index (CRI), and examined the associations between the CRI and one-year outcomes and the incremental prognostic value of CRI compared with the established scoring systems in a multicenter prospective cohort of AHF. METHODS: We enrolled AHF patients and calculated the ratio of thoracic fluid content index divided by estimated glomerular filtration rate before discharge, as CRI. Then we examined the associations between CRI and one-year outcomes. RESULTS: A total of 944 patients were included in the analysis (mean age 63.3 ± 13.8 years, 39.3% women). Compared with patients with CRI ≤ 0.59 mL/min per kΩ, those with CRI > 0.59 mL/min per kΩ had higher risks of cardiovascular death or HF hospitalization (HR = 1.56 [1.13-2.15]) and all-cause death or all-cause hospitalization (HR = 1.33 [1.01-1.74]). CRI had an incremental prognostic value compared with the established scoring system. CONCLUSIONS: In patients with AHF, CRI is independently associated with the risk of death or hospitalization within one year, and improves the risk stratification of the established risk models.

Impact of Diabetes Mellitus on One-Year Clinical Outcomes in Patients Anticoagulated with Bivalirudin Undergoing Elective Percutaneous Coronary Intervention.

Background: Patients with diabetes mellitus (DM) are considered to increase the risk of thrombosis and bleeding. However, whether DM is an independent risk factor for events in patients anticoagulated with bivalirudin during elective percutaneous coronary intervention (PCI) is not clear. Methods: Patients anticoagulated with bivalirudin during elective PCI from January 2017 to August 2018 in 3 centers were enrolled. The primary endpoint of thrombotic events was major adverse cardiac and cerebrovascular events (MACCE, including all-cause death, myocardial infarction, ischemic revascularization, stent thrombosis, and stroke); the primary endpoint of bleeding events was Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. Results: 1152 patients were finally enrolled. After one-year follow-up, 89 (7.7%) MACCE and 21 (1.8%) BARC 2, 3 or 5 bleeding occurred. Multivariate Cox regression analysis showed DM was not an independent risk factor for MACCE (hazard ratio [HR]: 1.029, 95% confidence interval [CI]: 0.674-1.573, P = .893), but peripheral artery disease (PAD) history (HR: 2.200, 95%CI: 1.290-3.751, P = .004) was an independent risk factor for MACCE. DM was not an independent risk factor for BARC 2, 3 or 5 bleeding (HR: 0.732, 95%CI: 0.293-1.831, P = .505), but PAD history (HR: 3.029, 95%CI: 1.102-8.332, P = .032) and low hemoglobin level (HR = 0.972, 95%CI: 0.947-0.998, P = .036) were independent risk factors for BARC 2, 3 or 5 bleeding. Conclusions: DM was not an independent risk factor for one-year thrombotic and bleeding events in patients anticoagulated with bivalirudin during elective PCI. More attention should be paid to PAD history and hemoglobin level to identify high-risk patients.

In-hospital gastrointestinal bleeding in patients with acute myocardial infarction: incidence, outcomes and risk factors analysis from China Acute Myocardial Infarction Registry.

OBJECTIVE: To investigate the incidence of gastrointestinal bleeding (GIB) in patients with acute myocardial infarction (AMI), clarify the association between adverse clinical outcomes and GIB and identify risk factors for in-hospital GIB after AMI. DESIGN: Retrospective cohort study. SETTING: 108 hospitals across three levels in China. PARTICIPANTS: From 1 January 2013 to 31 August 2014, after excluding 2659 patients because of incorrect age and missing GIB data, 23 794 patients with AMI from 108 hospitals enrolled in the China Acute Myocardial Infarction Registry were divided into GIB-positive (n=282) and GIB-negative (n=23 512) groups and were compared. PRIMARY AND SECONDARY OUTCOME MEASURES: Major adverse cardiovascular and cerebrovascular events (MACCEs) are a composite of all-cause death, reinfarction and stroke. The association between GIB and endpoints was examined using multivariate logistic regression and Cox proportional hazards models. Independent risk factors associated with GIB were identified using multivariate logistic regression analysis. RESULTS: The incidence of in-hospital GIB in patients with AMI was 1.19%. GIB was significantly associated with an increased risk of MACCEs both in-hospital (OR 2.314; p<0.001) and at 2-year follow-up (HR 1.407; p=0.0008). Glycoprotein IIb/IIIa (GPIIb/IIIa) receptor inhibitor, percutaneous coronary intervention (PCI) and thrombolysis were novel independent risk factors for GIB identified in the Chinese AMI population (p<0.05). CONCLUSIONS: GIB is associated with both in-hospital and follow-up MACCEs. Gastrointestinal prophylactic treatment should be administered to patients with AMI who receive primary PCI, thrombolytic therapy or GPIIb/IIIa receptor inhibitor. TRIAL REGISTRATION NUMBER: NCT01874691.

Effect of Baseline Thrombocytopenia on Long-Term Outcomes in Patients With Acute ST-Segment Elevated Myocardial Infarction　- A Large Propensity Score-Matching Analysis From the China Acute Myocardial Infarction (CAMI) Registry.

BACKGROUND: Data on the association of baseline thrombocytopenia (TP) with long-term outcomes of patients with acute ST-segment elevated myocardial infarction (STEMI) are still limited.Methods and Results:A total of 16,957 consecutive cases of patients with STEMI from multiple centers that participated in the China Acute Myocardial Infarction (CAMI) registry were included in this study. Two-year clinical outcomes were evaluated between patients with TP and those with a normal platelet count (PLT). Cases coexisting with baseline TP accounted for 2.1%. The rates of 2-year all-cause death (21.4% and 11.4%, P<0.001) and major adverse cardiovascular and cerebrovascular events (MACCE) (23.6% and 13.9%, P<0.001) were significantly higher in cases with TP, compared with the normal PLT group. After multivariate adjustment, compared with the control, cases with TP were not independently associated with 2-year all-cause death (HR: 1.21; 95% CI: 0.96-1.52; P=0.110) and MACCE (HR: 1.18; 95% CI: 0.95-1.47; P=0.132). After propensity score matching (PSM), the rates of 2-year all-cause death and MACCE were similar between the 2 groups (20.7% and 17.9%, P=0.317; 23.0% and 19.9%, P=0.288). Multivariable adjustment after PSM showed baseline TP was not independently associated with all-cause death (HR: 1.21; 95% CI: 0.88-1.67; P=0.240) and MACCE (HR: 1.21; 95% CI: 0.89-1.63; P=0.226). CONCLUSIONS: Patients with STEMI and baseline TP had higher rates of all-cause death and MACCE; however, baseline TP was not independently associated with 2-year adverse outcomes in patients with STEMI after multivariate adjustment and controlling for baseline differences.

Impact of proton pump inhibitors on clinical outcomes in patients after acute myocardial infarction: a propensity score analysis from China Acute Myocardial Infarction (CAMI) registry.

BACKGROUND: Proton pump inhibitors (PPIs) are recommended by the latest guidelines to reduce the risk of bleeding in acute myocardial infarction (AMI) patients treated with dual antiplatelet therapy (DAPT). However, previous pharmacodynamic and clinical studies have reported controversial results on the interaction between PPI and the P2Y12 inhibitor clopidogrel. We investigated the impact of PPIs use on in-hospital outcomes in AMI patients, aiming to provide a new insight on the value of PPIs. METHODS: A total of 23, 380 consecutive AMI patients who received clopidogrel with or without PPIs in the China Acute Myocardial Infarction (CAMI) registry were analyzed. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) defined as a composite of in-hospital cardiac death, re-infarction and stroke. Propensity score matching (PSM) was used to control potential baseline confounders. Multivariate logistic regression analysis was performed to evaluate the effect of PPIs use on MACCE and gastrointestinal bleeding (GIB). RESULTS: Among the whole AMI population, a large majority received DAPT and 67.5% were co-medicated with PPIs. PPIs use was associated with a decreased risk of MACCE (Before PSM OR: 0.857, 95% CI: 0.742-0.990, P = 0.0359; after PSM OR: 0.862, 95% CI: 0.768-0.949, P = 0.0245) after multivariate adjustment. Patients receiving PPIs also had a lower risk of cardiac death but a higher risk of complicating with stroke. When GIB occurred, an alleviating trend of GIB severity was observed in PPIs group. CONCLUSIONS: Our study is the first nation-wide large-scale study to show evidence on PPIs use in AMI patients treated with DAPT. We found that PPIs in combination with clopidogrel was associated with decreased risk for MACCE in AMI patients, and it might have a trend to mitigate GIB severity. Therefore, PPIs could become an available choice for AMI patients during hospitalization.

Effects (MACE and bleeding events) of ticagrelor combined with omeprazole on patients with acute myocardial infarction undergoing primary PCI.

BACKGROUND: This study aimed to investigate the effect of ticagrelor combined with omeprazole on patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI). METHODS: Eighty-six patients with AMI who underwent primary PCI in Xinxiang Central Hospital between July 2015 and December 2016 were included and divided randomly into the observation group and the control group by the draw, with 43 patients in each group. All patients were routinely treated with dual antiplatelet therapy with aspirin plus ticagrelor. Omeprazole was used in the observation group and placebo was used in the control group. Data of baseline patient characteristics, platelet response index (PRI), ADP-induced platelet aggregation (ADP-Ag), major adverse cardiac events (MACE), and incidence of bleeding events were recorded and compared between both groups. RESULTS: PRI and ADP-Ag at 7 days, 1 month, and 6 months after operation in both groups were significantly lower than those in the same group before administration (p < 0.017). Incidence of bleeding events in the observation group was significantly lower than that in the control group (p < 0.05). CONCLUSION: For patients with AMI undergoing primary PCI, omeprazole was found to reduce the incidence of gastrointestinal bleeding without reducing the antiplatelet aggregation effect of ticagrelor or increasing the risk of MACE, which is worthy of clinical promotion.

Association of thrombocytopenia with in-hospital outcome in patients with acute ST-segment elevated myocardial infarction.

This study investigated the association of thrombocytopenia (TP) with in-hospital medication and outcome of patients with acute ST-segment elevated myocardial infarction (STEMI). A total of 16,678 consecutive patients with STEMI from multiple centers that participated in the China Acute Myocardial Infarction registry was included. In-hospital adverse event rates were compared between patients with TP and those with a normal platelet count. Multivariate logistic regression was applied to adjust for confounders. Propensity score matching (PSM) was applied to control for baseline differences. There were 359 patients with baseline TP, accounting for 2.2% of the total cohort. The risk of in-hospital death (11.1% vs 6.0%, P < 0.001); major adverse cardiovascular events (MACE) (11.7% vs 6.4%, P < 0.001); and newly occurred or aggravated heart failure, cardiogenic shock, malignant arrhythmia, acute pulmonary embolism, and bleeding (3.6% vs 1.8%, P = 0.024) were significantly higher in the TP group than in the normal platelet group. After multivariate adjustment, TP was independently associated only with malignant arrhythmia (odds ratio: 1.49; 95% confidence interval: 1.09-2.05, P = 0.014). A total of 289 patients in each group were matched by PSM. The risk of all endpoints was not significantly different between the two matched groups before and after multivariate adjustment. In-hospital outcomes were worse in patients with STEMI and TP than in those with a normal platelet count. However, baseline TP was not independently associated with in-hospital death, MACE, or bleeding risk after multivariate adjustment and controlling for baseline differences.

Effect of telmisartan and enalapril on ventricular remodeling and kidney prognosis of patients with coronary artery disease complicated with diabetic nephropathy.

The aim of the present study was to compare the value of telmisartan and enalapril on ventricular remodeling and kidney prognosis of patients with coronary artery disease complicated with diabetic nephropathy, and provide discussion on clinical reasonably chosen medicine. A total of 60 cases of coronary artery disease complicated with diabetic nephropathy were randomly divided for telmisartan (80 mg/day) treatment (n=32), enalapril (10 mg/day) treatment (n=28), while the rest of the therapy was kept the same. After 12 weeks, the clinical effects were compared between different groups. It was found that in comparison with enalapril group, the left ventricular ejection fraction of telmisartan group was significantly higher, and left ventricular end-diastolic diameter was significantly lower (P<0.05). The serum creatinine level and 24-h protein of telmisartan group were significantly lower than that for the enalapril group (P<0.05). In conclusion, the regular telmisartan treatment for patients with coronary artery disease complicated with diabetic nephropathy is better than enalapril on ventricular remodeling and kidney prognosis.

[Analysis of spontaneous reperfusion in acute myocardial infarction and its effect on short-term prognosis].

OBJECTIVE: To analyse the clinical and angiographic characteristics of spontaneous reperfusion (SR) in AMI, and to evaluate its effect on short-term prognosis. METHODS: 112 consecutive AMI patients without intravenous thrombolytic therapy received emergent coronary angiography and primary PCI. The patients were divided into SR group (antegrade TIMI grade 2-3 flow) and non-SR group (antegrade TIMI grade 0-1 flow). The clinical, angiographic and prognostic features of the patients were analyzed. RESULTS: 31 patients (27.7%) were in SR group, and there was no significant difference in base-line clinical characteristics between the two groups. Compared with non-SR group, peak values of CK and CK-MB, Ventricular wall motion abnormality and mortality were lower in SR group, ejection fraction was higher in SR group. Logistic regression analysis showed that there was good correlation between SR and peak value of CK, collaterals, ventricular wall motion abnormality and pre-dilation in PCI. CONCLUSION: SR decreased infarction size, improved heart function and reduced 30-day mortality.