BackgroundThere is a paucity of data regarding clinical outcomes associated with the integration of a mild therapeutic hypothermia (MTH) protocol into a regional network dedicated to treatment of patients with acute coronary syndromes (ACS). Additionally, a recent report suggests that the neurological benefits of MTH therapy in interventionally managed ACS patients resuscitated from out-of-hospital cardiac arrest (OHCA) may be potentially offset by the catastrophic occurrence of stent thrombosis. The goal of this study was to share our experience with the implementation of an MTH program using a previously established ACS network in consecutive comatose OHCA survivors undergoing interventional management due to an initial diagnosis of ACS and to assess the clinical effectiveness and safety of MTH.MethodsWe conducted a retrospective historically controlled single centre study. Hospital survival with a favourable neurological outcome (Cerebral Performance Category of 1 or 2) and all-cause in-hospital mortality were the primary and secondary efficacy end points, respectively. Occurrence of definite stent thrombosis was the primary safety end point while the development of pneumonia, presence of positive blood cultures, occurrence of probable stent thrombosis, any bleeding complications, need for red blood cell transfusion and presence of rhythm and conductions disorders during hospitalisation constituted secondary safety end points.ResultsComatose OHCA survivors (n = 32) were referred to our Department based on ECG recording transmissions and/or phone consultations or admitted from the Emergency Department. Compared with controls (n = 33), they were significantly more likely to be discharged from hospital with a favourable neurological outcome (59 vs. 27%; p < 0.05; number needed to treat [NNT] = 3.11) and experienced lower all-cause in-hospital mortality (13 vs. 55%; p < 0.05; NNT = 2.38). Rates of all safety end points were similar in patients treated with and without MTH.ConclusionsOur study indicates that a regional system of care for OHCA survivors may be successfully implemented based on an ACS network, leading to an improvement in neurological status and to a reduction of in-hospital mortality in patients treated with MTH, without any excess of complications. However, our findings should be verified in large, prospective trials.
Extensive search for methods of overcoming morphine-related delay of the absorption and onset of action of oral P2Y12 inhibitors in patients presenting with acute coronary syndrome is on-going. The aim of the trial was to investigate whether metoclopramide co-administration could reduce this delay and improve the pharmacokinetics (PKs) and pharmacodynamics (PDs) of ticagrelor and its active metabolite AR-C124900XX. Plasma concentration of both compounds and platelet reactivity were evaluated in nine pre-defined time points within 6 hours after administration of ticagrelor loading dose. The results of our study show that mean platelet activity within the first hour was noticeably higher in metoclopramide-naive patients. Moreover, ticagrelor mean plasma concentration was significantly higher within the initial four time points (15, 30, 45, 60 minutes) in patients receiving metoclopramide (p = 0.039; p = 0.009; p = 0.005; p = 0.008, respectively). To conclude, the co-administration of metoclopramide in patients presenting with unstable angina and treated with morphine, has a beneficial effect on the PK/PD profile of ticagrelor and its metabolite; however, its impact on ST-elevation myocardial infarction patients requires further investigation.
Mild therapeutic hypothermia for patients with acute coronary syndrome and cardiac arrest treated with percutaneous coronary intervention (UNICORN). The design and rationale for the prospective, observational, multicenter study Methods. The UNICORN study is a phase IV, prospective, international, multi-centre, observational study designed to assess the effectiveness of MTH in patients after OHCA with shockable rhythm presenting with acute coronary syndrome (ACS). The trial is expected to include up to 500 patients. Depending on the availability of MTH in each study centre, besides the routine treatment of ACS in OHCA survivors, patients will either undergo MTH according to a uniform protocol or will not undergo MTH (250 patients per group). The primary end-point of the study is all cause mortality at 180 days after enrolment. Secondary end-points include: neurological outcome at discharge, stent thrombosis at 30 days, bleeding according to the BARC criteria, infectious complications at 180 days, and rhythm and conduction disorders at 180 days.Ethics and dissemination. The study received approval from the Local Ethics Committee to conduct the study (Komisja Bioetyczna Uniwersytetu Mikołaja Kopernika w Toruniu przy Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy; study approval reference number KB 615/2015). The study results will be disseminated through conference presentations and publications in peer-reviewed journals.Trial registration. ClinicalTrials.gov identifier: NCT02611934 (18 November 2015).
Background: Mild therapeutic hypothermia (MTH) is a recommended treatment of comatose patients after out-of-hospital cardiac arrest (OHCA). The aim of the study was to examine determinants of clinical outcome in OHCA survivors treated with MTH and variables associated with MTH induction time. Methods: Presented herein is an analysis of combined results from a retrospective and a prospective observational study which included 90 OHCA survivors treated with MTH from January 2010 to March 2018. Multivariate regression analysis was performed to determine variables associated with poor neurologic outcome (Cerebral Performance Category 3-5), mortality, and prolonged induction time. Results: At hospital discharge, 59 (65.6%) patients were alive, of whom 36 (61%) had a good neurologic outcome. Older patients (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.03-1.12) with lower Glasgow Coma Scale (GCS) (OR 0.49, were at higher risk of poor neurological outcome. The predictors of in-hospital death included: older age (OR 1.08, 95% CI 1.02-1.13), lower GCS score (OR 0.47, 95% CI 0.25-0.85), presence of cardiogenic shock (OR 3.43,, and higher doses of adrenaline (OR 1.27,. Longer induction was associated with shorter cardio-pulmonary resuscitation (CPR) (unstandardized coefficient -3.95, 95% CI -7.09 to -0.81) and lower lactate level ). Conclusions: Unfavorable neurologic outcome in OHCA patients treated with MTH is associated with age and lower GCS score. Risk factors for in-hospital mortality include age, high-dose adrenaline administration, lower GCS score and presence of cardiogenic shock. CPR duration and lactate level were predictive of prolonged MTH induction time. (Cardiol J XXXX; XX, X: xx-xx) Key words: mild therapeutic hypothermia, targeted temperature management, out-of-hospital cardiac arrest 1 www.cardiologyjournal.org INTERVENTIONAL CARDIOLOGY
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