Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS TIMI 51 ATLAS ACS 2 –TIMI 51 * Gibson CM.

Slides:

Advertisements

Présentations similaires

unstable angina undergoing PCI.

Advertisements

PLATO Ticagrelor versus clopidogrel in patients with acute coronary syndromes undergoing coronary artery bypass surgery. Held C et al. ACC 2010.

JPAD The Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes Trial. Efficacy of Low-Dose Aspirin Therapy for the Primary Prevention.

EXCELLENT The randomized comparison of 6-month vs 12-month duration of dual antiplatelet therapy after the implantation of drug eluting stent. Gwon H-C,

Justification de l’utilisation des statines en prévention primaire

FUTURA/OASIS-8 Low versus standard dose unfractionned heparin for percutaneous coronary intervention in acute coronary syndrome patients treated with fondaparinux.

FINESSE Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events ESC 2007 FINESSE.

GRACE The Global Registry of Acute Coronary Events Montalescot G et al.

ATOLL Acute STEMI treated with primary PCI and intravenous enoxaparin or UFH to lower ischemic and bleeding events at short and long-term follow-up. Montalescot.

ABOARD* Essai multicentrique randomisé comparant une stratégie invasive immédiate versus différée chez des patients présentant un syndrome coronarien aigu.

Caractéristiques patients à l’inclusion

PEACE* Prévention par un IEC** (trandolapril) des accidents évolutifs graves chez des coronariens stables à fonction systolique ventriculaire gauche conservée.

ATLAS ACS 2 -TIMI 51 Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome.  Présentée.

TITRATION DU CLOPIDOGREL Tailored Clopidogrel Loading Dose according to Platelet Reactivity Monitoring Decrease Early Stent Thrombosis. Paganelli F et.

Apixaban versus warfarin in patients with atrial fibrillation

SYNTAX The synergy between percutaneous coronary intervention with TAXUS and cardiac surgery. Primary endpoint results at one year in the randomized cohort.

CARESS-AMI Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction ESC CARESS-AMI.

RE-LY Randomization Evaluation of Long-Term Anticoagulation Therapy Connolly S.J et al. N Engl J Med 2009 ; 361.

Registre MATRIX Long term safety of DES (drug eluting stents) in off-label use : results of the MATRIX registry. Dangas G.D et al. American College of.

TRITON-TIMI 38 Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes.

EXPLORE-Xa Betrixaban Compared With Open‑Label Dose-Adjusted Warfarin in Patients With Non-Valvular Atrial Fibrillation. Ezekowitz MD et al. ACC 2010.

EINSTEIN-DVT Oral rivaroxaban versus standard therapy for the acute and continued treatment of symptomatic deep vein thrombosis. Büller H et al. ESC 2010.

TRA-CER Vorapaxar, a platelet thrombin receptor antagonist, in acute coronary syndromes. Mahaffey KW et al . AHA 2011.

ISAR REACT 3A A trial of reduced dose of unfractioned heparin in biomarker negative patients undergoing percutaneous coronary intervention. Schulz S et.

un infarctus du myocarde récent.

Platelet inhibition with cangrelor in patients undergoing PCI.

PRODIGY Prolonging dual antiplatelet treatment after grading stent-induced intimal hyperplasia study Valgimigli M et al. ESC 2011.

ROCKET AF Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in Atrial.

TRITON-TIMI 38 Evaluation of Prasugrel Compared with Clopidogrel in Patients with Acute Coronary Syndromes and Planned Percutaneous Coronary Intervention:

PRAGUE 7 Primary angioplasty in patients from general hospital transported to cathlab units with/without emergency thrombolysis Widimski P et al.

EARLY-ACS Inhibition de la glycoprotéine IIb/IIIa dans le syndrome coronarien aigu sans sus-décalage de ST Newby K et al. ACC Anti-GPIIb/IIIa précoce.

Intravenous platelet blockade with cangrelor during PCI.

NORDISTEMI Norwegian study on district treatment of ST-elevation myocardial infarction Halvorsen S. et al.

TRITON-TIMI 38 Trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-thrombolysis in myocardial infraction.

AVERROES Apixaban versus acetylsalicylic acid (ASA) to reduce the risk of stroke Connolly S et al. ESC 2010.

Revascularisation coronaire : ATL-endoprothèses ou chirurgie ?

AIDA STEMI The abciximab intracoronary versus intravenously drug application in ST-elevation myocardial infarction (AIDA STEMI). Thiele H et al. AHA 2011.

ISAR-REACT 4 The abciximab intracoronary versus intravenously drug application in ST-elevation myocardial infarction (AIDA STEMI). Kastrati A et al. AHA.

ICTUS Comparaison entre revascularisation coronaire précoce

OASIS-5 Comparaison du fondaparinux à l’énoxaparine dans le syndrome coronarien aigu Comparison of fondaparinux and enoxaparin in acute coronary syndromes.

Prasugrel vs Clopidogrel for Patients managed with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography : a secondary,

RE-COVER Dabigatran versus warfarine dans le traitement d’un accident thrombo-embolique veineux Schulman S et al. N Engl J Med 2009 ;361: Dabigatran.

Clopidogrel with aspirin in acute minor stroke or transient ischemic attack CHANCE Wang Y et al. N Engl J Med 2013 ;369:11-19.

Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban once daily, oral,

CHARISMA Analyse post-hoc Complications hémorragiques de l’association clopidogrel + aspirine chez les patients avec maladie vasculaire stable ou avec.

ISAR-SAFE, ITALIC, DAPT Durée de la bithérapie AAP post ATL-stent actif Schulz-Schüpke S, et al. ISAR-SAFE, Gilard M, et al. ITALIC, Mauri L, et al. DAPT.

PRAGUE-14 Perioperative cardiovascular complications versus perioperative bleeding in patients with cardiovascular complications undergoing noncardiac.

LODOCO Low Dose Colchicine for Secondary Prevention of Cardiovascular Disease Nidorf M et al. AHA 2012.

FREEDOM Strategies for Multivessel Revascularization in Patients with Diabetes N Engl J Med 2012 DOI : /NEJMoa Farkouh ME et al. AHA 2012.

Host-ASSURE Adjunctive Cilostazol vs double dose clopidogrel after PCI with drug eluting stent Hyo-Soo K et al. ACC 2012.

RE-LY Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial.

TRA 2° P Vorapaxar in the secondary prevention in atherothrombotic events Morrow DA et al. N Engl J Med 2012 ; 366 : Morrow DA et al. ACC 2012.

Oral rivaroxaban for symptomatic venous thromboembolism

Low-Molecular-Weight Heparin and Mortality in Acutely Ill Medical Patients. LIFENOX Kakkar A.K, et al. N Engl J Med 2011 ; 365 :

CHARISMA Clopidogrel + aspirine contre aspirine seule pour la prévention des accidents athérothrombotiques. Bhatt DL et al. N Engl J Med 2006;354:

ARISTOTLE Apixaban versus warfarine dans la fibrillation atriale

POISE-2 Aspirin in patients undergoing noncardiac surgery ACC Devereaux P.J, et al. N Engl J Med 2014 ; 370 :

Recombinant Administration of Ticagrelor in the cath lab or in the ambulance for new ST elevation myocardial infarction to open the coronary artery ATLANTIC.

Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism HOKUSAI-VTE Büller HR et al. N Engl J Med 2013 ; 369 :

Prasugrel vs Clopidogrel for Acute Coronary Syndromes without Revascularization TRILOGY ACS Roe MT et al. N Engl J Med 2012 ; 367:

WOEST First randomised trial comparing two regimens with and without aspirin in patients on oral anticoagulant therapy undergoing coronary stenting. Dewilde.

ATLAS ACS 2 – TIMI 51 Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome Gibson CM.

ATLANTIC Administration of Ticagrelor in the cath lab or in the ambulance for new ST elevation myocardial infarction to open the coronary artery Montalescot.

ATLAS ACS-TIMI 46 Rivaroxaban versus placebo dans le SCA

WOEST First randomised trial comparing two regimens with and without aspirin in patients on oral anticoagulant therapy undergoing coronary stenting. Dewilde.

ACCOAST Pretreatment with prasugrel in non-ST elevation acute coronary syndromes ESC 2013 Montalescot G, et al. N Engl J Med 2013.

Strategies for Multivessel Revascularization in Patients with Diabetes

TRA 2° P Vorapaxar in the secondary prevention in atherothrombotic events Morrow DA et al. N Engl J Med 2012 ; 366 : Morrow DA et al. ACC 2012.

Host-ASSURE Adjunctive Cilostazol vs double dose clopidogrel after PCI with drug eluting stent Hyo-Soo K et al. ACC 2012.

TRILOGY ACS Prasugrel vs Clopidogrel for Acute Coronary Syndromes Patients managed without Revascularization. Ohman M, et al. ESC 2012.

Transcription de la présentation:

Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS TIMI 51 ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Rappel Dans l’étude princeps de Mega JL et al. (N Engl J Med 2012 ; 366 : 9-19), la tri-thérapie anti-thrombotique (BiAAP + rivaroxaban, anti-Xa oral) dans le post- syndrome coronaire aigu récent apportait une diminution significative des évènements CV graves, au prix d’un surcroît d’accidents hémorragiques majeurs. * ETUDE ANCILLAIRE ATLAS ACS 2 –TIMI 51 *

Méthodes Objectif Évaluation de la tri-thérapie anti-thrombotique contre placebo dans la prévention des thromboses de stent chez les patients traités par ATL + ≥ 1 stent pour un SCA de l’étude ATLAS ACS2-TIMI 51(analyse pré- définie) Etude Étude phase III, randomisée, multicentrique, internationale (44 pays,766 sites). Critères d’inclusion Patients en post-SCA ST+, ST-, stables depuis 1 à 7 jours, sans risque hémorragique * ETUDE ANCILLAIRE Gibson CM et al. JACC 2013 ; 62 : ATLAS ACS 2 –TIMI 51 *

Schéma de l’étude Post-SCA ST+, ST- stable depuis 1-7 j sans risque hémorragique n = R Rivaroxaban 2,5mg x2/j ou 5mg x2/j (n=6433) Durée de suivi : 2 ans Critère de jugement principal Thrombose de stent certaine, probable, possible selon la définition de l’ARC (Academic Research Consortium) Aspirine mg + Thiénopyridine + ATL-stent (n=9631, 63%) Placebo n = 3198 ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Patients CARACTERISTIQUES Rivaroxaban (2,5 mg X 2/j + 5 mg x 2/j) (n = 6433) placebo (n = 3198) p Âge moy. (ans)61,7 ± 8,961,1 ± 8,9< 0,001 Hommes (%)7978,40,003 AtcdsIDM (%) HTA (%) Diabète type 2 (%) 25, ,9 25,7 63,4 30,5 0,557 0,518 0,666 Tabac (%) 43,243,70,596 Type SCA (%) ST+ ST- Instable 55,6 25,8 18,6 56,1 25,8 18,1 0,856 (tous types) Index de revascularisation (%) ATL PAC ATL ou PAC 92,3 0,1 92,4 92,1 0,1 92,2 0,709 1,000 0,688 TraitementAspirine (%) Thiénopyridine (%) ß-bloquant (%) IEC ou ARA2 (%) Statine (%) Inhib. Calc. (%) 98,1 97,1 66,9 39,0 88,8 14,7 98,3 97,2 68,4 39,8 88,9 14,2 0,618 0,733 0,148 0,429 0,911 0,531 ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Résultats Critère principal Taux cumulé d’évènements (%) 3 placebo Rivaroxaban (2,5 et 5 mg) 1,9% RRR - 35% mTT p = 0,017 ITT p = 0,008 Mois post-randomisation ,5% placebo Rivaroxaban (2,5 et 5 mg) 2,9% RRR - 31% mTT p = 0,016 ITT p = 0,008 Mois post-randomisation ,3% ARC certain/probable RRR - 35% mTT p = 0,017 ITT p = 0,012 Thrombose de Stent (certaine, probable) Thrombose de Stent (certaine, probable) Thrombose de Stent (certaine, probable, possible) Thrombose de Stent (certaine, probable, possible) ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Résultats Critère principal 2,3% 2,9% Thrombose Stent (certaine, probable, possible) Thrombose Stent (certaine, probable) Thrombose Stent (certaine) 2,2% % patients 0 3,5 2,5 p = 0,016* 1,5% 1,9% 1,5% p = 0,017* 1% 1,3% 1,1% p = 0,058* Rivaroxaban 2,5 – 5 mg groupés Rivaroxaban 2,5 mg Rivaroxaban 5 mg placebo *p = comparaison Rivaroxaban 2,5 – 5 mg groupés contre placebo Thrombose de Stent ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Résultats Critère principal ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Résultats ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE

Conclusion Dans le SCA (ST+, ST-) traité par ATL + stent : l’adjonction de rivaroxaban (anti-Xa direct, oral, 2.5 mg x 2/j) à une bithérapie AAP (aspirine, thiénopyridine) entraîne une diminution significative des thromboses du stent et de la mortalité CV. ATLAS ACS 2 –TIMI 51 * Gibson CM et al. JACC 2013 ; 62 : * ETUDE ANCILLAIRE