DOUBLE or TRIPLE ANTI-TROMBOTIC THERAPY in ACS. Maarten L Simoons Thoraxcenter - Erasmus MC Rotterdam - The Netherlands
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1 DOUBLE or TRIPLE ANTI-TROMBOTIC THERAPY in ACS Maarten L Simoons Thoraxcenter - Erasmus MC Rotterdam - The Netherlands
2 RECENT DEVELOPMENTS Better anti-platelet agents: Prasugrel and Ticagrelor to replace Clopidogrel in patients treated with aspirin New anticoagulants: Voraxapar: thrombin receptor antagonist Apixaban, Rivaroxaban: factor Xa inhibitors administered on top of Aspirin and Clopidogrel
3 RECENT DEVELOPMENTS Better anti-platelet agents: Prasugrel and Ticagrelor to replace Clopidogrel in patients treated with aspirin. New anticoagulants: Voraxapar: thrombin receptor antagonist Apixaban, Rivaroxaban: factor Xa inhibitors administered on top of Aspirin and Clopidogrel Dose selection - Double- or triple therapy?
4 DOSE SELECTION - PHASE 2 To evaluate the effect on bleeding (safety) vs. placebo of different doses of Voraxapar / Apixaban / Rivaroxaban in patients with recent ACS on Aspirin (+Clopidogrel) Double / Triple therapy To assess (preliminary) efficacy To determine the optimal dose for phase 3 Treatment up to 6 months after ACS event
5 ATLAS-ACS BLEEDING RATES Clinical significant bleeding % Requiring medical attention, Lancet 2009 ASA ASA + Clopidogrel 14,3 10 8,7 9,7 9,8 4,3 3,4 1,7 2, Plac plac Rivaroxaban
6 ATLAS-ACS ISCHEMIC OUTCOME 13,9 Death, MI, stroke, SRI % Lancet 2009 ASA ASA + Clopidogrel 6,6 8,7 8 5,1 4 3,4 6,5 6 Plac plac Rivaroxaban
7 ATLAS-ACS ISCHEMIC OUTCOME 13,9 Death, MI, stroke, SRI % Lancet 2009 ASA ASA + Clopidogrel 6,6 8,7 8 5,1 Phase 3 4 3,4 6,5 6 Plac plac Rivaroxaban
8 TRACER - ATLAS-ACS - APPRAISE-2 TRACER: Voraxapar vs placebo Protease-activated-receptor antagonist inhibits thrombin induced platelet aggregation 12,944 patients, 1 day after ACS ATLAS-ACS: Rivaroxaban 2 doses vs placebo Factor Xa inhibitor 15,526 patients, 5 days (3 6) after ACS APPRAISE-2: Apixaban vs placebo Factor Xa inhibitor 7392 high risk patients, 6 days (4 7) after ACS
9 TRACER ATLAS-ACS APPRAISE-2 Voraxapar Rivarox. Apixaban Patients 12,944 15, Age (yr) Female (%) Previous MI (%) Diabetes (%) STEMI (%) ASA (%) Thienopyr. (%) CABG/PCI (%)
10 TRACER ATLAS-ACS APPRAISE-2 Voraxapar Rivarox. Apixaban Patients 12,944 15, Death CV death MI Stroke IC bleeding Events / 100 pts / yr, placebo group
11 TRACER - ATLAS-ACS - APPRAISE-2 Different final results APPRAISE-2 / TRACER stopped upon recommendation DSMB because of bleeding excess, with sufficient endpoints (TRACER) and without indication of benefit (APPRAISE-2) ATLAS-ACS continued, Significant reduction of CV death, MI, stroke at 13 m (mean), with increasing separation of event curves after the first year
12 TRACER VORAXAPAR after ACS 12,944 NonSTEMI, 1 day after admission Median follow-up 502 d 2 yr event rates p=0.07 (ns) ns 0.02 ns < plac vorax CV-death MI stroke death MI stroke major bleed TRACER Tricoci et al. NEJMed 2011
13 APPRAISE-2 APIXABAN after ACS 7392 STEMI / NonSTEMI, 6 d after admission median follow-up 8m events / 100 pts / yr p=ns plac apix ns ns ns CV-death MI stroke death MI stroke major bleed APPRAISE-2 Alexander et al. NEJMed
14 ATLAS-ACS RIVAROXABAN after ACS 15,526 STEMI / NonSTEMI, 5 d after admission median follow-up 13 m 2 yr event rates p=0.002 ns 0.01 ns < plac 8.8 rivarox CV-death MI stroke p= death MI stroke major bleed ATLAS-ACS Mega et al. NEJMed 2011
15 TRACER - ATLAS-ACS - APPRAISE-2 CV-death, MI, stroke (2 year follow-up) P = ns ns Voraxapar 2.5 Rivarox 2 x 2.5 Rivarox 2 x 5 Apixaban 2 x 5 rate/100/2yr
16 TRACER - ATLAS-ACS - APPRAISE-2 Death (2 year follow-up) P = ns ns ns Voraxapar 2.5 Rivarox 2 x 2.5 Rivarox 2 x 5 Apixaban 2 x 5 rate/100/2yr
17 TRACER - ATLAS-ACS - APPRAISE-2 MI (2 year follow-up) P = 0.02 ns ns Voraxapar 2.5 Rivarox 2 x 2.5 Rivarox 2 x 5 Apixaban 2 x 5 rate/100/2yr
18 TRACER - ATLAS-ACS - APPRAISE-2 Stroke (2 year follow-up) P = ns ns ns ns Voraxapar 2.5 Rivarox 2 x 2.5 Rivarox 2 x 5 Apixaban 2 x 5 rate/100/2yr
19 TRACER - ATLAS-ACS - APPRAISE-2 TIMI major bleed, non CABG (2 year follow-up) P < < < Voraxapar 2.5 Rivarox 2 x 2.5 Rivarox 2 x 5 Apixaban 2 x 5 rate/100/2yr
20 BLEEDING DEFINITIONS GUSTO TIMI TIMI ISHT severe major minor major Fatal Intra cranial Critical organ + Non-overt (Hb ) > 4 Overt (Hb mg%) > 5 > 3 > 2 With intervention +* Transfusion > 2 +* hemodynamic compromise
21 TRACER - ATLAS-ACS - APPRAISE-2 Clinically significant bleed (2 year follow-up) P < < < Voraxapar 2.5 Rivarox 2 x 2.5 Rivarox 2 x 5 Apixaban 2 x 5 rate/100/2yr
22 TRACER - ATLAS-ACS - APPRAISE-2 Overall conclusion Triple therapy (ASA + clopidogrel + TR-Antag / Xa inhibition) in patients with / after ACS (1 d / 1 wk 2 yr) - reduces myocardial infarction - at the cost of bleeding - no consistent effect on stroke or mortality
23 TRACER - ATLAS-ACS - APPRAISE-2 Similar (un) safety Increased bleeding rates: Intra Cranial Bleeds: VORAXAPAR HR = 3.4 APIXABAN HR = 4.1 (5mg) RIVAROXABAN HR = 3.7 (5mg) 2.8 (2.5mg) TIMI-major bleeds, non-cabg: VORAXAPAR HR = 1.9 APIXABAN HR = 2.6 (5mg) RIVAROXABAN HR = 4.5 (5mg) 3.5 (2.5mg)
24 TRACER - ATLAS-ACS - APPRAISE-2 Different final results APPRAISE-2 / TRACER stopped upon recommendation DSMB because of bleeding excess, with sufficient endpoints (TRACER) and without indication of benefit (APPRAISE-2) ATLAS-ACS continued, Significant reduction of CV death, MI, stroke at 13 m (mean), with increasing separation of event curves after the first year: HR 0.85, p=0.03 (5mg) HR 0.84, p=0.02 (2.5mg) Reduction of death with 2.5mg, explanation??
25 APIXABAN - RIVAROXABAN death, MI, ischemic stroke
26 ATLAS-ACS - APPRAISE-2 Overall conclusion: Triple therapy (ASA + clopidogrel + Xa inhibition) reduces thrombotic events, in patients at low risk after ACS (1 wk 2 yr), as in ATLAS-ACS, but not in higher risk patients as in APPRAISE-2. Age 65 years, markers + ST deviation, diabetes mellitus, Prior MI, ischemic stroke, TIA, asymptomatic carotid stenosis, PAD, prior symptomatic CHF or LVEF <40%, non-revascularised multi-vessel CAD, mild / moderate renal insuff. (CrCl <90 ml/min)
27 ATLAS-ACS RIVAROXABAN after ACS 10,227 STEMI / NonSTEMI, 5 d after admission median follow-up 13 m 2.5mg 2 yr event rates p= ns ns < plac rivarox 2.5 CV-death MI stroke p= death MI stent major thrombosis bleed Mega et al. NEJMed 2011
28 PRASUGREL - TICAGRELOR Prasugrel Clop Pras Clop Tica CV death MI, stroke death MI Ticagrelor stent thromb. major bleed non-cabg
29 ATLAS-ACS - TRITON - PLATO CV-death, MI, stroke TIMI major bleed riva pras tica ATLAS TRITON PLATO 2 yr 1 yr 1 yr ATLAS TRITON PLATO
30 ATLAS-ACS - TRITON - PLATO Final conclusion: Triple therapy (ASA + clopidogrel + Xa inhibition) reduces thrombotic events, at the cost of bleeding in patients after ACS. Reduction of CV-death, MI, Stroke and increase of bleeding with triple therapy similar to ASA + prasugrel (TRITON) or + ticagrelor (PLATO). ASA + prasugrel / ticagrelor, the best choice.
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