Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Pacientes con FA que sufren un SCA
y son sometidos...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
AF and PCI
 Background and epidemiology
 Current...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
@ 1 Billion people in US and Europe
@ 20 Million w...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Atrial Fibrillation (ACTIVE W)1: The
combination o...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
2007 Guidelines recommended
Prolonged Triple Thera...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Crudeincidencerates
(eventsper100person-years±SE)
...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Kirchhof P, et al. 2016 ESC Guidelines for the man...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
2016 ESC/EHRA/ESO Guidelines for AF
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
2016 ESC/EHRA/ESO Guidelines for AF
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
AF and PCI
 Background and epidemiology
 Current...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
AF and PCI: gaps in evidence
 NOAC lowest effecti...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Dose of Rivaroxaban Varies in ACS &
Atrial Fibrill...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Patient populations Supporting evidence
Patients w...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Per-protocol population on-treatment; The study wa...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Per-protocol population on-treatment; Analysis met...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
• Small-scale, open-label WOEST study (N=573) comp...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
AF and PCI
 Background and epidemiology
 Current...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
1. Kirchhof P et al, Eur Heart J 2016; doi:10.1093...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
*CrCl 30–49 ml/min: 10 mg OD; #first dose 72–96 ho...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
1. Dewilde WJ et al, Lancet 2013;381:1107–1115; 2....
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
PIONEER AF-PCI
Rationale for Anticoagulant Dose Se...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
PIONEER AF-PCI
Rationale for Selection of ASA or P...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Endpoint Analysis period Analysis set
Primary safe...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Key inclusion
criteria
Key exclusion
criteria
 Me...
Novedades en el manejo del paciente con FA: actualización tras AHA 2016
Remarks
 OAC are needed for preventing stroke.
 ...
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Pacientes con FA que sufren un SCA y son sometidos a intervención coronaria percutánea. Guías y preguntas abiertas

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Novedades en el manejo del paciente con FA: actualización tras AHA 2016
22/11/2016 19:30h Casa del Corazón, Madrid
http://manejofa.secardiologia.es
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Pacientes con FA que sufren un SCA y son sometidos a intervención coronaria percutánea. Guías y preguntas abiertas
Dr. Antonio Fernández Ortiz, Hospital Universitario Clínico San Carlos (Madrid)

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Pacientes con FA que sufren un SCA y son sometidos a intervención coronaria percutánea. Guías y preguntas abiertas

  1. 1. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Pacientes con FA que sufren un SCA y son sometidos a intervención coronaria percutánea: guías y preguntas abiertas Antonio Fernández-Ortiz Hospital Clínico San Carlos
  2. 2. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 AF and PCI  Background and epidemiology  Current guidelines for management  Gaps in evidence ( i.e NOACs)  Rationale and design PIONEER
  3. 3. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 @ 1 Billion people in US and Europe @ 20 Million with AF (1-2% of population)1,2 @ 16 Million anticoagulation indicated (80%) 1,2 @ 4.8 Million have CAD as well (20%-45%)1,2 @ 1- 2 Million potential revasc (20%-25%) 3,4 1. The AFFIRM Investigators. Am Heart J 2002;143:991–1001; 2. Carpodanno D et al, Circ Cardiovasc Interv 2014;7:113–124; 3. Kralev S et al, PLoS One 2011;6:e24964; 4. Bahit MC et al, Int J Cardiol 2013;170:215–220 AF and CAD often occur together because of the strong association of both conditions with aging and overlapping risk factors 24.9% of patients with AF enrolled in ARISTOTLE had prior PCI4 Gibson et al. AHA 2016 Epidemiology: AF and PCI
  4. 4. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Atrial Fibrillation (ACTIVE W)1: The combination of aspirin and clopidogrel is not as effective as warfarin in patients with AF1 However Stenting (STARS)2: The combination of aspirin and a thienopyridine is more effective than warfarin in patients with coronary stents 2 1. Lancet 2006 Jun 10;367(9526):1903-12. 2. N Eng J Med 1998 Dec 3;339(23):1665-71. The Optimal Management of AF and ACS Differ Gibson et al. AHA 2016
  5. 5. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 2007 Guidelines recommended Prolonged Triple Therapy ACC/AHA 2007 Guidelines for management of patients with NSTE-ACS UA/NSTEMI patient groups at discharge with indication for anticoagulation Bare-metal stent group ASA*  162–325 mg/day for at least 1 month, then 75– 162 mg/day indefinitely Clopidogrel#  75 mg/day for at least 1 month and ideally up to 1 year Warfarin‡  When added to ASA plus clopidogrel an INR of 2.0–2.5 is recommended Drug-eluting stent group ASA*  162–325 mg/day for at least 3–6 months, then 75–162 mg/day indefinitely Clopidogrel#  75 mg/day for at least 1 year Warfarin‡  When added to ASA plus clopidogrel an INR of 2.0–2.5 is recommended *For ASA allergic patients, use clopidogrel alone (indefinitely), or try desensitization; #for clopidogrel allergic patients, use ticlopidine 250 mg by mouth twice daily; ‡continue ASA indefinitely and warfarin longer term as indicated for specific conditions such as AF Anderson JL et al, Circulation 2007;116:e148–e304
  6. 6. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Crudeincidencerates (eventsper100person-years±SE) CV death plus MI plus ischaemic stroke Fatal and non-fatal bleeding 0 10 20 30 40 Triple therapy (VKA plus ASA plus clopidogrel) VKA plus single antiplatelet therapy DAPT (ASA plus clopidogrel) VKA monotherapy Single antiplatelet therapy Triple Therapy with a VKA Reduces Thromboembolic Events but Increases Bleeding after PCI in AF Patients Danish registry data (2000–2009; N=11,480 patients) Lamberts M et al, Circulation 2012;126:1185–1193
  7. 7. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Kirchhof P, et al. 2016 ESC Guidelines for the management of AF. EHJ doi:10.1093/eurheartj/ehw210 2016 ESC/EHRA/ESO Guidelines for AF
  8. 8. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 2016 ESC/EHRA/ESO Guidelines for AF
  9. 9. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 2016 ESC/EHRA/ESO Guidelines for AF
  10. 10. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 AF and PCI  Background and epidemiology  Current guidelines for management  Gaps in evidence ( i.e NOACs)  Rationale and design PIONEER
  11. 11. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 AF and PCI: gaps in evidence  NOAC lowest effective dose for stroke prevention?  Omission of aspirin while maintaining a P2Y12 inh.?  Safety of tica/prasu as part of combination therapy?  Duration of triple/dual combination therapy?
  12. 12. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Dose of Rivaroxaban Varies in ACS & Atrial Fibrillation Patients ACS/ Stenting Atrial Fibrillation Stent + Afib DAPT + 2.5 mg BID Riva Riva 20 mg QD 4 Fold Difference in Riva Dose Between ACS and AF 1. Schmitt J et al Atrial fibrillation in acute myocardial infarction: a systematic review of the incidence, clinical features and prognostic implications. Eur Heart J 2009;30:1038–1045. Gibson et al. AHA 2016
  13. 13. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Patient populations Supporting evidence Patients with moderate renal impairment (CrCl 30-49 ml/min) ROCKET-AF1 n=1,474  XANTUS2 n=1,410  PMSS3 n=6,034*  Japanese patients J-ROCKET4 n=639  XAPASS5 n=4,909  Patients undergoing PCI# PIONEER AF-PCI6 n=696  1. Fox KAA et al, Eur Heart J 2011;32:2387–2394; 2. Camm AJ et al, Eur Heart J 2016;37:1145–1153 3. Tamayo S et al. Circulation. 2015 (132 Suppl 3); 4. Hori M et al. Circ J 2012; 76: 2104 – 2111 5. Ikeda T et al, presented at ESC 2016: 2953. Available at: http://congress365.escardio.org 6. Gibson CM et al, New Engl J Med 2016; doi: 10.1056/NEJMoa1611594 *Patients with renal dysfunction (as surrogate) #The tested dosing regimens with rivaroxaban in PIONEER AF-PCI are currently not approved The reduced dose of Rivaroxaban 15 mg OD was also studied in the Phase IIIb RCT J-ROCKET AF
  14. 14. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Per-protocol population on-treatment; The study was not powered to test efficacy hypotheses Hori M et al, Circ J 2012;76:2104–2111 Endpoints HR 95% CI HR (95% CI) p-value Principal Safety Outcome Major or non-major clinically relevant bleeding 1.11 0.87–1.42 <0.001 (non-inferiority) Major bleeding 0.85 0.50–1.43 N.S. Non-major clinically relevant bleeding 1.20 0.92–1.56 N.S. Primary Efficacy Endpoint Stroke/Systemic Embolism 0.49 0.24–1.00 0.050 All cause stroke 0.46 0.22–0.98 Not reportedPrimary hemorrhagic stroke 0.73 0.16–3.25 Primary ischemic stroke 0.40 0.17–0.96 0,1 1 10 Rivaroxaban 15 mg OD in the Phase IIIb RCT J-ROCKET AF
  15. 15. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Per-protocol population on-treatment; Analysis method: Cox proportional hazard model Hori M et al, Circ J 2012;76:2104–2111 Number of patients at risk: Rivaroxaban 637 593 563 542 443 313 217 156 48 0 Warfarin 637 581 547 517 406 285 212 154 48 0 Rivaroxaban 15 mg OD in the Phase IIIb RCT J-ROCKET AF Event rate (%/year) Rivaroxaban Warfarin Stroke/SE 1.26 2.61 Days since randomization Cumulativeeventrate timetofirstevent(%) 0 100 200 300 400 500 600 700 800 900 Warfarin HR=0.49 (95% CI 0.24–1.00) p=0.050 (two-sided test) Rivaroxaban 0 1 2 3 4 5 6 7
  16. 16. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 • Small-scale, open-label WOEST study (N=573) compared safety outcomes with triple therapy (VKA plus clopidogrel plus ASA) vs dual therapy (VKA plus clopidogrel): 69% of WOEST patients had AF 0 10 20 30 40 50 Any bleeding TIMI major TIMI major + minor Cumulativeincidence(%) * * *p<0.05 Dewilde WJ et al, Lancet 2013;381:1107–1115 Use of dual therapy was associated with significantly lower rates of bleeding and overall mortality vs triple therapy, with similar rates of thrombotic events * 0 10 20 30 40 50 Death MI Stroke Cumulativeincidence(%) Safety outcomes Efficacy outcomes VKA plus clopidogrel (dual therapy) (n=279) VKA plus clopidogrel plus ASA (triple therapy) (n=284) 23% 14% 31% Power The WOEST trial: is ASA necessary in triple therapy?
  17. 17. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 AF and PCI  Background and epidemiology  Current guidelines for management  Gaps in evidence ( i.e NOACs)  Rationale and design PIONEER
  18. 18. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 1. Kirchhof P et al, Eur Heart J 2016; doi:10.1093/eurheartj/ehw210; 2. Amsterdam EA et al, Circulation 2014;130:e344–e426; 3. Sørensen R et al, Lancet 2009;374:1967–1974; 4. Gibson CM et al, Am Heart J 2015;169:472–478e5 PIONEER AF-PCI Study Rationale and Objective Rationale Objective  Patients with AF after PCI are indicated for both oral anticoagulation and antiplatelet therapy1,2  However, combining a VKA with antiplatelet therapy is associated with an increased risk of serious bleeding episodes3  There is currently a lack of evidence to support clinical guidelines  To assess the safety of two rivaroxaban treatment strategies compared with the current standard of care in patients with paroxysmal, persistent or permanent NVAF undergoing PCI with stent placement4
  19. 19. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 *CrCl 30–49 ml/min: 10 mg OD; #first dose 72–96 hours after sheath removal; ‡clopidogrel (75 mg daily) (alternative use of prasugrel or ticagrelor allowed, but capped at 15%); §ASA (75–100 mg daily) plus clopidogrel (75 mg daily) (alternative use of prasugrel or ticagrelor allowed, but capped at 15%); ¶first dose 12–72 hours after sheath removal 1. Janssen Scientific Affairs, LLC. 2016. https://clinicaltrials.gov/ct2/show/NCT01830543 [accessed 10 Oct 2016]; 2. Gibson CM et al, Am Heart J 2015;169:472–478e5; 3. Gibson CM et al, New Engl J Med 2016; doi: 10.1056/NEJMoa1611594 An open-label, randomized, controlled phase IIIb safety study Rivaroxaban 15 mg OD*# plus single antiplatelet‡ End of treatment (12 months) Rivaroxaban 2.5 mg BID# plus DAPT§ VKA (INR 2.0–3.0)¶ plus DAPT§ Rivaroxaban 15 mg OD* plus low-dose ASA VKA plus low-dose ASA N=2,124 1:1:1 Population: patients with paroxysmal, persistent or permanent NVAF undergoing PCI (with stent placement) R Decision for DAPT duration: 1, 6 or 12 months DAPT duration (1 or 6 months) PIONEER AF-PCI Study design
  20. 20. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 1. Dewilde WJ et al, Lancet 2013;381:1107–1115; 2. Amsterdam EA et al, Circulation 2014;130:e344–e426; 3. O’Gara PT et al, J Am Coll Cardiol 2013;61:e78–e140; 4. Kirchhof P et al, Eur Heart J 2016; doi:10.1093/eurheartj/ehw210; 5. Heidbuchel H et al, Europace 2015;17:1467–1507 PIONEER AF-PCI Rationale for Dual and Triple Therapy Arms Study group 1 Study group 2 Study group 3 Rivaroxaban 15 mg OD plus P2Y12 Rivaroxaban 2.5 mg BID plus ASA plus P2Y12 Rivaroxaban 15 mg OD plus ASA VKA plus ASA plus P2Y12 VKA plus ASA Where US guidelines recommend triple therapy with a VKA,2,3 recent European guidelines suggest that a NOAC may be used in triple and dual therapy after PCI4,5 Triple therapy with a VKA plus DAPT followed by dual therapy with VKA plus ASA is the standard of care for patients with AF and ACS, as recommended by US guidelines2,3 The WOEST study showed oral anticoagulation in combination with clopidogrel was associated with significantly lower bleeding than triple therapy with no increase in thrombotic events1 This strategy has not yet been tested in a large study 12 months 1, 6 or 12 months Up to 12 months 1, 6 or 12 months Up to 12 months
  21. 21. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 PIONEER AF-PCI Rationale for Anticoagulant Dose Selection Study group 1 Study group 2 Study group 3 Rivaroxaban 15 mg OD plus P2Y12 Rivaroxaban 2.5 mg BID plus ASA plus P2Y12 Rivaroxaban 15 mg OD plus ASA VKA plus ASA plus P2Y12 VKA plus ASA The safety of the rivaroxaban 2.5 mg BID dose in combination with DAPT was demonstrated in the ATLAS ACS 2 TIMI 51 trial3 A target INR of 2.0–3.0 was selected because this is the recommended INR for stroke prevention in patients with AF4 ATLAS ACS TIMI 46: rivaroxaban 15 mg OD was associated with lower bleeding rates than 20 mg OD when taken in combination with antiplatelets1 J-ROCKET AF: rivaroxaban 15 mg OD showed similar efficacy and safety compared with warfarin, with a trend towards a lower incidence of stroke/SE2 12 months 1, 6 or 12 months Up to 12 months 1, 6 or 12 months Up to 12 months 1. Mega JL et al, Lancet 2009;374:29–38; 2. Hori M et al, Circ J 2012;76:2104–2111; 3. Mega JL et al, N Engl J Med 2012;366:9–19; 4. Kirchhof P et al, Eur Heart J 2016; doi:10.1093/eurheartj/ehw210
  22. 22. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 PIONEER AF-PCI Rationale for Selection of ASA or P2Y12 Inhibitor Study group 1 Study group 2 Study group 3 Rivaroxaban 15 mg OD plus P2Y12 Rivaroxaban 2.5 mg BID plus ASA plus P2Y12 Rivaroxaban 15 mg OD plus ASA VKA plus ASA plus P2Y12 VKA plus ASA In Groups 2 and 3, a period of triple therapy was followed by dual therapy using an OAC plus low-dose ASA. ASA was selected over clopidogrel because it is used for long-term therapy after PCI (guidelines from the ACCF/AHA/SCAI for the management of PCI recommend continuing therapy with ASA indefinitely)4 WOEST showed that combining an OAC (VKA) and clopidogrel was safe and effective1 Prasugrel and ticagrelor were permitted at the discretion of the investigator as they are recommended in ACS guidelines2,3 12 months 1, 6 or 12 months Up to 12 months 1, 6 or 12 months Up to 12 months 1. Dewilde WJ et al, Lancet 2013;381:1107–1115; 2. Steg PG et al, Eur Heart J 2012;33:2569–2619; 3. Roffi M et al, Eur Heart J 2016;37:267–315; 4. Levine GN et al, Circulation 2011;124:e574–e651
  23. 23. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Endpoint Analysis period Analysis set Primary safety endpoint Clinically significant bleeding (major bleeding, minor bleeding or bleeding requiring medical attention*) Treatment-emergent period# (primary) Post-randomization period (supportive) Safety analysis set‡ Secondary endpoints Components of the primary safety endpoint Treatment-emergent period# Safety analysis set‡ Composite of a major adverse CV event (MI, stroke or CV death) Treatment-emergent period# Safety analysis set‡ Components of a major adverse CV event or stent thrombosis Treatment-emergent period# Safety analysis set‡ *Bleeding events were classified according to the TIMI scale; #the treatment-emergent period was the time from the first study drug administration up to 2 days after drug discontinuation; ‡the safety analysis set consisted of all randomized patients who received at least one dose of study drug Gibson CM et al, Am Heart J 2015;169:472–478e5 PIONEER AF-PCI Primary and Secondary Endpoints
  24. 24. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Key inclusion criteria Key exclusion criteria  Medical history of paroxysmal, persistent or permanent NVAF  Undergone PCI with stent placement for primary atherosclerotic disease  INR ≤2.5 at randomization *Including, but not limited to, platelet count <90,000/µl at screening, history of ICH, 12-month history of clinically significant GI bleeding, non-VKA-induced elevated PT at screening, anaemia of unknown cause with a haemoglobin level <10 g/dl (<6.21 mmol/l) or significant liver disease or liver function test abnormalities Janssen Scientific Affairs, LLC. 2016. https://clinicaltrials.gov/ct2/show/NCT01830543 [accessed 14 Oct 2016]  Contraindication for anticoagulant or antiplatelet therapy or unacceptable risk of bleeding*  History of stroke or TIA  CrCl <30 ml/min at screening PIONEER AF-PCI Key inclusion and exclusion criteria
  25. 25. Novedades en el manejo del paciente con FA: actualización tras AHA 2016 Remarks  OAC are needed for preventing stroke.  Antiplatelet drugs are needed for preventing ST.  Combining OAC and APT increases bleeding.  Therefore, there is a need to clarify the optimal combination regimen in terms of choice of agents, dose and duration.  PIONEER AF-PCI is the first RCT to address this issue with NOACs.  Given the safety and convenience advantages of Rivaroxaban over VKA, this is of paramount importance. In AF and PCI, these are the facts:

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