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One-Year Outcome of Intensive Insulin Therapy Combined to Glucose-Insulin-Potassium in Acute Coronary Syndrome: A Randomized Controlled Study.

ABSTRACT: A number of factors may offset the cardioprotective effects of glucose-insulin-potassium (GIK) on outcome of patients with acute coronary syndrome, such as hyperglycemia induced by this cocktail infusion. We performed a study to evaluate the effect of intensive insulin therapy in association with GIK on 1-year outcome in patients hospitalized for acute coronary syndrome.In a randomized prospective controlled trial we included 772 patients with non-ST-segment elevation acute coronary syndrome. Patients were randomized into 3 groups: GIKI2 group, who received GIK with intensive insulin therapy for 24 hours; GIK group, who received GIK with nonintensive insulin therapy; and control group, who received usual care. The primary outcome criteria were the rates of major cardiovascular events combining death, reinfarction, and stroke rate at 1 year. In addition, we measured platelet function assay-100 and plasminogen activator inhibitor-1 at admission and 24 hours later. Based on an intention-to-treat analysis, major cardiovascular events at 1 year was 12.8% in the GIKI2 group, 15.5% in the GIK group, and 20.5% in the placebo group; the difference was significant between the GIK2 and control groups (P=0.01). Platelet function assay-100 at 24 hours decreased significantly from baseline in the control group but not in the GIKI2 group. Plasminogen activator inhibitor-1 decreased significantly in the GIKI2 group but significantly increased in the control group. Minor hypoglycemic events were more frequent in the GIKI2 group compared with other groups.GIKI2 led to improvement of 1-year outcome rates in patients with non-ST-segment elevation acute coronary syndrome. This beneficial effect was associated with a decrease in platelet reactivity and an increase on fibrinolysis tests.URL: https://www.clinicaltrials.gov. Unique identifier: NCT00965406.

SUBMITTER: Bouida W

PROVIDER: S-EPMC5721763 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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One-Year Outcome of Intensive Insulin Therapy Combined to Glucose-Insulin-Potassium in Acute Coronary Syndrome: A Randomized Controlled Study.

Bouida Wahid W Beltaief Kaouthar K Msolli Mohamed Amine MA Bzeouich Nasri N Sekma Adel A Echeikh Malek M Mzali Malek M Boubaker Hamdi H Grissa Mohamed Habib MH Boukef Riadh R Hassine Mohsen M Dridi Zohra Z Belguith Asma A Najjar Fadhel F Khochtali Ines I Nouira Semir S

Journal of the American Heart Association 20171114 11

<h4>Background</h4>A number of factors may offset the cardioprotective effects of glucose-insulin-potassium (GIK) on outcome of patients with acute coronary syndrome, such as hyperglycemia induced by this cocktail infusion. We performed a study to evaluate the effect of intensive insulin therapy in association with GIK on 1-year outcome in patients hospitalized for acute coronary syndrome.<h4>Methods and results</h4>In a randomized prospective controlled trial we included 772 patients with non-S ...[more]

PMID: 29138181

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Project description:BACKGROUND:Most evidence regarding the efficacy and safety of the antithrombotic regimens for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI-S) derives from small, single-center, retrospective datasets. To obtain further data on this issue, we carried out the prospective, multicenter, observational Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) registry (Clinicaltrials.gov identifier NCT00596570). HYPOTHESIS:We hypothesize that the antithrombotic treatment of AF patients undergoing PCI-S is variable and the clinical outcome may vary according to the different regimens. METHODS:Consecutive AF patients undergoing PCI-S at 17 European institutions were included and followed for 1 year. Outcome measures included: (1) major adverse cardiac/cerebrovascular events (MACCE), including all-cause death, myocardial infarction, repeat revascularization, stent thrombosis, or stroke/transient ischemic attack, and (2) bleeding, and were compared according to the antithrombotic regimen adopted. A propensity-score analysis was carried out to adjust for baseline and procedural differences. RESULTS:Out of the 975 patients enrolled, 914 were included in the final analysis. The mean CHADS2 score was 2.2 ± 1.2, and 71% of patients had a CHADS2 score ?2. Triple therapy (TT) of vitamin K antagonist (VKA), aspirin, and clopidogrel was prescribed to 74% of patients, dual antiplatelet therapy to 18%, and VKA plus clopidogrel to 8%. At 1-year follow-up, no significant differences were found in the occurrence of MACCE and bleeding among the 3 antithrombotic regimens, even when adjusted for propensity score. CONCLUSIONS:In this large, real-world population of AF patients undergoing PCI-S, TT was the antithrombotic regimen most frequently prescribed. Although several limitations need to be acknowledged, in our study the 1-year efficacy and safety of TT, dual antiplatelet therapy, and VKA plus clopidogrel was comparable.

Project description:OBJECTIVE: To investigate comorbid conditions with prognostic influence in non-ST-segment elevation acute coronary syndrome (NSTEACS). PATIENTS AND METHODS: The study group consisted of a derivation cohort of 1017 patients (admitted from October 1, 2002, through October 1, 2008) and an external validation cohort of 652 patients (admitted from February 1, 2006, through September 30, 2009). Comorbid conditions, including risk factors and components of the Charlson comorbidity index (ChCI) and coronary artery disease-specific index, were recorded. The main outcome was one-year mortality. RESULTS: During follow-up, 103 patients died. After adjusting for variables associated with NSTEACS characteristics (base model), 5 comorbid conditions predicted mortality: severe or mild renal failure (hazard ratio [HR], 2.9 and HR, 1.6, respectively), dementia (HR, 3.1), peripheral artery disease (HR, 2.0), previous heart failure (HR, 2.6), and previous myocardial infarction (HR, 1.4). A simple comorbidity index (SCI) was developed using these variables, (per point: HR, 1.6; 95% confidence interval, 1.4-1.8; P = .0001). Adding the SCI, Charlson comorbidity index, or coronary artery disease-specific index to the base model resulted in a gain of 6.58%, 5.00%, and 4.04%, respectively, in discriminative ability (P = .001), without significant differences among the 3 indices. In patients with comorbid conditions, the highest risk period was in the first weeks after NSTEACS. The strength of the association between SCI and mortality rate was similar in the external validation cohort (HR, 1.3; 95% confidence interval, 1.1-1.6; P = .001). CONCLUSION: Renal dysfunction, dementia, peripheral artery disease, previous heart failure, and previous myocardial infarction are the comorbid conditions that predict mortality in NSTEACS. A simple index using these variables proved to be as accurate as the more complex comorbidity indices for risk stratification. In-hospital management of patients with comorbid conditions merits further investigation.

Dataset Information

One-Year Outcome of Intensive Insulin Therapy Combined to Glucose-Insulin-Potassium in Acute Coronary Syndrome: A Randomized Controlled Study.

Publications

One-Year Outcome of Intensive Insulin Therapy Combined to Glucose-Insulin-Potassium in Acute Coronary Syndrome: A Randomized Controlled Study.

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