10 research outputs found

    Determinants of clinical outcomes following primary percutaneous coronary intervention: the West Yorkshire Primary Percutaneous Coronary Intervention Outcome Study

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    Objectives: To identify determinants of clinical outcomes following primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI). Background: Although PPCI is currently the gold-standard guideline-indicated care for STEMI in the UK, factors associated with important clinical outcomes are still being explored and discovered. The purpose of this study and the analyses within this study, is to identify factors that were either previously unreported or variably reported. Methods: Baseline and procedural data of all consecutive patients undergoing PPCI between 01-01-2009 and 31-12-2011, and between 01-01-2013 and 31-12-2013 in Leeds General Infirmary UK were collected prospectively in the West Yorkshire Primary Percutaneous Coronary Intervention (WY-PPCI) research and audit databases. Patients were followed up to a minimum of 12-months following index-PPCI. Five analyses were undertaken to assess the association between the following factors and clinical outcomes in PPCI: gender, ethnicity, P2Y12-receptor inhibitor, individual operator PPCI volume, glycoprotein IIb/IIIa inhibitor (GPI) use according to arterial access site. Multivariable analysis was undertaken to adjust for potential confounders. Clinical endpoints (depending on analyses) were: major adverse cardiovascular events (MACE; defined as all-cause mortality, myocardial infarction (MI), and repeat target and non-target vessel revascularisation), and HORIZONS-major bleeding. Results: Gender: Although women were older than men at presentation (median age 69 vs 60yr, p <0.01), mortality and MACE were not statistically significantly higher in women after stratification into age groups (<60, 60-79, and ≥80yr) alone, and also after multivariable analysis. Age was most strongly associated with adverse outcomes. Ethnicity: Univariable and multivariable analysis both revealed no significant differences in MACE and mortality between South Asian and White patients, despite South Asian patients being significantly younger than White patients. P2Y12-receptor inhibitor therapy: After multivariable analysis, both ticagrelor and prasugrel were associated with lower recurrent MI compared to clopidogrel. However, only prasugrel was associated with reduced mortality, both in comparison with clopidogrel and ticagrelor. There was no difference in bleeding between the three drugs. Annual operator PPCI volume: Low annual operator-volume (<55 PPCI cases per year) was independently associated with 30-day mortality compared to high operator-volume (≥110 PPCI per year), suggesting a volume-outcome relationship at a significantly higher threshold than the AHA/ACC/SCAI recommendation of ≥11 PPCI cases per year. GPI-use: In transfemoral PPCI, GPI use was independently associated with higher 30-day bleeding (particularly access-site bleeding) and mortality compared to no GPI-use. In transradial PPCI, GPI use was not associated with increased bleeding or mortality. Conclusion This study has identified important factors associated with outcomes following in the real-world, in a large, contemporary “all-comers” registry. Analyses from this study should lead to the interrogation of larger databases and possibly changes in guideline recommendations

    New environments for neurophysiological investigations.

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    The main topics of research are in the sub-areas of neurophysiology that are concerned with measurement of the electrical activity arising from contracting muscle (EMG) and from the surface of the scalp (EEG). Investigations are restricted to the surface-recorded interference pattern EMG, and to the EEG waveform recorded in response to sensory stimulation, known as the evoked potential (EP). The EMG and EP are representative of two important classes of signal commonly encountered in engineering, namely random noise-like and deterministic non-stationary. The thesis describes work on the development of a variety of new techniques and methods of analysis for application in neurophysiology and electrodiagnosis. A general purpose signal processing computer has been built which incorporates a high level of user-machine ergonomics. Turning Points Spectral estimation of the interference pattern EMG is simulated on this computer to demonstrate its flexibility for constructing analysis and control applications. Some emphasis is placed on methods of improving the quality of acquired EMG data for use in the analysis of the dynamics of the neuromuscular system. In this respect, the author describes the design of a fully controllable muscle loading system which uses dc electromagnetic suspension technology. The above computer can be used to control this muscle load for accurate loading protocols in EMG-Force modelling experiments. Techniques involved in the design and construction of the computer lead to higher-level program and data analysis specifications which employ Artificial Intelligence (AI) computing methods. These AI methods, in conjunction with some of those techniques which were used for EMG analysis, are applied to the investigation of single-trial EPs. A suite of adaptive EP analysis procedures, which include a prototype fuzzy expert system, facilitate the extraction of EP component latency variability estimates, and also provide automatic selective single-trial averaging. The latter selective averaging facility, can be used to enhance underlying activity and to examine the relationships that might exist between different components in the EP

    Clinical outcomes following primary percutaneous coronary intervention for ST-elevation myocardial infarction according to sex and race

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    Background: Female sex and South Asian race have been associated with poor clinical outcomes following primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) but remain understudied in large real-world series. We therefore investigated the association of sex and race with clinical outcomes following PPCI. Methods: We conducted a prospective study of all patients undergoing PPCI for STEMI between January 2009 and December 2011 at a large UK cardiac centre. Clinical characteristics and outcomes were compared according to sex and race using Chi-square test, independent samples Student’s t-test and Mann–Whitney U-test. Primary and secondary outcomes were 12-month major adverse cardiovascular events (MACEs) – defined as all-cause mortality, myocardial infarction and unplanned revascularization, analysed using Cox proportional hazard models adjusting for cardiovascular risk factors. Results: Three thousand and forty-nine patients were included. Women (n=826) were older than men (n=2223) (median age 69 vs. 60 years, p <0.01). Mortality (hazard ratio 1.48 (1.15–1.90)) and MACE (hazard ratio 1.40 (1.14–1.72)) were higher in women in univariable analysis. However, there were no significant sex-differences in mortality or MACE after age-stratification alone. Multivariable analysis also showed no significant differences in outcomes between sexes. South Asians (n=297) were younger but had a higher prevalence of most risk factors than White patients (n=2570). Mortality and MACE did not differ significantly between South Asian and White patients in univariable or multivariable analysis. Conclusion: MACE and mortality was not greater in women, or in South Asian patients following PPCI after adjustment for cardiovascular risk factors including age, which was most strongly associated with both outcomes

    Real-world comparison of clopidogrel, prasugrel and ticagrelor in patients undergoing primary percutaneous coronary intervention

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    Background There is a paucity of real-world outcome data comparing clopidogrel, prasugrel and ticagrelor in primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI). We sought to assess the association of choice of oral P2Y12-receptor inhibitor with clinical outcomes following PPCI for STEMI in a large consecutive patient series. Methods Demographic, procedural and 12-month outcome data were prospectively collected for all patients undergoing PPCI in Leeds, UK, between 01 January 2009 and 31 December 2011, and 01 January 2013 and 31 December 2013. Clinical endpoints were 30-day and 12-month all-cause mortality, recurrent MI and 30-day HORIZONS-major bleeding. Logistic regression analyses were undertaken to adjust for confounding factors. Results Prasugrel (n=1244) was associated with lower adjusted 30-day (OR 0.53 (0.34–0.85)) and 12-month (OR 0.55 (0.38–0.78)) mortality, and 12-month MI (OR 0.63 (0.42–0.94)) compared with clopidogrel (n=1648). Importantly, prasugrel was associated with lower adjusted 30-day mortality (OR 0.51 (0.29–0.91)) compared with ticagrelor (n=811). Lower 30-day (OR 0.40 (0.17–0.94)) and 12-month (OR 0.54 (0.32–0.93)) MI were observed in ticagrelor compared with clopidogrel, an association absent in comparison with prasugrel. Adjusted bleeding were not statistically significantly different among the P2Y12-receptor inhibitors. Conclusion In this large consecutive real-world series, prasugrel was associated with lower adjusted 30-day mortality compared with ticagrelor and clopidogrel, and lower adjusted 12-month mortality compared with clopidogrel. Both prasugrel and ticagrelor were associated with lower recurrent MI following PPCI compared with clopidogrel, with no overall increase in adjusted bleeding

    Association between operator volume and mortality in primary percutaneous coronary intervention

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    Background There is a paucity of real-world data assessing the association of operator volumes and mortality specific to primary percutaneous coronary intervention (PPCI). Methods Demographic, clinical and outcome data for all patients undergoing PPCI in Leeds General Infirmary, UK, between 1 January 2009 and 31 December 2011, and 1 January 2013 and 31 December 2013, were obtained prospectively. Operator volumes were analysed according to annual operator PPCI volume (low volume: 1–54 PPCI per year; intermediate volume: 55–109 PPCI per year; high volume: ≥110 PPCI per year). Cox proportional hazards regression analyses were undertaken to investigate 30-day and 12-month all-cause mortality, adjusting for confounding factors. Results During this period, 4056 patients underwent PPCI, 3703 (91.3%) of whom were followed up for a minimum of 12 months. PPCI by low-volume operators was associated with significantly higher adjusted 30-day mortality (HR 1.48 (95% CI 1.05 to 2.08); p=0.02) compared with PPCI performed by high-volume operators, with no significant difference in adjusted 12-month mortality (HR 1.26 (95% CI 0.96 to 1.65); p=0.09). Comparisons between low-volume and intermediate-volume operators, and between intermediate and high-volume operators, showed no significant differences in 30-day and 12-month mortality. Conclusions Low operator volume is independently associated with higher probability of 30-day mortality compared with high operator volume, suggesting a volume–outcome relationship in PPCI at a threshold higher than current recommendations

    Mineralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-elevation myocardial infarction (the MINIMISE STEMI Trial): rationale and study design.

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    Novel therapies capable of reducing myocardial infarct (MI) size when administered prior to reperfusion are required to prevent the onset of heart failure in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). Experimental animal studies have demonstrated that mineralocorticoid receptor antagonist (MRA) therapy administered prior to reperfusion can reduce MI size, and MRA therapy prevents adverse left ventricular (LV) remodeling in post-MI patients with LV impairment. With these 2 benefits in mind, we hypothesize that initiating MRA therapy prior to PPCI, followed by 3 months of oral MRA therapy, will reduce MI size and prevent adverse LV remodeling in STEMI patients. The MINIMISE-STEMI trial is a prospective, randomized, double-blind, placebo-controlled trial that will recruit 150 STEMI patients from four centers in the United Kingdom. Patients will be randomized to receive either an intravenous bolus of MRA therapy (potassium canrenoate 200 mg) or matching placebo prior to PPCI, followed by oral spironolactone 50 mg once daily or matching placebo for 3 months. A cardiac magnetic resonance imaging scan will be performed within 1 week of PPCI and repeated at 3 months to assess MI size and LV remodeling. Enzymatic MI size will be estimated by the 48-hour area-under-the-curve serum cardiac enzymes. The primary endpoint of the study will be MI size on the 3-month cardiac magnetic resonance imaging scan. The MINIMISE STEMI trial will investigate whether early MRA therapy, initiated prior to reperfusion, can reduce MI size and prevent adverse post-MI LV remodeling

    Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

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    BACKGROUND: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. METHODS: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. FINDINGS: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. INTERPRETATION: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. FUNDING: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden
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