Στεφανιαίος ασθενής με μη βαλβιδική Κολπική Μαρμαρυγή - Νέες στρατηγικές

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1 4 ο ΠΑΝΕΛΛΗΝΙΟ ΑΡΡΥΘΜΙΟΛΟΓΙΚΟ ΣΥΝΕΔΡΙΟ ΣΕΠΤΕΜΒΡΙΟΥ 2018 HILTON, ΑΘΗΝΑ Στεφανιαίος ασθενής με μη βαλβιδική Κολπική Μαρμαρυγή - Νέες στρατηγικές Ι. Κανακάκης MD, PhD Διευθυντής Αιμοδυναμικού Τμήματος Θεραπευτική Κλινική Πανεπιστημίου Αθηνών ΓΝΑ «Αλεξάνδρα»

2 Disclosure Speaker honoraria ASTRA ZENECA BOEHRINGER INGELHEIM BAYER

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5 The Optimal Management of Atrial Fibrillation and ACS Differ ticlopidine Lancet 2006 Jun 10;367(9526): N Eng J Med 1998 Dec 3;339(23):

6 Clinical Challenge in Patients With AF Undergoing PCI

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8 Risk of stent thrombosis (ST), stroke and bleeding 1. ST: 1 st month 2. Stroke: steady (CHA 2 DS 2 -VASc score) 3. Bleeding: with the number of antithrombotic CS High in the first 3 months

9 Cumulative incidence (%) WOEST Trial Dual antithrombotic therapy excluding ASA reduces bleeding risk vs triple therapy without compromise on efficacy Cumulative incidence (%) Number at risk Triple therapy 284 Double therapy 279 Total number of TIMI bleeding events Triple-therapy group Double-therapy group Time (days) 44.4% 19.4% HR: 0.36 (95% CI: ) P< Death, MI, TVR, stroke, ST Triple-therapy group Double-therapy group HR: 0.60 (95% CI: ) P= % 11.1% Time (days) OAC + clopidogrel associated with significant reduction in TIMI bleeding events and no increase in thrombotic events vs triple therapy with OAC + clopidogrel + ASA Dewilde et al. Lancet 2013

10 WOEST trial Limitations Small number of patients (n=573) Not adequately powered for MACE < 25% received PCI for ACS 69% received VKAdue to AF 74% with femoral approach Differences in all bleeding driven by minor bleeding PPI not used routinely Dewilde WJM et al. The Lancet 2013.

11 Even when the duration of full dose TT was 6 weeks, a large percentage of the bleeding has already occurred.

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14 Baseline Characteristics Riva + P2Y 12 (N=709) Riva + DAPT (N=709) VKA + DAPT (N=706) Age, mean ± SD 70.4 ± ± ± 8.7 Sex, female, n (%) 181 (25.5%) 174 (24.5%) 188 (26.6%) Diabetes Mellitus, n (%) 204 (28.8%) 199 (28.1%) 221 (31.1%) Type of Index Event, n (%) NSTEMI 130 (18.5%) 129 (18.4%) 123 (17.8%) STEMI 86 (12.3%) 97 (13.8%) 74 (10.7%) Unstable Angina 145 (20.7%) 148 (21.1%) 164 (23.7%) Stable Angina 340 (48.5%) 329 (46.8%) 330 (47.8%) Drug-eluting stent, n (%) 464 (65.4%) 471 (66.8%) 468 (66.5%) Type of Atrial Fibrillation, n (%) Persistent 146 (20.6%) 146 (20.6%) 149 (21.1%) Permanent 262 (37.0%) 238 (33.6%) 243 (34.5%) Paroxysmal 300 (42.4%) 325 (45.8%) 313 (44.4%) Gibson et al. AHA 2016

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19 PIONEER substudy Time to all-cause death or first recurrent hospitalization Gibson CM et al. Circulation,2016.

20 The PIONEER AF-PCI trial PIONEER was not powered for efficacy

21 Safety Outcomes by Procedure and Lesion Characteristics and Treatment Group Kerneis M et al. JACC Cardiovasc Interv 2018.

22 Efficacy Outcomes by Procedure and Lesion Characteristics and Treatment Group Kerneis M et al. JACC Cardiovasc Interv 2018.

23 RE-DUAL PCI tested the safety and efficacy of two regimens of dual therapy with dabigatran without ASA vs triple therapy with warfarin Dabigatran 150 mg BID + P2Y12 inhibitor Patients with AF undergoing PCI with stenting R Dabigatran 110 mg BID + P2Y12 inhibitor Primary endpoint: ISTH major or CRNM bleeding N=2725 Randomization 120 hours post-pci* Warfarin (INR ) + P2Y12 inhibitor + ASA 6-month minimum treatment duration, maximum treatment duration 30 months (mean follow-up ~14 months) Cannon et al. Clin Cardiol 2016; Cannon et al. N Engl J Med 2017

24 Cannon et al. Clin Cardiol 2016; Cannon et al. N Engl J Med 2017

25 Cannon et al. Clin Cardiol 2016; Cannon et al. N Engl J Med 2017

26 Meta-Analyses of Results from Three Major Trials of Dual Therapy versus Triple Therapy Piccini JP, Schuyler Jones W. N Engl J Med 2017.

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32 Guidelines 2018 ESC/EACTS Guidelines on myocardial revascularization

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36 Management algorithm for AF patients presenting with elective PCI or ACS undergoing PCI Lip GYH et al. Europace 2018.

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38 Expert Consensus on Antithrombotic Management of Patients With AF Undergoing PCI A North American Perspective 2018 Update Angiolillo DJ et al. Circulation 2018.

39 Management of antiplatelet therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) treated with an oral anticoagulant (OAC): 2018 North American expert consensus update. Angiolillo DJ et al. Circulation 2018.

40 Unanswered questions Which antiplatelet agent shall we stop early: Aspirine or P2Y12 antagonist What is the place of new potent antiplatelet therapy (ticagrelor or prasugrel) in patients with stenting and AF Can we stop the last antiplatelet agent 1 year after PCI in AF patient on OAC Can we apply the same rules to valvural or TAVI patients Montalescot G. Eur Heart J 2018.

41 Major Randomized Trials Comparing Anticoagulation Strategies for Patients with Atrial Fibrillation Undergoing PCI Jolly SS. N Engl J Med, 2016.