Indicazione, efficacia e sicurezza dello switching tra terapie antiaggreganti piastiniche
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1 Indicazione, efficacia e sicurezza dello switching tra terapie antiaggreganti piastiniche Guido Parodi Dipartimento CardioToracoVascolare Azienda Ospedaliero-Universitaria Careggi Firenze CardioLucca Lucca, 28 Novembre 2014
2 SWITCHING OPTIONS DOWNGRADE CLOPIDOGREL UPGRADE PRASUGREL TICAGRELOR CHANGE
3 SWITCHING OPTIONS CLOPIDOGREL UPGRADE PRASUGREL TICAGRELOR
4 EYESHOT Registry Switching of P2Y12 inhibitor in patients with ACS: Insights from EYESHOT Registry (3 weeks: ) N = 2585 ACS patients (1707 PCI) 242 (14.2%) SWITCHING N= 164 (68%) UPGRADE Clop Tica/Pras N= 55 (23%) DOWNGRADE Pras/Tica Clop N= 23 (9%) CHANGE Tica Pras Switching of P2Y12 inhibitor mostly represents upgrade from clopidogrel to ticagrelor or prasugrel but it is not frequent practice.
5 EYESHOT Registry P2Y12 Inhibitors at Discharge By Strategy NSTE-ACS N=1475 STEMI N= , ,4 35,9 34,6 36, ,1 % % n=242 n=384 n=811 n=38 n=39 n=81 n=903 n=11 No ADP Inhib (clopi/tica/prasu/ticlo)
6 PLATO study UA/NSTEMI (moderate-to-high risk) STEMI (if primary PCI) All receiving ASA; clopidogrel-treated (46%) or naive (54%); randomised within 24 hours of index event (N=18,624) Clopidogrel If pre-treated, no additional loading dose; if naive, standard 300 mg loading dose, then 75 mg qd maintenance; (additional 300 mg allowed pre PCI) Ticagrelor 180 mg loading dose, then 90 mg bid maintenance; (additional 90 mg pre-pci) Wallentin L et al. N Engl J Med. 2009;361:
7 PLATO study Wallentin L et al. N Engl J Med. 2009;361:
8 The RESPOND Study Inhibition of platelet aggregation in clopidogrel responders (n=57 stable CAD patients) Gurbel PA et al. Circulation 2010:121:
9 Brar SS et al. J Am Coll Cardiol 2011;58:
10 cardiovascular death, nonfatal myocardial infarction, or stroke
11 P2Y 12 INHIBITORS 15%
12 The SWAP Study Switching AntiPlatelets (n=139 ACS patients) * p< vs clopidogrel 75 mg MD p< vs prasugrel 10 mg MD Angiolillo D et al. J Am Coll Cardiol 2010:56:1017
13 Previous clopidogrel load = 90 pts Prasugrel only load=516 pts Loh JP. Am J Cardiol 2013
14 Parodi G. J Thr Thombol 2014
15 Paper Patient population Pts switched to prasugrel 1. Payne CD, et al. Platelets. 2008;19(4): Healthy subjects Wiviott SD, et al; PRINCIPLE-TIMI 44 trial. Circulation. 2007;116(25): CAD with planned PCI Montalescot G et al. ACAPULCO study. Thromb Haemost. 2010;103(1): UA/NSTEMI ACS Diodati JG, et al. TRIPLET trial. Circ Cardiovasc Interv Oct 1;6(5): ACS anticipated to undergo PCI Angiolillo DJ, et al; SWAP study. J Am Coll Cardiol. 2010;56(13): post-acs pts Alexopoulos D, et al, Am Heart J Jan;165(1):73-9. Elderly ACS PCI Capranzano P, et al. Thromb Haemost 2011;106: Elderly ACS PCI Angiolillo DJ et al. OPTIMUS-3 Trial. Eur Heart J ;32: type 2 DM and CAD Cuisset T et al. Int J Cardiol 2013;168: diabetic PCI patients Sardella G et al. RESET GENE trial. Circ Cardiovasc Interv ;5: stable patients undergoing PCI Alexopoulos D, et al. JACC Cardiovasc Interv. 2011;4: PCI w stent Alexopoulos D, et al. J Thromb Haemost. 2011;9: chronic HD with CAD Alexopoulos D, et al. Am Heart J. 2011;162: Stable CAD, 87% undergoing PCI pts switched from clopidogrel to prasugrel 14. Loh JP et al. Am J Cardiol Mar 15;111(6): ACS PCI Lhermusier T, et al. J Thromb Haemost. 2012;10: ACS PCI Nührenberg TG, et al. Platelets. 2013;24: STEMI PCI Aradi D, et al. J Am Coll Cardiol. 2014;63: ACS PCI Parodi G, et al. J Thromb Thrombolysis [Epub ahead of print] STENTED PCI De Luca G, et al. J Thromb Thrombolysis [Epub ahead of print] ACS PCI Alexopoulos D, et al. Am Heart J. 2014;167:68-76.e2. ACS PCI Trenk D et al, TRIGGER-PCI (study. J Am Coll Cardiol 2012;59: NSTE-ACS medically managed Roe MT et al, TRILOGY ACS trial. N Engl J Med. 2012;367: NSTE-ACS medically managed Bagai A et al, Circ Cardiovasc Interv. 2014;7: Acute MI and PCI SCAAR Registry. ACS PCI Clemmensen P et al., MULTIPRAC Registry. EHJ:ACC [Epub ahead of print] STEMI PCI 553
16 Pharmacodynamic Endpoints Primary Endpoint: PRU at 6 hrs 400 P=0.188 median 300 VN-P2Y12 PRU placebo/ pras 60 mg clop 600 mg/ pras 60 mg clop 600 mg/ pras 30 mg n= 43 n= 38 n= 45 Diodati J and Angiolillo DJ. Circ Cardiovasc Interv 2013; 6(5):567-74
17 Prasugrel LD Alone vs. Clopidogrel + Prasugrel LDs PRASUGREL LD ALONE CLOPIDOGREL + PRASUGREL LDs PRASUGREL (AM) CLOPIDOGREL (AM) Platelet P2Y12 Receptor AM=Active Metabolite; LD=Loading Dose, PD=Pharmacodynamic Diodati J and Angiolillo DJ. Circ Cardiovasc Interv 2013; 6(5):567-74
18 2011
19 SWITCHING OPTIONS DOWNGRADE CLOPIDOGREL PRASUGREL TICAGRELOR
20 DOWNGRADING Background Prasugrel Clopidogrel 1)Increase of platelet aggregation (10-fold) 2) Unmask poor responder to clopidogrel 3) Reduce minor bleeding Kerneis M et al. JACC Cardiovac Interventions 2013
21 SWITCHING OPTIONS CLOPIDOGREL PRASUGREL TICAGRELOR CHANGE
22 SWAP 2 Ticagrelor Prasugrel PRU (mean ± SD) Prasugrel 60 mg LD/ 10 mg MD Prasugrel 10 mg MD Prasugrel Total Ticagrelor Pre-Run-In Baseline Pre- Rand. Baseline 2 hrs Post First Rand. Dose 4 hrs Post First Rand. Dose 24 hrs Post First Rand. Dose 48 hrs Post First Rand. Dose 7 Days Post First Rand. Dose Angiolillo D. J Am Coll Cardiol 2014
23 Sudden cardiac death of a patient with LM stent 48 hours after switching from Ticagrelor to Prasugrel without loading dose.
24 Parodi G and Storey RF. Eur Heart J: ACC 2014; Sep 29
25 Was identical characteristics, frequency and severity of DYSPNOEA episodes present before starting TICAGRELOR? NO YES Is the DYSPNOEA associated with orthopnoea, paroxysmal nocturnal dyspnoea or chest tightness or pain, related to exertion or limiting exercise capacity and/or is there an identifiable cause on physical examination? YES Look for an alternative cause NO Spontaneous DYSPNOEA improvement within 3 days Can the patient tolerate the DYSPNOEA with appropriate reassurance and counselling? NO NO Possible ticagrelorrelated DYSPNOEA Consider switching to prasugrel (or clopidogrel if prasugrel is contraindicated) using a full loading dose at least 24 hours from the last ticagrelor intake YES YES FOLLOW-UP Parodi G and Storey RF. Eur Heart J: ACC 2014; Sep 29
26 CONCLUSIONS 1) Switching from Clopidogrel to Ticagrelor or Prasugrel reduces platelet reactivity 3) Whether to switch depend on risk profile (anatomy) 4) How to switch: starting with a loading dose 5) Downgrading to clopidogrel should be considered only in the case of relevant sideeffect or of the need for oral anticoagulation 6) A warning regarding switching from ticagrelor to prasugrel (or clopidogrel)!
27 MOST FREQUENT SWITCH
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