Monitoring - Intranet

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Monitoring - Intranet

ARCTIC investigators sARCTIC: Assessment by a double Randomization of a Conventional antiplatelet strategy versus a monitoring-guided strategy fordrug-eluting stent implantation and, of Treatment Interruption versus Continuation one year after stenting - NCT 00827411 -COI DISCLOSURE FOR DR. MONTALESCOT: Research Grants to the Institution or Consulting/Lecture Fees from Abbott Vascular,Astra-Zeneca, Bayer, Biotronik, Boehringer-Ingelheim, Boston Scientific, Cleveland Clinic Foundation, Cardiovascular ResearchFoundation, Cordis, Daiichi-Sankyo, Duke institute, Eli-Lilly, Europa, Fédération Française de Cardiologie, Fondation de France,GSK, ICM, INSERM, Medtronic, Menarini, Nanospheres, Novartis, Pfizer, Sanofi-Aventis Group, Servier, Société Française deCardiologie, The Medicines Company, TIMI group.


Centers and principal investigatorsCHU Pitié-Salpêtrière, Paris, Drs Montalescot/ColletHôpital de la Timone, Marseille, Dr CuissetCH de Chartres, Dr RangéCHU Carémeau, Nîmes, Drs Ledermann/CaylaCH de Lagny, Marne-la-Vallée, Drs Elhadad/CohenClinique Sainte Clothilde, La Réunion, Dr PouillotCH Clermont-Ferrand, Dr MotreffHôpital Lariboisière, Paris, Dr HenryHôpital de Rangueil, Toulouse, Dr CarriéCH de la Région Annecienne, Annecy, Dr BelleCH de Bastia, Dr BoueriHôpital Cardiologique Albert Calmette, Lille, Dr Van BelleGH du Centre Alsace, Drs Lhoest/LevaiHôpital Nord Marseille, Dr PaganelliCHU Jean Minjoz, Besançon, Dr BassandClinique du Parc, Castelnau-le-Lez, Dr ShadfarPolyclinique de Bordeaux Caudéran, Bordeaux, Dr CasteigtCH Marie Lannelongue, Le Plessis-Robinson, Dr CaussinHôpital François Mitterrand, Pau, Dr DelarcheHôpital Pasteur, Nice, Dr FerrariClinique du Tonkin, Villeurbanne, Dr ChampagnacCHU de Poitiers, Dr ChristiaensHôpital Arnaud de Villeneuve, Montpellier, Dr LeclercqHôpital Cardio-Vasculaire Louis Pradel, Lyon, Dr FinetHôpital Saint-Joseph, Marseille, Dr D’HoudainClinique de l’Europe, Amiens, Dr PyHôpital privé Beauregard, Marseille, Dr WittenbergCH de Cannes, Drs Tibi/ZemourCHR Strasbourg, Dr OhlmannHôpital Cochin, Paris, Dr VarenneCH d’Avignon, Drs Pansieri/BarneyHôpital Cardiologique du Haut Lévêque, Pessac, Dr CosteCH Lens, Dr PecheuxClinique de l'Orangerie, Strasbourg, Dr AleilClinique Nantaise, Nantes, Dr BrunelCH de Compiègne, Dr SayahHôpital Pontchaillou, Rennes, Dr Le BretonCH Dijon, Dr Cottin


Background100Cardiac Death and ST959085P


GRAVITAS / TRIGGER-PCI designsCoronary angiogramStent-PCIScreening 24hrs after PCIwith VerifyNow P2Y12High platelet reactivity(PRU ≥ 230)RdClopi High DoseClopidogrel/ Prasugrel Standard Dose6-month FUPrice MJ et al. JAMA 2011;305:1097–105Trenk D et al. J Am Coll Cardiol 2012;59:2159–64.


ARCTIC trial designCoronary angiogramRdVerifyNowP2Y12 + ASADrug (ASA, clopidogrel,prasugrel, GP2b3a I.)and Dose adjustmentsif high platelet reactivityStent-PCIDrug (ASA,clopidogrel, prasugrel)and Dose adjustmentsat day 14Standard of careStent-PCIStandard of carePrimary endpoint at 12 months:• Death, MI, stroke, stent thrombosis,urgent revascularizationStatistical considerations:• Assuming an annual risk of 9% and a33% relative risk reduction (α risk at5% and error β at 80%, bilateral test),2,466 patients were necessary todemonstrate the superiority of thestrategy of monitoring and adjustment12-month FUARCTIC study protocol - Collet JP, et al. Am Heart J 2011;161:5-12


Inclusion / Exclusion• Patients scheduled for planned PCI• DES implantation• Consent and Rx before start of PCI• Primary PCI for STEMI• Any PCI with planned use ofGPIIbIIa• BMS or oral anticoagulationrequirement• Short life expectancy• Bleeding diathesis


Adjustment rulesDES-PCIARU>550 (Aspirin)%inh235 (P2Y12)GPIIb/IIIa+ clopidogrel (re)LD (>600 mg)or prasugrel LD 60 mg then,MD clopidogrel 150 mg or prasugrel 10mg


Adjustment rulesVerifyNow @ day 14-30ARU>550%inh235%inh>90%Doubling the aspirin dose ↗ Clopidogrel dose by at least 75mg or switch to prasugrel 10mg*if clopidogrel 150mg ↘ 75mgif prasugrel clopidogrel 75mg


Baseline characteristicsConventional(n=1227)Monitoring(n=1213)Age - median 63 63Diabetes - % 37 36Prior MI - % 31 29Prior PCI - % 44 42Prior CABG - % 7 6Beta blockers -% 60 56Proton pump inhibitors - % 32 33Stent implanted - % 98 98Drug-eluting stent implanted - % 97 97


In-Lab monitoring and adjustmentConventional(n=1227)Monitoring(n=1213)Aspirin poor responders - % NA 7.6On-table aspirin loading in poor responders - % NA 85Thienopyridine poor responders - % NA 35 On-table clopi. loading in poor responders - % NA 80 On-table prasu. loading in poor responders - % NA 3.3 On-table GP IIbIIIaloading in poorresponders - %NA 80


Day-14 monitoring and adjustmentCath labDay 14High on-clopidogrelreactivityHigh on-aspirinreactivity43%hadtheirclopidogrelMDincreaseded17%weree put onprasugrelMD46% hadtheiraspirinin MD increaseded


Main Secondary Endpoint to 1 yearStent thrombosis or urgent revascularizationMonitoringConventionalHR = 1.06 [0.74-1.52]p= 0. 774.9%0100 200 3004.6%


Primary EndpointPre-specified subgroupsMain Secondary Endpoint


Other Ischemic EndpointsConventional Monitoring HR [95%CI] PDeath or myocardial Infarction - % 28.8 31.7 1.11 [0.96; 1.29] 0.15Any death - % 1.6 2.3 1.41 [0.79; 2.50] 0.24Myocardial infarction - % 28.4 30.3 1.08 [0.93; 1.25] 0.32Stent thrombosis - % 0.7 1 1.34 [0.56; 3.18] 0.51Stroke or TIA- % 0.6 0.7 1.15 [0.42; 3.18] 0.78Urgent revascularization - % 4.2 4.5 1.06 [0.73; 1.55] 0.76


Key Safety OutcomesConventional Monitoring HR [95%CI] PMajor bleeding - % 3.3 2.3 0.70 [0.43; 1.14] 0.15Minor bleeding - % 1.7 1.0 0.57 [0.28; 1.16] 0.12Major or minor bleeding - % 4.5 3.1 0.69 [0.46; 1.05] 0.08STEEPLE definitions - Montalescot G, et al. N Engl J Med 2006; 355:1006–17


1. PFT + antiplatelet therapy adjustment before and afterstenting does not improve clinical outcome as comparedwith standard treatment without PFT.2. Our data do not support routine use of PFT in patientsundergoing stenting.3. ARCTIC-2 continues: 2 nd randomization for continuation vs.interruption of clopidogrel at 1 year follow-up.4. ANTARCTIC (NCT01538446) evaluates the value of PFT inthe elderly population with a paradigm shift towards safety.PFT: Platelet Function Testing

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