Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice.

BACKGROUND: Cardiovascular diseases (CVD) contribute considerably to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention. In the Netherlands an integrated programme for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in primary care in many regions in recent years, but its effects are unknown. In the ZWOT-CASE study we will assess the effect of integrated care for CVRM in the region of Zwolle on two major cardiovascular risk factors: systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-cholesterol) in patients with or at high risk of CVD. METHODS: This study is a pragmatic observational study comparing integrated care for CVRM with usual care among patients aged 40-80 years with CVD (n = 370) or with a high CVD risk (n = 370) within 26 general practices. After 1 yr follow-up, primary outcomes (SBP and LDL-cholesterol level) are measured. Secondary outcomes include lifestyle habits (smoking, dietary habits, alcohol use, physical activity), risk factor awareness, 10-year risk of cardiovascular morbidity or mortality, health care consumption, patient satisfaction and quality of life. CONCLUSION: The ZWOT-CASE study will provide insight in the effects of integrated care for CVRM in general practice in patients with CVD or at high CVD risk. TRIAL REGISTRATION: The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study; ClinicalTrials.gov ; Identifier: NCT03428061; date of registration: 09-02-2018; This study has been retrospectively registered.

Pre-hospital administration of tirofiban in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: a sub-analysis of the On-Time 2 trial.

AIMS: Glycoprotein IIb/IIIa blocking agents seem to improve percutaneous coronary intervention (PCI) results in patients with ST-elevation myocardial infarction (STEMI). We aimed to compare the effect of pre-hospital administration of tirofiban in STEMI patients with and without diabetes mellitus (DM) treated with primary PCI. METHODS AND RESULTS: We performed a pre-specified sub-analysis of the randomised On-Time II trial (n=984) and it's open label run-in phase (n=414), which investigated pre-hospital administration of high dose tirofiban in STEMI patients treated with primary PCI. Two-hundred and twenty (16%) diabetic patients (known DM or Hba1C ≥6.2%) were included, 101 in the placebo group and 119 in the tirofiban group. In patients with DM, randomisation to tirofiban resulted in a lower residual ST deviation (5.1±8.5 mm vs. 6.2±5.6 mm, p=0.003), a reduced infarct size (CK 1694±1925 U/L vs. CK 2040±1829 U/L, p=0.02) and a trend towards lower one-year mortality (4.6% vs. 11.6%, p=0.07). The beneficial effects of tirofiban were more pronounced in diabetic patients compared to patients without diabetes. CONCLUSIONS: Pre-hospital administration of tirofiban in diabetic STEMI patients treated with primary PCI improves ST resolution and reduces myocardial infarct size. Tirofiban seems particularly beneficial in patients with diabetes.

Glucose-insulin-potassium and reperfusion in acute myocardial infarction: rationale and design of the Glucose-Insulin-Potassium Study-2 (GIPS-2).

BACKGROUND: The combination of reperfusion therapy and high-dose glucose-insulin-potassium (GIK) infusion seems beneficial in acute myocardial infarction (MI). Current evidence, however, is not considered conclusive. STUDY DESIGN: The Glucose-Insulin-Potassium Study-2 (GIPS-2) will investigate whether GIK, in adjunction to reperfusion therapy, is beneficial in MI patients without signs of heart failure at admission. A total of at least 1044 patients with an acute MI treated with either thrombolysis or primary percutaneous coronary intervention will be randomized to an infusion of high-dose GIK or no infusion. The primary end point of the study is 30-day mortality. Secondary end points are mortality at 1 year, recurrence of MI, repeat intervention, and infarct size. IMPLICATIONS: If high-dose GIK significantly reduces mortality at 30 days in all patients, the adjunction of this treatment to reperfusion therapy may become part of standard regimen for patients with acute MI without heart failure.

Glucose-insulin-potassium infusion as adjunctive therapy in myocardial infarction: current evidence and potential mechanisms.

BACKGROUND: In ST-elevation myocardial infarction (STEMI) there is conflicting evidence that mortality, morbidity and infarct size is reduced by therapies influencing myocardial metabolism, such as infusion of glucose-insulin-potassium (GIK). Several clinical trials with GIK have already provided insight into the magnitude of this effect. The aim of this article was to review randomized trials on adjunctive GIK infusion in STEMI. METHODS: Randomized trials comparing GIK with placebo or untreated controls in patients with STEMI were identified by electronic and manual searches. A systematic analysis of all data was performed, with regard to inclusion criteria, dose of GIK and additional use of reperfusion therapy. Thirteen trials, involving 4992 patients, were included. RESULTS: Overall, hospital mortality was 10.8% after GIK compared to 12.9% in controls (p = 0.02). GIK infusions were in particular effective when a high dose was used and if given as an adjunct to reperfusion therapy. In patients with heart failure on admission, GIK may have worse effects. In all analyzed trials, GIK infusion caused only mild adverse effects, although fluid overload may be a problem in certain patients. CONCLUSIONS: GIK may reduce mortality in patients with STEMI, particularly if a high dose is used and when GIK is administered as an adjunct to reperfusion therapy. However, all studies had a relative small sample size and additional large randomized trials are certainly needed before a definite conclusion can be made. The limited evidence currently available does not warrant GIK therapy to be applied in patients at the present time.