Tag Archives: acute coronary syndrome

Drug-to-drug interaction. New evidences on Morphine and delayed onset of action of antiplatelet agents.

8 Mag

A recently published article entitled  “Chest pain relief in patients with acute myocardial infarction” (European Heart Journal: Acute Cardiovascular Care April 22, 2015) address in a very well documentrd way the topic about drug-to-drug interactiono between morfine and antiplatelets agents in STEMI patients.

Guido Parodi, a lead interventional cardiologist in Cardiovascular and Thoracic Department of Careggi Hospital in Florence, (Italy) author of the article, highlights the fact that “despite the complete absence of rigorous studies designed to assess the impact of morphine administration in patients with AMI, clinical practice guidelines for the management of patients with STEMI strongly recommend the use of morphine for analgesia.”

As indicated in the article recent literature indicates an increased risk of mortality in STEMI patients treated with Morphine.

The analysis of CRUSADE registry in 2005 has shown how patients treated with morphine had a higher adjusted risk of death than patients not treated with morphine even after using a propensity score matching method. This is a non randomized trial and so influenced from potential bias, and the hypothesis that morphine was administered to higher-risk patients is also to be considered. But an additional potential explanation of morphine’s negative impact on AMI outcome may be related to drug-to-drug interactions.

Biologically a cause effect relation can be explained, because morphine inhibits gastric emptying, delaying absorption and so decreasing peak plasma levels of orally administered drugs in general and antiplatelet agents in this particular case.
This was very well demonstrated in a 2015 study from the same author “Morphine is associated with a delayed activity of oral antiplatelet agents in patients with ST elevation acute myocardial infarction undergoing primary PCI” (Parodi G, Bellandi B, Xanthopoulou I, et al. Circ Cardiovasc Interv Epub ahead of print January 2015) in whom the negative impact of morphine on platelet inhibition was not only limited to patients who vomited (patients with vomiting were excluded), but morphine-treated patients clearly showed higher residual platelet reactivity compared with patients who did not receive morphine.

In ATLANTIC Trial (Montalescot G, van ‘t Hof AW, Lapostolle F, et al.; ATLANTIC Investigators. Prehospital ticagrelor in ST-elevation myocardial infarction. New Engl J Med 2014; 371: 1016–1027), STEMI patients who did not receive morphine had a significant improvement in the ECG-based primary end point (ST-segment resolution), reflecting better myocardial reperfusion,with a significant “p” value for interaction between morphine use and time of ticagrelor administration. Professor Montalescot one of the lead authors of this Trial noted:“Co-administration of morphine in the ambulance may have delayed ticagrelor’s onset of action. To what extent this interaction may have affected our results remains unknown at this stage.”

So what to do with analgesia strategy in STEMI patients?

Given the key importance of platelet inhibition in patients treated by PPCI for STEMI and the absence of data that may support a potential clinical benefit of morphine in patients with acute myocardial infarction, more caution should be used regarding morphine administration in STEMI patients, and a restricted morphine use seems to be reasonably recommended.

Morphine administration has to be reserved, as suggested in the article, just for level of pain ≥ 7 on the base of a numerical rating scale (NRS) related value.

Courtesely from Dott. Guido Parodi

Courtesely from Dott. Guido Parodi

For lower chest pain intensity (NRS ≤ 7) alternative strategies has to be persecuted.
The author indicates paracetamol (1 g) or aspirin (≥300 mg) as alternative of choice to reduce chest pain as well demonstrated in letterature.
It has also to be considered how first line agents, currently indicated from STEMI guidelines, as Beta- blocker and Nitrates are able to reduce AMI-related chest pain until the definitive pain relief effect obtained with myocardial mechanical reperfusion.

Bottom Line

The first impact to reduce chest pain has to be reserved to Nitrates or B-blockers (where all contraindications are excluded).

After this NRS has to be evaluated and the use of Morphine is indicated only for values above 7. For lower values Paracetamol or Aspirin are the agents of choice.

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References

  • Parodi G. Chest pain relief in patients with acute myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2015 Apr 22. pii: 2048872615584078. [Epub ahead of print] Review.PMID:25904757

  • Meine TJ, Roe MT, Chen AY, et al. Association of intravenous morphine use and outcomes in acute coronary syndromes: Results from the CRUSADE Quality Improvement Initiative. Am Heart J 2005; 149: 1043–1049.

  • Parodi G,Valenti R, Bellandi B, et al. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation
    myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol 2013; 61: 1601–1606
  • Parodi G, Bellandi B, Valenti R, et al. Comparison of double (360 mg) ticagrelor loading dose with standard (60 mg) prasugrel loading dose in STEMI patients: The Rapid Activity of Platelet Inhibitor Drugs (RAPID) primary PCI 2 study.
    Am Heart J 2014; 167: 909–914.
  • Nimmo WS, Heading RC, Wilson J, et al. Inhibition of gastric emptying and drug absorption by narcotic analgesics. Br J Clin Pharmacol 1975; 2: 509–513.
  • Parodi G, Xanthopoulou I, Bellandi B, et al. Ticagrelor crushed tablets administration in STEMI patients: The MOJITO study. J Am Coll Cardiol 2015; 65: 511–512.
  • Montalescot G, van ‘t Hof AW, Lapostolle F, et al.; ATLANTIC Investigators. Prehospital ticagrelor in ST-elevation myocardial infarction. New Engl J Med 2014; 371: 1016–1027
  • Duggan ST and Scott LJ. Intravenous paracetamol (acetaminophen). Drugs 2009; 69: 101–113.
  • Zijlstra F, Ernst N, de Boer MJ, et al. Influence of prehospital administration of aspirin and heparin on initial patency of
    the infarct-related artery in patients with acute ST elevation myocardial infarction. J Am Coll Cardiol 2002; 39: 1733–1737
  • Yusuf S, Sleigh P, Rossi P, et al. Reduction in infarct size and chest pain by early intravenous beta blockade in suspected
    acute myocardial infarction. Circulation 1983; 67: 132–141.
  • Kim YI and Williams JF Jr. Large dose sublingual nitroglycerin in acute myocardial infarction: Relief of chest pain and reduction of Q wave evolution. Am J Cardiol 1982; 49: 842–848.

Morphine and antiplatelet therapies in acute myocardial infarction: a possible interaction

20 Set

We publish this contribute from Dott. Guido Parodi.

Guido is a good friend of MEDEST and an exceptional interventional cardiologist working at Careggi Hospital in Florence.

The passion for medical research made Guido one of the lead investigators in many studies about antiplatelets therapies in acute coronary syndromes.

His enthusiastic way to work and to talk about the things he does is contagious. So we had this wonderful connection from the first time we met many years ago.

In this post he talks about a brilliant intuition he had, on the possible drug-to-drug interaction between morphine and antiplatelets agents.

So let’s go to the post.

Introduction

Antiplatelet agents are the mainstay of pharmacological treatment in patients presenting with an acute coronary syndrome, including STEMI. Currently, new strategies are under investigation to improve antithrombotic treatment in patients with ST-elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PPCI). Prasugrel and Ticagrelor, the newer, potent, fast and effective platelet P2Y12 receptor inhibitors, are recommended for STEMI patients in the European Guidelines (1) with the highest level of recommendation (I) and evidence (A).

Drug-to-drug interaction: RAPID and ATLANTIC study

In patients with STEMI undergoing PPCI a significant number of drugs are usually administered, thereby raising the potential risk for drug-to-drug interaction. In a recent small randomized study aimed to investigate the onset time of the novel P2Y12 receptor inhibitors (i.e., prasugrel and ticagrelor) in STEMI, a delayed antiplatelet effect due to morphine use in the first hours of STEMI has been hypothesized (2). This study showed that residual platelet reactivity soon after a loading dose of prasugrel and ticagrelor in patients with STEMI is higher than that reported for healthy volunteers or subjects with stable coronary artery disease and the majority of PPCI procedures with stent implantation are performed without proper platelet inhibition. A several hours vulnerable window of suboptimal antithrombotic therapy exists, in which STEMI patients are at high risk of thrombotic events, including stent thrombosis. Moreover, in this study morphine use resulted to be associated with a delayed activity of the new oral antiplatelet agents. There may be a biologically plausible cause-effect-relation in this association, given that morphine inhibits gastric emptying, thereby delaying absorption and possibly resulting in decreased peak plasma levels of orally administered drugs. Recently, an international multicentre randomized study, the ATLANTIC trial (3), showed that the pre-hospital administration of the potent platelet P2Y12-receptor antagonist ticagrelor shortly before PPCI in patients with STEMI appeared to be safe but did not improve reperfusion of the culprit artery. Interestingly, the ATLANTIC trial showed that the primary end point of ST-segment resolution was significantly improved with pre-hospital administration of ticagrelor in patients not receiving morphine (P = 0.005) for interaction supporting the hypothesis of a drug-to-drug interaction between morphine and oral antiplatelet agents.

Bottom line

Given the key importance of platelet inhibition in patients treated by PPCI for STEMI and the absence of data that may support a potential clinical benefit of morphine in patients with acute myocardial infarction, more caution should be used regarding morphine administration in STEMI patients, and a restricted morphine use seems to be reasonably recommended.
Courtesely from Dott. Guido Parodi

Courtesely from Dott. Guido Parodi

References

Logo MEDEST2

ACCOAST Trial failed primary end points. Still lack of evidence on benefits of antiplatelets pretreatment in ACS patients undergoing PCI

22 Gen

ACCOAST: Pretreatment with Prasugrel in Non–ST-Segment Elevation Acute Coronary Syndromes

Among patients with NSTE acute coronary syndromes who were
scheduled to undergo catheterization,
pretreatment with prasugrel did not reduce
the rate of major ischemic events up to 30 days
but increased the rate of major bleeding complications.”
  The New England Journal of Medicine vol. 369 no. 11

Il falllimento di ACCOAST pone nuovi e seri interrogativi su quella che è una pratica largamente diffusa nel trattamento di pazienti con sindrome coronarica acuta. Già in passato avevamo posto il probelma riguardo al pretrattamento con antiaggreganti piastrinici (Clopidogrel), il cui beneficio sulla mortalità era stato messo fortemente in dubbio da una review sistematica pubblicata sul JAMA nel 2012 (Association of Clopidogrel Pretreatment With Mortality, Cardiovascular Events, and Major Bleeding Among Patients Undergoing Percutaneous Coronary Intervention).

Anche il Ticagrelor del resto non sta navigando in acque tranquille (vedi La travagliata storia del Ticagrelor) visti i dubbi che riguardano i trial effettuati e le richieste d’approfondimento della FDA sfociate enll’esecuzione di un nuovo studio “riparatore” i cui risultati non sono ancora disponibili.

Inoltre, come già accennato con Guido Parodi, autore dello studio RAPID (Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID Rapid Activity of Platelet Inhibitor Drugs primary PCI study), gli antiaggreganti piastrinici utilizzati in pretrattamento, poco giustificano il loro impiego, in contesti in cui i tempi tra “first medical contact” e “baoloon” sono brevi, vista la lunga latenza dell’attivita inibitoria piastrinica.

Bottom Line

Alla luce delle evidenze attuali e viste le caratteristiche intrinseche dei farmaci disponibili, l’utilizzo degli antiaggreganti piastrinici nel pretrattamento dei pazienti con SCA che effettuano la PCI non è indicato.

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RAPID: Ticagrelor e Copidogrel a confronto nel paziente con STEMI.

8 Ago

Comparison of Prasugrel and Ticagrelor Loading Doses in ST-Segment Elevation Myocardial Infarction Patients

RAPID (Rapid Activity of Platelet Inhibitor Drugs) Primary PCI Study

Guido Parodi, MD, PHD, Renato Valenti, MD, Benedetta Bellandi, MD, Angela Migliorini, MD, Rossella Marcucci, MD, Vincenzo Comito, MD, Nazario Carrabba, MD, Alberto Santini, MD, Gian Franco Gensini, MD, Rosanna Abbate, MD, David Antoniucci, MD Florence, Italy

OBJECTIVES: This study sought to compare the action of prasugrel and ticagrelor in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI). BACKGROUND: It has been documented that prasugrel and ticagrelor are able to provide effective platelet inhibition 2 h after a loading dose (LD). However, the pharmacodynamic measurements after prasugrel and ticagrelor LD have been provided by assessing only healthy volunteers or subjects with stable coronary artery disease. METHODS: Fifty patients with STEMI undergoing PPCI with bivalirudin monotherapy were randomized to receive 60 mg prasugrel LD (n = 25) or 180 mg ticagrelor LD (n = 25). Residual platelet reactivity was assessed by VerifyNow at baseline and 2, 4, 8, and 12 h after LD. RESULTS: Platelet reactivity units (PRU) 2 h after the LD (study primary endpoint) were 217 (12 to 279) and 275 (88 to 305) in the prasugrel and ticagrelor groups, respectively (p = NS), satisfying pre-specified noninferiority criteria. High residual platelet reactivity (HRPR) (PRU ≥240) was found in 44%and 60% of patients (p = 0.258) at 2 h. The mean time to achieve a PRU <240 was 3 ± 2 h and 5 ± 4 h in the prasugrel and ticagrelor groups, respectively. The independent predictors of HRPR at 2 h were morphine use (odds ratio: 5.29; 95% confidence interval: 1.44 to 19.49; p = 0.012) and baseline PRU value (odds ratio: 1.014; 95% confidence interval: 1.00 to 1.03; p = 0.046). CONCLUSIONS: In patients with STEMI, prasugrel showed to be noninferior as compared with ticagrelor in terms of residual platelet reactivity 2 h after the LD. The 2 drugs provide an effective platelet inhibition 2 h after the LD in only a half of patients, and at least 4 h are required to achieve an effective platelet inhibition in the majority of patients. Morphine use is associated with a delayed activity of these agents. (Rapid Activity of Platelet Inhibitor Drugs Study, NCT01510171).

Abbiamo parlato con uno degli autori del lavoro: Guido Parodi, cardiologo interventista della Dipartimento del cuore e dei vasi al Policlinico Ospedaliero Universitario di Careggi a Firenze.

Logo MEDEST2Guido buongiorno e grazie di aver accettato il nostro invito

Buongiorno a tutti

Logo MEDEST2Quali sono le implicazioni  del vostro sudio per l’emergenza sanitaria preospedaliera.

Sicuramente la somministrazione dell’antiaggregante precocemente sul territorio ha un benefit sia in termini di flusso Timi all’arrivo in sala di emodinamica che di re-stenosi e di mortalità sul paziete con STEMI che viene sottoposto a PCI.

 Logo MEDEST2Quindi l’ASA somministrata dal medico d’emergenza a casa del paziente è ancora un cardine nella terapia dello STEMI

Direi di si, anzi i dati evidenziano una tendenziale preferenza per dosaggi alti e via di somministrazione rapida (Aceltisalicilato di Lisina ev ndr) come opzione migliore sull’inibizione della catena dell’acido arachidonico.

Logo MEDEST2Parliamo ora dei nuovi antiaggreganti piastrinici. Ha un vantaggio la loro somministrazione in fase preospedaliera, e la doppia antiaggregazione già a casa del paziente è un’opzione valida e priva di rischi

Siamo ancora in attesa dei risultati dei due grossi trial (ACCOAST ed ATLANTIS ndr) che indagano questo aspetto, anche se le prime indiscrezioni rivelano come un aumento dei sanguinamenti maggiori abbia costituito un elemento limitante perlomeno per uno di essi. Sicuramente i nostri dati indicano come l’attività antipiastirnica, sia del Prasugrel che del Ticagrelor  abbia bisogno di almeno 4 ore dalla LD (loading dose ndr) prima di raggiungere livelli efficaci

Logo MEDEST2Concordi quindi che in attesa di dati certi sull’efficacia e la sicurezza  dell’uso preospedaliero di questi nuovi antiaggreganti convenga concentrare le nostre energie sull’efficacia organizzativa e sulla riduzione dei tempi nel paziente con STEMI

Sicuramente la riduzione del tempo tra il FMC (first medical contact ndr) e l’arrivo del paziente alla porta dell’ospedale in questo momento garantisce un maggiore beneficio sull’outcome del paziente ed è quindi prioritario

Logo MEDEST2Ho notato che tu escludi a priori il Clopidogrel dall’uso in emergenza. Confermi quindi quelli che sono le indicazioni della review apparsa sul JAMA lo scorso anno: nessun beneficio, tempi d’azione lunghi, aumento dei rischio sanguinamento non giustificato.

Assolutamente si, riserverei l’utilizzo del Clopidogrel solo in pazienti selezionati e ne sconsiglio l’uso routinario in emergenza.

Logo MEDEST2Passiamo ora alle considerazioni sull’anticoagulante di scelta. Eparina non frazionata, a basso peso molecolare o cos’altro

L’eparina non frazionata (anche se di classe I B ndr) ha un suo ruolo visto il rapporto favorevolissimo tra impatto economico ed efficacia rispetto ad esempio alla Bivaluridina che ha costi estremamente elevati (attualmente non proponibili per la maggior parte dei sistemi d’emergenza ndr). Vorrei comunque puntualizzare come la via di somministrazione sottocutanea sia assolutamente da evitare; non ci permette infatti di misurare lo stato coagulativo del paziente che giunge in sala, e rende difficile un eventuale shift ad altri tipi di eparina che noi usiamo comunemente. Quindi eparina non frazionata, ma endovena ai dosaggi raccomandati dalle attuali linee guida.

Logo MEDEST2Leggendo i risultati del vostro trial, tra essi noto al punto 4 come la morfina rallenti l’attività antipiastrinica sia del Ticagrelor che del Prasugrel. Ci puoi dire di più a proposito

La morfina nell’analisi statistica retrospettiva è risultato un fattore di regressione negativo riguardo ad uno degli end-point secondari (HRPR high residual platelet reactivity ndr). Il rallentamento della motilità gastrica ed il vomito possono essere le spiegazioni di tale effetto; bisogna comunque anche evidenziare che i pazienti che ricevono morfina sono quelli tendenzialmente più sofferenti con un livello di vasocostrizione già elevato e precedente la somministrazione dell’oppiaceo.

Logo MEDEST2Quale atteggiamento consigli in funzione di tale osservazione riguardo all’analgesia del paziente STEMI, ed all’uso della morfina.

L’uso dei Nitrati (in aggiunta all’ASA ndr) come farmaco di primo impatto per l’analgesia potrebbe essere una scelta razionale che rimane nell’ambito delle evidenze attuali. Limiterei l’uso della Morfina ai casi di dolore refrattario a questo trattamento (obbligatorio l’uso di una scala di valutazione del dolore che ne permette il monitoraggio nel tempo ed il raggiungimento del target desiderato ndr) arginando così il numero di pazienti che ricevono oppiacei e rispettando allo stesso tempo il diritto all’analgesia

Logo MEDEST2Un oppiode di sintesi, fentanyl o remifentanyl ad esempio, potrebbe essere a tuo parere un’alternativa valida

Non sono a conoscenza di dati in merito. Potrebbe essere uno spunto di studio ulteriore.

Logo MEDEST2Infine una domanda che va oltre gli argomenti del trial ma che sta molto a cuore a tutti noi che lavoriamo sul territorio ed in emergenza in generale, e che riguarda anche voi cardiologi interventisti. I pazienti che recuperano un circolo sul territorio che tipo di priorità diagnostica dovrebbero avere una volta arrivati in DEA

A questo proposito non vi è dubbio, anche alla luce di dati oramai solidi e già recepiti della linee guida internazionali, che questi pazienti, a meno di una eziologia già chiaramente delineata in altro senso, penso al trauma all’evento neurologico ad esempio, dovrebbero di default effettuare uno studio coronarico per escludere cause ischemiche o predisponenti ad aritmie ipercinetiche ventricolari. In entrambi i casi la PCI rispettivamente  o il posizionamento di un ICD porterebbero alla cura ed alla dimissione precoce.

Logo MEDEST2Guido grazie e buon proseguimento del tuo lavoro

Grazie a voi tutti ed a presto.

Logo MEDEST2

Riassumiamo quindi i punti principali:

  • In attesa di dati certi, e viste le deboli evidenze sull’utilità dei nuovi antiaggreganti piastrinici, il loro uso routinario in emergenza al di fuori dall’ospedale non è raccomandato.

  • La somministrazione di ASA dovrebbe essere, ove possibile, effettuata per via e.v. ed a dosi piene.

  • L’uso della Morfina come analgesico di primo impatto per il paziente con STEMI da sottoporre a PCI dovrebbe essere scoraggiato; l’uso della Morfina dovrebbe essere riservato ai pazienti con VAS che premane elevata nonostante la somministrazione di ASA e Nitrati ev.

  • Tutti i pazienti con ROSC e con eziologia di ACR non già chiaramente delineata, dovrebbero effettuare uno studio coronarografico per escludere l’eziologia primitivamente ischemica o aritmica dell’arresto.

References:

Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study.

Department of Cardiology, Careggi Hospital, Florence, Italy. parodiguido@gmail.com

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