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Concept: Acute coronary syndrome

252

Background To assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome. Methods We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Results A total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower with alogliptin than with placebo (mean difference, -0.36 percentage points; P<0.001). Incidences of hypoglycemia, cancer, pancreatitis, and initiation of dialysis were similar with alogliptin and placebo. Conclusions Among patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT00968708 .).

Concepts: Myocardial infarction, Atherosclerosis, Hypertension, Angina pectoris, Diabetes mellitus, Obesity, Cardiovascular disease, Acute coronary syndrome

214

Proton pump inhibitors (PPIs) have been associated with adverse clinical outcomes amongst clopidogrel users after an acute coronary syndrome. Recent pre-clinical results suggest that this risk might extend to subjects without any prior history of cardiovascular disease. We explore this potential risk in the general population via data-mining approaches.

Concepts: Myocardial infarction, Atherosclerosis, Angina pectoris, Heart, The Canon of Medicine, Cardiovascular disease, Clopidogrel, Acute coronary syndrome

199

We aimed to derive and validate a clinical decision rule (CDR) for suspected cardiac chest pain in the emergency department (ED). Incorporating information available at the time of first presentation, this CDR would effectively risk-stratify patients and immediately identify: (A) patients for whom hospitalisation may be safely avoided; and (B) high-risk patients, facilitating judicious use of resources.

Concepts: Myocardial infarction, Hospital, Heart, Validation, Avicenna, Decision theory, Acute coronary syndrome, Chest pain

146

The Global Registry of Acute Coronary Events (GRACE) risk score has been extensively validated to predict risk during hospitalization in patients with acute coronary syndrome (ACS). Recently, serum calcium has been suggested as an independent predictor for in-hospital mortality in patients with ST-segment elevation myocardial infarction; however, the relationship between the 2 has not been evaluated.

Concepts: Myocardial infarction, Atherosclerosis, Angina pectoris, Hospital, Cardiology, Acute coronary syndrome, Calcium metabolism, Emergency department

146

The aim of this study was to investigate the prognostic impact of acute-phase ventricular tachycardia and fibrillation (VT/VF) on ST-segment elevation myocardial infarction (STEMI) patients in the percutaneous coronary intervention (PCI) era.Methods and Results:Using the database of the Osaka Acute Coronary Insufficiency Study (OACIS), we studied 4,283 consecutive patients with STEMI who were hospitalized within 12 h of STEMI onset and underwent emergency PCI. Acute-phase VT/VF, defined as ≥3 consecutive ventricular premature complexes and/or VF within the 1st week of hospitalization, occurred in 997 (23.3%) patients. In-hospital mortality risk was significantly higher in patients with acute-phase VT/VF than inthose without (14.6% vs. 4.3%, adjusted hazard ratio (HR) 1.83, P=0.0013). Among patients discharged alive, 5-year mortality rates were comparable between patients with and without acute-phase VT/VF. Subgroup analysis showed that acute-phase VT/VF was associated with increased 5-year mortality after discharge in high-risk patients (GRACE Risk Score ≥115; adjusted HR 1.60, P=0.043), but not in intermediate- or low-risk patients.

Concepts: Myocardial infarction, Atherosclerosis, Cardiology, Percutaneous coronary intervention, Ventricular tachycardia, Acute coronary syndrome, Ventricular fibrillation, Premature ventricular contraction

141

Several randomized controlled trials have shown a benefit of high-dose intensive statin treatment in reducing risk of death and second cardiovascular disease (CVD) events in patients previously diagnosed with an acute coronary syndrome (ACS). Non-randomized studies in clinical settings support these findings, but large, long-term, observational studies addressing CVD and non-CVD endpoints are lacking. In this retrospective longitudinal study, we followed ACS patients in Sweden during 2001-2012 using national health registry and medical record data. A total of 49,857 patients were identified, of whom 10,092 (20.2%) received high dose statins and 21,174 (42.7%) received no statins. Royston-Parmar parametric time-to-event models were implemented to model hazard for second CVD events and death, stratified by gender and diabetes diagnosis. We found that risk of a second CVD event developed similarly in both treatment groups, but was much higher in the no statin group. Risk of CVD-related death remained relatively constant for the high-statin group, while it increased over time for the no-statin group. Interestingly, males had higher mortality rates in the no-statin group, but not in the high-statin group. All-cause mortality and non-CVD-related death followed similar trends to those observed for CVD-related death. This work provides additional real-world evidence for effect of statins in CVD-related mortality. The hazard functions presented here can provide a basis for future survival modeling and health economic evaluation.

Concepts: Epidemiology, Myocardial infarction, Atherosclerosis, The Canon of Medicine, Cardiovascular disease, Randomized controlled trial, Low-density lipoprotein, Acute coronary syndrome

139

The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS).

Concepts: Angina pectoris, Cardiology, Acute coronary syndrome, Syndrome

136

Early myocardial reperfusion therapy ( < 12 h) in patients with acute myocardial infarction (AMI) can significantly improve their prognosis. However, the effect of late reperfusion ( > 12 h) remains controversial. In this study, the effects of late reperfusion versus standard drug therapy on the outcomes of patients with AMI were evaluated by systematic review and meta-analysis.

Concepts: Myocardial infarction, Atherosclerosis, Medical terms, Systematic review, Infarction, Troponin, Meta-analysis, Acute coronary syndrome

136

To examine the prognosis of patients with cardiovascular and non-cardiovascular multimorbidity after acute coronary syndrome compared to patients without prior multimorbidity.

Concepts: Medical terms, Acute coronary syndrome

76

Background The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. Methods In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. Results A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). Conclusions Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy. (Funded by the Swedish Heart-Lung Foundation and others; VALIDATE-SWEDEHEART ClinicalTrialsRegister.eu number, 2012-005260-10 ; ClinicalTrials.gov number, NCT02311231 .).

Concepts: Myocardial infarction, Atherosclerosis, Heart failure, Percutaneous coronary intervention, Atheroma, Clopidogrel, Acute coronary syndrome, Anticoagulant