Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis. (Funded by the Medicines Company; EUROMAX ClinicalTrials.gov number, NCT01087723.).
AimsIn the HORIZONS trial, in-hospital treatment with bivalirudin reduced bleeding and mortality in primary percutaneous coronary intervention (PCI) compared with heparin and routine glycoprotein IIb/IIIa inhibitors (GPI). It is unknown whether this advantage of bivalirudin is observed in comparison with heparins only with GPI used as bailout.Methods and resultsIn the EUROMAX study, 2198 patients with ST-segment elevation myocardial infarction (STEMI) were randomized during transport for primary PCI to bivalirudin or to heparins with optional GPI. Primary and principal outcome was the composites of death or non-CABG-related major bleeding at 30 days. This pre-specified analysis compared patients receiving bivalirudin (n = 1089) with those receiving heparins with routine upstream GPI (n = 649) and those receiving heparins only with GPI use restricted to bailout (n = 460). The primary outcome death and major bleeding occurred in 5.1% with bivalirudin, 7.6% with heparin plus routine GPI (HR 0.67 and 95% CI 0.46–0.97, P = 0.034), and 9.8% with heparins plus bailout GPI (HR 0.52 and 95% CI 0.35–0.75, P = 0.006). Following adjustment by logistic regression, bivalirudin was still associated with significantly lower rates of the primary outcome (odds ratio 0.53, 95% CI 0.33–0.87) and major bleeding (odds ratio 0.44, 95% CI 0.24–0.82) compared with heparins alone with bailout GPI. Rates of stent thrombosis were higher with bivalirudin (1.6 vs. 0.6 vs. 0.4%, P = 0.09 and 0.09).ConclusionBivalirudin, started during transport for primary PCI, reduces major bleeding compared with both patients treated with heparin only plus bailout GPI and patients treated with heparin and routine GPI, but increased stent thrombosis.
ACCA study group on pre-hospital care.
AbstractChest pain and acute dyspnoea are frequent causes of emergency medical services activation. The pre-hospital management of these conditions is heterogeneous across different regions of the world and Europe, as a consequence of the variety of emergency medical services and absence of specific practical guidelines. This position paper focuses on the practical aspects of the pre-hospital treatment on board and transfer of patients taken in charge by emergency medical services for chest pain and dyspnoea of suspected cardiac aetiology after the initial assessment and diagnostic work-up. The objective of the paper is to provide guidance, based on evidence, where available, or on experts' opinions, for all emergency medical services' health providers involved in the pre-hospital management of acute cardiovascular care.
key-words: ST elevation myocardial infarction -acute coronary syndromes -acute cardiac carepre-hospital -emergency medical service -networks 2
IntroductionOptimal treatment for ST-elevation myocardial infarction (STEMI) is based on a reperfusion strategy employing either primary percutaneous coronary intervention (PPCI) or thrombolytic therapy (TT). A sizable proportion of STEMI patients are not reperfused, time delays are frequently unacceptable 1 and very few patients receive all the guideline-recommended therapies in a timely manner. Decision-making in the pre-hospital setting is pivotal for optimal STEMI care, and delays in therapy cannot later be compensated.Thus, the empowerment of paramedical staff is key to successful pre-hospital STEMI management. This requires the implementation of systems of care (STEMI networks), in which the Emergency Medical Service (EMS), non-PCI-capable hospitals, and hospitals with PCI facilities cooperate closely in order to reduce the total ischaemic time, increase the number of patients receiving reperfusion therapy, and to reduce heart failure and mortality 2 .
DelaysThe total ischaemic time ( Figure 1) is often unacceptably long with only 11-15% patients treated within the recommended time intervals.
3Patient delay. An early first call to the EMS is desirable as rapid diagnosis and treatment at the scene has been shown to save lives and prevent complications. The patient's decision time (PDT) has historically remained constant at between 1-3 hours. Patients with longer PDTs tend to be older, female and diabetic, with atypical symptoms. There is significant variation in the use of EMS in STEMI (28-82% patients) and in the PDTs (81-174 mins) throughout Europe. While several public initiatives have been successful in shortening PDTs, such campaigns have only a temporary impact.An integral part of the EMS is triage by the emergency medical dispatcher. First medical contact is defined as the time at which STEMI diagnosis is made using ECG, irrespective of the setting.Pre-hospital organisation. Not all patients referred for PPCI receive optimal percutaneous reperfusion (i.e.PCI performed in a timely manner by an experienced team), and even in urban locations a minority still require pre-hospital thrombolysis (PH-T) 4 . Geographical considerations and distribution of PPCI centres are two factors that contribute to the variability in European rates (5-92%). 5 The best evidence for reperfusion 3 strategies is based on in-hospital STEMI studies, and more high-quality research on the pre-hospital environment is needed. The key to diagnosis is the pre-hospital electrocardiogram (PH-ECG) 6 , interpreted on site and/or transmitted for interpretation
Pre-hospital ECGThe use of the PH-ECG is widespread in some countries and has been shown to reduce the time to reperfusion and mortality in patients with STEMI. Trained paramedics can identify STEMI with a good sensitivity and specificity, with multiple studies demonstrating that PH-ECGs decrease door-to-needle (D2N) and door-to-balloon (D2B)...
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