Dataset Information

Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study).

ABSTRACT: Delayed onset of action of oral P2Y12 inhibitors in ST-elevation myocardial infarction (STEMI) patients may increase the risk of acute stent thrombosis. Available parenteral anti-thrombotic strategies, to deal with this issue, are limited by added cost and increased risk of bleeding. We investigated the pharmacodynamic effects of a novel regimen of enoxaparin in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). Twenty patients were recruited to receive 0.75 mg/kg bolus of enoxaparin (pre-PPCI) followed by infusion of enoxaparin 0.75 mg/kg/6 h. At four time points (pre-anti-coagulation, end of PPCI, 2-3 hours into infusion and at the end of infusion), anti-Xa levels were determined using chromogenic assays, fibrin clots were assessed by turbidimetric analysis and platelet P2Y12 inhibition was determined by VerifyNow P2Y12 assay. Clinical outcomes were determined 14 hours after enoxaparin initiation. Nineteen of 20 patients completed the enoxaparin regimen; one patient, who developed no-reflow phenomenon, was switched to tirofiban after the enoxaparin bolus. All received ticagrelor 180?mg before angiography. Mean (±?standard error of the mean) anti-Xa levels were sustained during enoxaparin infusion (1.17?±?0.06 IU/mL at the end of PPCI and 1.003?±?0.06 IU/mL at 6 hours), resulting in prolonged fibrin clot lag time and increased lysis potential. Onset of platelet P2Y12 inhibition was delayed in opiate-treated patients. No patients had thrombotic or bleeding complications. In conclusion, enoxaparin 0.75 mg/kg bolus followed by 0.75 mg/kg/6 h provides sustained anti-Xa levels in PPCI patients. This may protect from acute stent thrombosis in opiate-treated PPCI patients who frequently have delayed onset of oral P2Y12 inhibition.

SUBMITTER: Sumaya W

PROVIDER: S-EPMC6202933 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study).

Sumaya Wael W Parker William A E WAE Fretwell Rebekah R Hall Ian R IR Barmby David S DS Richardson James D JD Iqbal Javaid J Adam Zulfiquar Z Morgan Kenneth P KP Gunn Julian P JP Mason Annah E AE Judge Heather M HM Gale Christopher P CP Ajjan Ramzi A RA Storey Robert F RF

Thrombosis and haemostasis 20180606 7

Delayed onset of action of oral P2Y<sub>12</sub> inhibitors in ST-elevation myocardial infarction (STEMI) patients may increase the risk of acute stent thrombosis. Available parenteral anti-thrombotic strategies, to deal with this issue, are limited by added cost and increased risk of bleeding. We investigated the pharmacodynamic effects of a novel regimen of enoxaparin in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). Twenty patients were recruited to receive 0.75 ...[more]

PMID: 29874689

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Project description:BackgroundPercutaneous coronary intervention (PCI) has been shown to improve health-related quality of life (HRQoL) in patients with coronary artery disease (CAD). The objectives of this study were to assess the changes in HRQoL and factors influencing these changes in CAD patients after undergoing PCI.MethodsData from a nationwide PCI registry across 39 hospitals in Thailand were collected in 2018-2019, including baseline characteristics, comorbid diseases, angiographic CAD severity, procedural details, and type of health insurance. HRQoL, as measured by utility scores, was determined in all patients using the Thai version of EQ-5D-5l at admission, discharge, and 6 and 12 months after discharge. The effects of time after PCI procedure and various factors on mean utility scores were assessed using a mixed-effect linear regression model.ResultsA total of 19,701 patients were included in the analysis; they had a mean age of 64.2 ± 11.7 years and were predominantly (69.1%) male. Following PCI, the mean utility scores increased from 66.6 ± 19.6 at admission to 81.9 ± 13.8 at discharge, and remained stable at 6 and 12 months (86.1 ± 12.3 and 88.0 ± 11.7, respectively). After adjusting for potential confounding variables, several factors were found to be independently associated with improved HRQoL, including angiographic success, male gender, overweight status, dyslipidemia, and radial access. Six other factors were associated with less improved HRQoLs, including cardiogenic shock/IABP support, old age, CKD, clinical presentation (STEMI and NSTEMI), prior cerebrovascular disease, and heart failure. There were no associations of CAD severity and procedural details with HRQoL. No differences were found related to type of health insurance, except that patients who were uninsured or self-pay tended to have less improvement in HRQoL.ConclusionHRQoL improved significantly after PCI in these subjects, as observed through 1 year of follow-up. Identifying the factors influencing these improvements may assist clinicians in tailoring patient interventions to optimise quality of life after PCI.

Project description:ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008 consecutive PCI patients with stent implantation, without exclusion criteria.InterventionPeri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (≥50 U) and arachidonic acid (AA)-induced aggregation (>35 U).Outcome measuresThe primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE).Results53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both).ConclusionsIndividualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted.Trial registration numberhttp://www.clinicaltrials.gov; NCT01515345.

Dataset Information

Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study).

Publications

Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study).

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