Early or late intervention in highrisk non ST elevation acutecoronary syndromesresults of the ELISA-3 trialTrial reg: ISRC...
DisclosuresSpeakers name: Erik Badings I have the following potential conflicts of interest toreport: Consultancies Merck...
Background• Routine invasive strategy is treatment of choice inhigh risk patients with NSTE-ACS1• Controversy about optima...
Method• Multicentre, randomized study in 1 PCI and 5 non-PCI centres• Ischemic symptoms at rest < 24 h beforerandomisation...
MethodExclusion criteria:• Persistent ST-segment elevation• Ongoing ischemic symptoms despite optimal medicaltherapy• Cont...
Immediate treatment(angiography andrevascularisation <12h)n=269Delayed treatment(angiography andrevascularisation > 48h)n=...
Immediate (n=269) Delayed (n=265)Age (y;median, IQR) 72.1 (65.5-78.4) 71.8 (62.5-78.4)Male (%) 69.5 65.7Diabetes Mellitus ...
ResultsImmediate delayed P-valuePrimary endpoint(incid of death/ MI / rec. isch. 30d)9.9 % 14.2 % 0.135Death 1.1 % 1.1 % >...
Subgroup analysisOccurrence of primary endpoint in pre-specified subgroups
Occurrence of primary endpoint in post-hoc defined subgroupsSubgroup analysis
Comparison with meta analysisNavarese e.a. Ann Intern Med. 2013Katritsis e.a.Eur Heart J 2011MortalityMajor bleeding Recur...
Comparison with meta analysisNavarese e.a. Ann Intern Med. 2013Katritsis e.a.Eur Heart J 2011MortalityMajor bleeding Recur...
Limitations• Incidence of primary end point lower than expected(study underpowered)• Accurate assessment of periprocedural...
Conclusions• In this group of relatively old, high risk patients withNSTE-ACS early angiography and revascularisationwas n...
ELISA – 3
Early or late intervention in highrisk non ST elevation acutecoronary syndromesresults of the ELISA-3 trialTrial reg: ISRC...
Back-up slides
PCI vs. non-PCI centresPCI centren= 444Non-PCI centresn=90Immediate Delayed Immediate DelayedAge (y, median) 71.2 70.8 73....
Back-up slides
Death, MI, recurrent ischemia event free survival
Recurrent ischemia event free survival
ELISA 3: estrategia invasiva precoz vs tardía en pacientes sin supra desnivel del ST de alto riesgo
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ELISA 3: estrategia invasiva precoz vs tardía en pacientes sin supra desnivel del ST de alto riesgo

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Dr. Erik Badings. Congreso euroPCR 2013, París. Encuentre más presentaciones de este congreso en la página web oficial de SOLACI: www.solaci.org/

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ELISA 3: estrategia invasiva precoz vs tardía en pacientes sin supra desnivel del ST de alto riesgo

  1. 1. Early or late intervention in highrisk non ST elevation acutecoronary syndromesresults of the ELISA-3 trialTrial reg: ISRCTN39230163On behalf of the ELISA-3 InvestigatorsErik Badings, M.D, MSc epidemiologyDeventer Hospital, DeventerThe NetherlandsE.A. BadingsS.H.K. TheJ.H.E. DambrinkJ. van WijngaardenG. TjeerdsmaS. RasoulJ.R. TimmerM.L.J. van der WielenD.J.A. LokA.W.J. van’t Hof
  2. 2. DisclosuresSpeakers name: Erik Badings I have the following potential conflicts of interest toreport: Consultancies Merck Sharp & Dohme, Sanofi-Aventis
  3. 3. Background• Routine invasive strategy is treatment of choice inhigh risk patients with NSTE-ACS1• Controversy about optimal timing of intervention• Meta analysis2: early intervention modest benefitdue to significant reduction recurrent ischemia• Age in trials is lower than in NSTE-ACS patients in reallife (68 y): generalizability questionable1ESC guidelines NSTE-ACS . Eur Heart J. 2011;32:2999-30542Katritsis e.a Eur Heart J. 2011;32-40
  4. 4. Method• Multicentre, randomized study in 1 PCI and 5 non-PCI centres• Ischemic symptoms at rest < 24 h beforerandomisation plus at least 2 out of 3 high riskcharacteristics:– Extensive myocardial ischemia (> 5 mm cum. ST depressionor temporary ST elevation < 30 min.)– Positive biomarkers (Troponin T > 10µg/l, Myoglobin >150µg/l or CK-MB fraction > 6%)– Age > 65 years
  5. 5. MethodExclusion criteria:• Persistent ST-segment elevation• Ongoing ischemic symptoms despite optimal medicaltherapy• Contra-indication for angiography• Active bleeding• Cardiogenic shock• Acute posterior infarction• Life expectancy < 1 year
  6. 6. Immediate treatment(angiography andrevascularisation <12h)n=269Delayed treatment(angiography andrevascularisation > 48h)n=265 Primary Endpoint: Death /re-MI /recurrent ischemia 30 d Secondary endpoints: Enzymatic infarct size (TropT 72-96 h after admissionor at discharge) % without CK-MB rise during admissionn=542Method
  7. 7. Immediate (n=269) Delayed (n=265)Age (y;median, IQR) 72.1 (65.5-78.4) 71.8 (62.5-78.4)Male (%) 69.5 65.7Diabetes Mellitus (%) 23.8 20.4Previous MI (%) 17.8 19.6GRACE Risk Score (med, IQR) 136 (118-154) 133 (117-154)Biomarker positive* (%) 78.4 79.2Multivessel disease (%) 62.2 62.1Time admission- randomisation(h; median, IQR)2.0 (0.9 - 4.5) 2.1 (1.0 – 4.2)Time randomisation -angio(h; median, IQR)2.6 (1.2 – 6.2) 54.9 (44.2-74.5)Baseline and angiographic data* Pos Trop (>0.10 µg/l), Myoglobin (>150 µg/l) or pos CK-mb (> 6%)
  8. 8. ResultsImmediate delayed P-valuePrimary endpoint(incid of death/ MI / rec. isch. 30d)9.9 % 14.2 % 0.135Death 1.1 % 1.1 % > 0.99MI (%) 1.9 % 0.8 % 0.450Recurrent ischemia (%) 7.6 % 12.6 % 0.058Secondary endpointsEnzymatic infarct size (TropT72-96 h (median,IQR)0.31 µg/l(0.12-0.68)0.31 µg/l(0.10-0.99)0.983% without CK-MB rise 35.4 % 36.5 % 0.801SafetyAny Bleeding 22.9 % 19.9 % 0.407Major Bleed 11.8 % 11.1 % 0.796Hospital stay (d, median IQR) 4.0 (2.0-10.0) 6.0 (4.0-12.0) <0.001
  9. 9. Subgroup analysisOccurrence of primary endpoint in pre-specified subgroups
  10. 10. Occurrence of primary endpoint in post-hoc defined subgroupsSubgroup analysis
  11. 11. Comparison with meta analysisNavarese e.a. Ann Intern Med. 2013Katritsis e.a.Eur Heart J 2011MortalityMajor bleeding Recurrent ischemiaMyocardial infarction
  12. 12. Comparison with meta analysisNavarese e.a. Ann Intern Med. 2013Katritsis e.a.Eur Heart J 2011MortalityMajor bleeding Recurrent ischemiaMyocardial infarction
  13. 13. Limitations• Incidence of primary end point lower than expected(study underpowered)• Accurate assessment of periprocedural MI’s isdifficult in patients with elevated biomarkers
  14. 14. Conclusions• In this group of relatively old, high risk patients withNSTE-ACS early angiography and revascularisationwas not superior to a delayed invasive strategy• Results consistent with trials and meta-analyses:early invasive strategy:– Trend towards more benefit in higher risk patients– Hospital stay significantly shorter• Patients included in non-PCI centres seem to benefitmore from early intervention: further investigationneeded
  15. 15. ELISA – 3
  16. 16. Early or late intervention in highrisk non ST elevation acutecoronary syndromesresults of the ELISA-3 trialTrial reg: ISRCTN39230163On behalf of the ELISA-3 InvestigatorsErik Badings, M.D.Deventer Hospital, DeventerThe NetherlandsE.A. BadingsS.H.K. TheJ.H.E. DambrinkJ. van WijngaardenG. TjeerdsmaS. RasoulJ.R. TimmerM.L.J. van der WielenD.J.A. LokA.W.J. van’t Hof
  17. 17. Back-up slides
  18. 18. PCI vs. non-PCI centresPCI centren= 444Non-PCI centresn=90Immediate Delayed Immediate DelayedAge (y, median) 71.2 70.8 73.8 73.0GRACE Risk Score (med) 136 135 136 130Biomarker positive (%) 81.7 82.3 62.2 64.4Multivessel disease (%) 63.6 61.2 54.5 66.7Time admission-randomisation(h;median, IQR)2.0(1.1-4.2)2.2(1.2-3.9)2.8(0.5-5.8)1.9(0.5-9.1)Time randomisation – angio(h;median, IQR)2.6(1.1-6.7)53.1 (43.5-71.9)3.0 (2.2-4.0)70.1 (50.6-112.6)Time angio – revascularisation(h;median, IQR)0.40(0.21-24.8)0.53(.25-48.5)0.71(0.29-63.7146(82.0-297)% of patients treated with PCI 59.8 55.5 52.3 41.9
  19. 19. Back-up slides
  20. 20. Death, MI, recurrent ischemia event free survival
  21. 21. Recurrent ischemia event free survival

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