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~ 15000 in-hospital STEMI / year

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~ 15000 in-hospital STEMI / year

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  1. STEMI - Romania2009 - 2013.G P. Tatu-Chițoiu, Arafat R, D. Deleanu,A. Petriș, A. Diaconeasa, C. Udroiu, C. Arsenescu-Georgescu, K. Babeș, I. Benedek, E. Bobescu, R. Căpâlneanu, M. Dorobanțu, D. Olinic, F. Orțan, I. Parepa, L. Petrescu, C. Pop, I. Țilea, D. Vinereanuon behalf of the RO-STEMI registry investigators

  2. ~ 15000 in-hospital STEMI / year

  3. ROMANIA: Building the National STEMI network Competency in Interventional Cardiology On duty paied lines 2011 National Health House budget for medication Specific state budget PCI STEMI 1000 Euro/PCI 2010 National program for interventional STEMI treatment RO-STEMI registry Pre-hospital STEMI guidelines 2009 2008 10 Cathlabs Emergency rooms SMURD

  4. Timisoara Romanian STEMI network – on August 1st, 2010 Asp+Clop+UH=> PPCI Iasi Cluj Tg. Mures Bucuresti Romanian STEMI network – on August 1st, 2010

  5. Timisoara Brasov Oradea Constanta Romanian STEMI network – on December 31st, 2013 Asp+Clop+UH=> PPCI Thrombolysis +Asp+Clop+UH=> PCI Baia Mare Suceava Iasi Cluj Tg. Mures Bucuresti

  6. Romanian RO-STEMI registry (1.01.1997 – 31.12.2013) Sponsored by ASTRA - ZENECA from 2012 The in-hospital mortality data: 50476 patients Demographic & treatment, data: ~ 35 000 patients 2010 – 2013: data on mortality from 30966 patients

  7. RO-STEMI registry: Percentage of STEMI patients treated with PCI, thrombolysis and conventional therapy in Romania between 2003 - 2013 PCI network 63.35% 2013 No reperfusion Post poned 11.23% 4.53% Rescue T-lysis 47.59% PPCI 31.12% PCI 5.29%

  8. RO-STEMI registry: In-hospital mortality in STEMI patients between 2009 - 2013 13.5% 12.2% 9.93% 8.19% 8.38%

  9. Global in-hospital mortality in STEMI patients in Romania (2013) and other European countries (2010 – 2011) 2009 2010 2011 2012, 2013 Data from PCI treated patients only Widimski et al. in press

  10. Rates of reperfusion procedures and the in-hospital mortality (2012-2013) in the 8 regions of economic development of Romania 6. 1. 73,05% 66,24% 8,27% 8,06% 7. 5. 53,86% 55,04% 10,83% 2. 10,10% 41,05% 4. 9,66% 3. 22,85% 21,45% 8. 10,71% 81,35% 11,76% 4,29%

  11. C O N C L U S I O N S(RO-STEMI registry 2009 - 2013) 1. 2009 – 2013: 150% increase of the PCI treated pts. 2.a national STEMI network, based on limited number of PCI 24/7 centers but a large scale of pharmaco-invasive approach resulted in a 40% decrease of the in-hospital mortality . 3. The lowest in-hospital mortality = in pharmacoinvasive treated patients 4. But: - unbalanced distribution of the reperfusion procedures => unbalanced impact on mortality

  12. What should we do in the next future ? • Consolidate old cath labs • New cath labs • Increase number of interventionists • Encourage pharmaco-invasive approach

  13. Timisoara Brasov Oradea Constanta Romanian STEMI network – on December 31st, 2013 Baia Mare Suceava Iasi Cluj Tg. Mures Bucuresti

  14. Timisoara Brasov Oradea Constanta Romanian STEMI network – on July 1st, 2014 Baia Mare Suceava Iasi Cluj Tg. Mures Braila Ploiesti Bucuresti

  15. Timisoara Brasov Oradea Constanta Romanian STEMI network – in 2020 ??? Baia Mare Suceava Iasi Cluj Tg. Mures Bacau Sibiu Buzau Braila Ploiesti Craiova Bucuresti

  16. RO-STEMI registry: In-hospital mortality in STEMI patients according with therapy 2012 & 2013 14.99% N=17493 Global mortality: 8.31% 8.81% N=5954 p= 0.001 5,69% 4.35% N=1362 3.48% N=650 N=7994 N=1478 Postponed PPCI Rescue T – lysis No reperf. PCI PCI

  17. RO – STEMI registry data (2010 – 2013) • At least 60 % of STEMI patients receiving thrombolysis clopidogrel, aspirin and unfractionated heparin and • 35% of patients receiving only clopidogrel, aspirin and unfractionated heparin before their transfer arrived to the PCI center with a TIMI 2/3 flow on the culprit artery.

  18. Ticagrelor in the hospital phase of STEMI ? ONSET/OFFSET study: antiplatelet activity of ticagrelor vs clopidogrel [Gurbel 2009:O,D,P] Ticagrelor Clopidogrel Gurbel PA, et al. Circulation. 2009;120:2577-2585.

  19. ATLANTIC study population and design STE-ACS planned for PCI N=1770 (n=1862*) Written informed consent in mobile care unit Symptoms of acute MI or more than 30 min but less than 6 h New persistent ST-segment elevation ≥1 mm in two or more contiguous ECG leads Randomized, double-blind Pre-hospital Ticagrelor 180 mg loading dose Placebo loading dose In-hospital Placebo loading dose Ticagrelor 180 mg loading dose Primary objective ≥70% ST-segment elevation resolution pre-PCI TIMI flow grade 3 of MI culprit vessel at initial angiography OR Ticagrelor 90 mg/bid 30 days *Consented and randomized Montalescot G et al. Am Heart J 2013;165:515–522 Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  20. ATLANTIC: Primary objective • To assess the efficacy of pre-hospital administration of ticagrelor compared to an in-hospital administration by comparing percentage of patients not achieving the co-primary endpoints: Montalescot G et al. Am Heart J 2013;165:515–522; Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  21. ATLANTIC: Co-primary and secondary surrogate endpoints Pre-hospital P=NS In-hospital • Pre-PCI • Pre-hospital n=774 • In-hospital n=824 • Post-PCI • Pre-hospital n=713 • In-hospital n=743 P=NS Pre-PCI Post-PCI P values were calculated from a logistic regression model, with treatment as the only explanatory variable Absence of ST-segment elevation ≥70% Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  22. ATLANTIC: Co-primary and secondary surrogate endpoints Pre-hospital P=NS In-hospital • Pre-PCI • Pre-hospital n=824 • In-hospital n=856 • Post-PCI • Pre-hospital n=760 • In-hospital n=784 P=NS Pre-PCI Post-PCI P values were calculated from a logistic regression model, with treatment as the only explanatory variable Absence of TIMI flow grade 3 in infarct-related artery Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  23. ATLANTIC : Clinical endpoints at 30 days Composites (mITT) Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  24. ATLANTIC: Clinical endpoints at 30 days †Fisher’s exact test‡Probable stent thrombosis was defined as any death occurring in a stented patient within 30 days §Exact confidence interval Difference in binomial proportions calculated for pre-hospital – in-hospital ticagrelor Stent thrombosis (mITT) Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  25. ATLANTIC: Clinical endpoints at 30 days Other CV and thrombotic bail-out (mITT)

  26. ATLANTIC RESULTS: Major adverse CV events up to 30 days 7 Ticagrelor pre-hospital Ticagrelor in-hospital 6 5 4 Event rate (KM %) 3 Ticagrelor pre-hospital 41/906 (4.5%) vs ticagrelor in-hospital 42/952 (4.4%) OR 1.03 (95% CI 0.66, 1.0); P=0.9056 2 1 0 0 4 8 12 16 20 24 28 30 Time (days) Major adverse CV events: death, myocardial infarction, stroke or urgent revascularization Kaplan–Meier curves Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  27. ATLANTIC: Non-CABG-related bleeding events P=NS Pre-hospital In-hospital P=NS P=NS P=NS P=NS P=NS Composite of major and minor Major Minor Major Minor Composite of major and minor Within 48 h of first dose After 48 h up to 30 d PLATO definitions (safety population) Pre-hospital n=908; in-hospital n=950 Events occurring up the date of the last visit (to a maximum of 32 days) are included in the table. Patients could be on study treatment or not when the event occurred. Patients may be counted in more than one bleeding event categoryP values were calculated from Chi-square test Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  28. ATLANTIC: Definite acute stent thrombosis up to 30 days Ticagrelor pre-hospital 2 Ticagrelor in-hospital 1 Event rate (KM %) Ticagrelor pre-hospital 2/906 (0.2%) vs ticagrelor in-hospital 11/952 (1.2%) OR 0.19 (95% CI 0.04, 0.86), P=0.02 0 Time (days) 24 h P=0.008 30 days P=0.02 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Kaplan–Meier curves Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  29. ATLANTIC: Median times to pre- and in-hospital steps Randomization Onset of symptoms ECG Pre-hospital ECG Pre-PCI LD1 LD2 Angiography PCI 31 min 14 min 73 min 90 min 63 min 28 min 159 min Montalescot G et al. N Engl J Med September 1, 2014 [Epub ahead of print; DOI: 10.1056/NEJMoa1407024]

  30. ROMANIA: Building the National STEMI network Competency in Interventional Cardiology On duty paied lines 2011 National Health House budget for medication Specific state budget PCI STEMI 1000 Euro/PCI 2010 National program for interventional STEMI treatment RO-STEMI registry Pre-hospital STEMI guidelines 2009 2008 10 Cathlabs Emergency rooms SMURD

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