SCA ST- : recommandations européennes 2015 La durée de la bithérapie : à géométrie variable?

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1 SCA ST- : recommandations européennes 2015 La durée de la bithérapie : à géométrie variable? tielle est 2 ré Totielle est interdite. Prof. Marco Roffi Hôpitaux Universitaires de Genève

2 Research funding Conflicts of Interest Abbott vascular Biotronik Biosensor Medtronic tielle est 2 ré Totielle est interdite. Boston Scientific Speaker fees (related to NSTEMI GL) Astra Zeneca

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4 Recommendations for platelet inhibition in NSTE-ACS Recommendations Oral antiplatelet therapy Aspirin is recommended for all patients without contra-indications at an initial oral loading dose c of mg (in aspirin-naïve patients) and a maintenance dose of mg daily long-term regardless of treatment strategy. A P2Y 12 inhibitor is recommended, in addition to aspirin, for 12 months unless there are contraindications such as excessive risk of bleeds. Ticagrelor (180 mg loading dose, 90 mg twice daily) is recommended, in the absence of contraindications d, for all patients at moderate- to high-risk of ischaemic events (e.g. elevated cardiac troponins), regardless of initial treatment strategy and including those pretreated with clopidogrel (which should be discontinued when ticagrelor is started). tielle est 2 ré Totielle est interdite. Prasugrel (60 mg loading dose, 10 mg daily dose) is recommended in patients who are proceeding to PCI if no contraindication. d Clopidogrel ( mg loading dose, 75 mg daily dose) is recommended for patients who cannot receive ticagrelor or prasugrel or who require oral anticoagulation. P2Y 12 inhibitor administration for a shorter duration of 3 6 months after DES implantation may be considered in patients deemed at high bleeding risk. It is not recommended to administer prasugrel in patients in whom coronary anatomy is not known. Class ACCOAST I I I I I IIb III a Leve A A B B B A B l b

5 Recommendations for platelet inhibition in NSTE-ACS (continued) Recommendations Class a Level b Long-term P2Y 12 inhibition tielle est 2 ré Totielle est interdite. P2Y 12 inhibitor administration in addition to aspirin beyond 1 year may be considered after careful assessment of the ischaemic and bleeding risks of the patient. General recommendations A proton pump inhibitor in combination with DAPT is recommended in patients at higher than average risk of gastrointestinal bleeds (i.e. with a history of gastrointestinal ulcer/haemorrhage, anticoagulant therapy, chronic NSAID/corticosteroid use or two or more among age 65 years, dyspepsia, gastro-oesophageal reflux disease, Helicobacter pylori infection, and chronic alcohol use). IIb I A B

6 DAPT Duration after PCI with DES: Meta-analysis of RCT CV Mortality tielle est 2 ré Totielle est interdite. MI Navarese et al, BMJ 2015;350:h1618 Short term vs 12 month Extended vs 12 month

7 DAPT Duration after PCI with DES: Meta-analysis of RCT Navarese et al, BMJ 2015;350:h1618 Major Bleeding tielle est 2 ré Totielle est interdite.

8 META-ANALYSIS OF TRIALS EVALUATING PROLONGED DAPT FOLLOWING MI Trial CHARISMA Subgroup /Population Stable prior MI (mean 24 mo.) N Drug Duration (months) MACE Events 3846 Clopi Bleeding EP GUSTO mod/severe PRODIGY PCI for ACS 1465 Clopi 6 vs TIMI major ARCTIC- Interruption PCI for ACS (excluded STEMI) 323 DAPT PCI for MI 3576 Clopi or Pras Clopi or Pras 12 vs vs tielle est 2 ré Totielle est interdite. STEEPLE major GUSTO mod/severe DES-Late PCI for ACS 3063 Clopi 12 vs TIMI major PEGASUS TIMI-54 Stable prior MI (median 20 mo.) Ticag TIMI major Total Abbreviations: Clopi: clopidogrel; Pras: prasugrel; Ticag: ticagrelor EHJ 2015 J. Udell (Toronto, CA) FP3913

9 META-ANALYSIS: INDIVIDUAL CV AND BLEEDING ENDPOINTS Event Rate (%) Event Rate (%) EHJ 2015 HR 0.78 P = ,5 6,4 HR 1.73 P = ,9 1,1 HR 0.85 P = ,3 2,6 MACE CV Death MI Stroke Stent Thrombosis (Def/Prob) P = NS P = NS 0,4 0,3 0,1 0,2 Extended DAPT 1,7 1,6 Aspirin Alone HR 0.70 P = HR ,4 P = 0.02 HR ,5 P = ,4 1,7 1,4 0,6 tielle est 2 ré Totielle est interdite. HR 1.05 P = NS HR 0.92 P = NS 4,0 4,2 Major Bleeding ICH Fatal Bleeding Non-CV Death All-Cause Death J. Udell (Toronto, CA) FP 3913

10 ACS 27% DAPT Duration and Drug-Eluting Stents LEADERS FREE Trial Prospective, double-blind randomized (1:1) trial 2466 High bleeding risk (HBR) PCI patients BioFreedom DCS vs. Gazelle BMS DAPT mandated for 1 month only, followed by long-term SAPT tielle est 2 ré Totielle est interdite. Primary safety endpoint: Composite of cardiac death, MI, definite / probable stent thrombosis at 1 year (non-inferiority then superiority) Primary efficacy endpoint: Clinically-driven TLR at 1 year (superiority) P. Urban, NEJM online

11 Primary Efficacy Endpoint (Clinically-Driven TLR) Cumulative Percentage with Event Number at Risk % tielle est 2 ré Totielle est interdite. 0 0 p for superiority < DCS BMS % 5.1% Days 390 days chosen for assessing primary EP to capture potential evens driven by the 360 day FU contact P. Urban, NEJM online

12 Primary Safety Endpoint (Cardiac Death, MI, ST) Cumulative Percentage with Event Number at Risk % p = for superiority tielle est 2 ré Totielle est interdite DCS BMS % 9.4% Days 390 days chosen for assessing primary EP to capture potential events driven by the 360 day FU contact P. Urban, NEJM online

13 % ,2 Components of Safety Endpoint DCS 5,3 BMS tielle est 2 ré Totielle est interdite. 6,1 Cardiac death MI ST (def / prob) p = 0.19 p = 0.01 p = ,9 2,0 2,2

14 Management strategy Bleeding risk Time from PCI/ACS 0 4 weeks 6 months 12 months Lifelong NSTE-ACS patients with non-valvular atrial fibrillation Low to intermediate (e.g. HAS-BLED = 0 2) Triple therapy O A C Dual therapy b O C or A PCI High (e.g. HAS-BLED 3) O Triple or dual therapy a O A C Dual therapy b Monotherapy c Oral anticoagulation O A ASA mg daily C (VKA or NOACs) O Medically managed /CABG Dual therapy b Clopidogrel 75 mg daily a Dual therapy with OAC and and clopidogrel may be considered in selected patients (low ischaemic risk). b aspirin as an alternative to clopidogrel may be considered in patients on dual therapy (i.e., oral anticoagulation plus single antiplatelet) Triple therapy may be considered up to 12 months in patients at very high risk for ischaemic events. c Dual therapy with oral anticoagulation and an antiplatelet agent (aspirin or clopidogrel) beyond one year may be considered in patients at very high risk of coronary events. In patients undergoing coronary stenting, dual antiplatelet therapy may be an alternative to triple or dual therapy if the CHA2DS2-VASc score is 1 (males) or 2 (females). C or A tielle est 2 ré Totielle est interdite. DES DES/BMS? O C or A

15 SCA ST- : recommandations européennes 2015 La durée de la bithérapie : à géométrie variable? 12 month DAPT remains the standard for the majority of patients In selected patients at high risk for ischemic / bleeding events, shorter or longer DAPT duration may be considered Consequences of the major reduction in stent thrombosis observed with newer generation DES 1. DAPT duration as short as one month possible 2. Prolonged DAPT aimed more at prevention of events related to CAD progression than very late stent thromboses tielle est 2 ré Totielle est interdite. if you want to know more about antithrombotic treatment in tricky situations

16 40 cases each No reference Link to the dedicated sections of the GL Help to implement GL in daily practice European Heart Journal doi: /eurheartj/ehv409 tielle est 2 ré Totielle est interdite. European Heart Journal doi: /eurheartj/ehv407 European Heart Journal doi: /eurheartj/ehv408 16