Διευκολυνόμενη αγγειοπλαστική στο STEMI. Κωνσταντίνος Τριανταφύλλου, MD, PhD Επιμελητής A Καρδιολογικό Τμήμα Π.Γ.Ν. «Ευαγγελισμός»

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1 Διευκολυνόμενη αγγειοπλαστική στο STEMI Κωνσταντίνος Τριανταφύλλου, MD, PhD Επιμελητής A Καρδιολογικό Τμήμα Π.Γ.Ν. «Ευαγγελισμός»

2 Πιθανή σύγκρουση συμφερόντων Ομιλητής: Κωνσταντίνος Τριανταφύλλου Δεν έχω πιθανή σύγκρουση συμφερόντων σχετική με την παρουσίαση αυτή.

3 STEMI: Σημασία χρόνου ισχαιμίας Gersh BJ, et al. JAMA 2005;293:979. Stone GW, Gersh BJ. Lancet 2006;367:543-6.

4 STEMI: Σημασία χρόνου επαναιμάτωσης Cannon CP, et al. JAMA 2000;283:2941. Rathore SS, et al. BMJ 2009;338:1807.

5 Primary PCI vs. Thrombolysis. Does time matter? A pooled analysis of RCTs comparing primary PCI and in-hospital fibrinolysis in acute MI patients. Boersma E. Eur Heart J 2006;27:

6 30-day mortality 30-day mortality Early Presenting Patients: Primary PCI v Fibrinolytics 20% Lytic (SK) Transfer for PCI 10% Pre-hosp tpa PCI 15% 15.3% p<0.02 8% 6% p= % p= % 10% 5% 7.4% 7.3% 6.0% 4% 2% 2.2% 3.7% 0% 0% <3 Hrs (n=551) >3 Hrs (n=299) <2 Hrs (n=460) >2 Hrs (n=374) 6 PRAGUE-2 Widimsky P, et al. Eur Heart J. 2003;24(1): CAPTIM Steg PG, et al. Circulation. 2003;108(23):

7 Benefit of transferring STEMI patients for PCI compared with administration of onsite fibrinolytic declines as delays increase. Pinto DS, et al. Circulation 2011;124:

8 PCI after fibrinolysis: a multiple meta-analyses approach according to the type of strategy. 30-day death or MI Rescue PCI Collet JP, et al. J Am Coll Cardiol 2006;48:

9 Facilitated PCI ASSENT- 4 PCI Large Acute MI (> 6 mm ST Elevation), <6 hr Sx Onset No Upper Age Limit Delay in Arriving in Cath Lab > 75 minutes TNK Heparin ASA n=2,000 Open-Label Randomization No lytic UFH ASA n=2,000 Superiority power assumptions: 15% events rate in control, 12% in experimental group Angiography/ PCI GP IIb/IIIa not permitted, in patients >75 y Enox dosing is 15 mg IV bolus, then 0.75 mg/kg, Clopidogrel for stented patients Angiography/ PCI GP IIb/IIIa may be used at MD discretion, additional UFH per ACT, Clopidogrel for stented patients Composite endpoint: Death, New Cardiogenic Shock, or Refractory Cardiac Failure at 90 Days ASSENT = Assessment of the Safety and Efficacy of a New Thrombolytic Regimen. 9

10 Facilitated PCI Primary versus tenecteplase-facilitated PCI in patients with STEMI (ASSENT-4 PCI): randomized trial 19% 13% Death, CHF, CS w/in 90 days Lancet 2006;367:

11 Facilitated PCI Facilitated PCI in patients with ST-elevation myocardial infarction. (FINESSE study) Death, VF > 48 hrs, CS & CHF w/in 90 days. N Engl J Med 2008;358:

12 Facilitated angioplasty with combo therapy* among patients with STEMI: a meta-analysis of randomized trials. *Facilitated PCI with adjunctive Gp IIb-IIIa inhibitors and reduced lytic therapy vs adjunctive Gp IIb-IIIa inhibitors among patients with STEMI. Death Reinfarction Major bleeding De Luca G, Marino P. Am J Emerg Med 2009;27:

13 Facilitated PCI Comparison of primary and facilitated PCI for STEMI: quantitative review of randomized trials (17 trials) Facilitated PCI (n=2237) was associated with significantly worse short term outcomes (up to 42 days) than primary PCI (n=2267) alone: Death : 5% vs 3% Non-fatal MI : 3% vs 2% Urgent TVR: 4% vs 1% Major bleeding : 7% vs 1% Total stroke: 1.1% vs 0.3% Increased rates of adverse events observed mainly when thrombolytic therapy was used to facilitate PCI Keeley EC, Boura JA, Grines CL. Lancet 2006;367:

14 Stone GW, Gersh BJ. Lancet 2006;367: The great tragedy of Science the slaying of a beautiful hypothesis by an ugly fact Thomas Henry Huxley ( ) Expulsion from Paradise, Michelangelo Buonarroti ( ), Sistine Chapel, Vatican, Rome.

15 Facilitated PCI Rationale: More probable TIMI II/III flow restoration in IRA before PCI* Pharmacoinvasive strategy Routine early PCI Rescue PCI Ibanez B, et al ESC STEMI Guidelines. Eur Heart J 2018; 39: *Reduced ischemia time, facilitated guidewire passage, decresed clot burden, lower incidence of distal embolization, improved prognosis.

16 Immediate PCI versus standard therapy with rescue angioplasty after thrombolysis. CARESS-in-AMI Immediate transfer for PCI improves outcome in high-risk patients with STEMI treated at a non-interventional center with half-dose reteplase and abciximab. Di Mario C, et al. Lancet 2008;371:

17 % Pharmacoinvasive vs Lysis for high risk STEMI Primary Endpoint* at 30 Days N=1,004 pts OR=0.64 (0.47, 0.87) p= Days from Randomization Standard (n=496) Pharmacoinvasive (n=508) *Primary EP: Death, re-mi, CHF, Severe re-ischemia, Shock Cantor WJ, et al. N Engl J Med 2009;360:

18 Early routine PCI after fibrinolysis vs. standard therapy in STEMI: a meta-analysis Stroke & major bleeding: No difference Borgia F, et al. Eur Heart J 2010;31:

19 Routine early coronary angioplasty versus ischaemia-guided angioplasty after thrombolysis in acute STEMI: a meta-analysis. 30-day death, re-mi, ischemia 30-day re-mi 30-day ischemia 30-day death D'Souza SP, et al. Eur Heart J 2011;32:

20 Timing of invasive treatment after fibrinolysis in STEMI: a meta-analysis of immediate or early routine versus deferred or ischemia-guided randomized controlled trials. Mortality Recurrent MI Stroke & major bleeding: No difference Desch S, et al. Heart 2010;96: Recurrent ischemia

21 Reperfusion Options for Transfer Patients

22 PCI after Fibrinolysis for STEMI Patients: An Updated Systematic Review and Meta-Analysis Short-term mortality for immediate or early PCI after fibrinolysis versus primary PCI alone. PCI <2 hrs after fibrinolysis : More deaths, remi & major bleeding PCI 2-24 hrs after fibrinolysis Liu F, et al. PLoS One 2015;10:e

23 Fibrinolysis or primary PCI in STEMI. STREAM trial 1892 patients with STEMI, <3 hours after symptom onset, no primary PCI within 1 hour. Primary PCI vs fibrinolytic therapy with bolus TNK (amended to half dose in patients 75 years of age), clopidogrel, and enoxaparin before transport to a PCI-capable hospital 14.3% 12.4% Primary end point : composite of death from any cause, shock, congestive heart failure, or reinfarction within 30 days (p=0.21 by the log- rank test). Armstrong PW, et al. N Engl J Med 2013;368:

24 Ibanez B, et al ESC STEMI Guidelines. Eur Heart J 2018; 39: & Neumann FJ, et al ESC Guidelines on myocardial revascularization. Eur Heart J 2018; doi: /eurheartj/ehy394

25 Ibanez B, et al ESC STEMI Guidelines. Eur Heart J 2018; 39: & Neumann FJ, et al ESC Guidelines on myocardial revascularization. Eur Heart J 2018; doi: /eurheartj/ehy394

26 ppci Στην ένοχο αρτηρία Stenting DES τελευταίας γενιάς Κερκιδική προσπέλαση Ι - Α Ibanez B, et al ESC STEMI Guidelines. Eur Heart J 2018; 39: & Neumann FJ, et al ESC Guidelines on myocardial revascularization. Eur Heart J 2018; doi: /eurheartj/ehy394

27 Fibrin specific agent (TNK) + ASA + Clopidogrel + enoxaparin (> vs UFH) Ibanez B, et al ESC STEMI Guidelines. Eur Heart J 2018; 39: & Neumann FJ, et al ESC Guidelines on myocardial revascularization. Eur Heart J 2018; doi: /eurheartj/ehy394

28 C Clopidogrel is the P2Y12 inhibitor of choice as co-adjuvant and after fibrinolysis, but 48 h after fibrinolysis, switch to prasugrel/ticagrelor may be considered in patients who underwent PCI. Ibanez B, et al ESC STEMI Guidelines. Eur Heart J 2018; 39: & Neumann FJ, et al ESC Guidelines on myocardial revascularization. Eur Heart J 2018; doi: /eurheartj/ehy394

29 Ticagrelor vs Clopidogrel After Fibrinolytic Therapy in Patients With STEMI: A Randomized Clinical Trial. 30 days Berwanger O, et al. JAMA Cardiol 2018;3:391-9.

30 Συμπεράσματα (I) Η διευκολυνόμενη (facilitated) PCI στο STEMI δοκιμάστηκε σε μελέτες της προηγούμενης 10ετίας χωρίς επιτυχία. Επί STEMI που αντιμετωπίζεται αρχικά σε νοσοκομείο χωρίς δυνατότητα ppci το δίλημμα έχει ως εξής: 1. Άμεση μεταφορά για πρωτογενή PCI χωρίς θρομβόλυση: Ασθενείς με shock ή άλλα χαρακτηριστικά υψηλού κινδύνου, υψηλός αιμορραγικός κίνδυνος, >3 ώρες από έναρξη συμπτωμάτων & βραχύς χρόνος μεταφοράς για ppci. 2. Αρχική θεραπεία με θρομβόλυση: Ασθενείς με χαμηλό αιμορραγικό κίνδυνο, < 2-3 ώρες από έναρξη συμπτωμάτων & μακρός χρόνος μεταφοράς για ppci.

31 Συμπεράσματα (IΙ) 2 = Φαρμακο-επεμβατική ( pharmaco-invasive) στρατηγική*: Η κατά ρουτίνα άμεση μεταφορά για early routine PCI εντός 2-24 ωρών μετά τη θρομβόλυση προτιμάται (ιδίως σε ασθενείς υψηλού κινδύνου) γιατί : 1. Περιλαμβάνει την PCI διασώσεως (rescue). 2. Προλαμβάνει την πρώιμη επανέμφραξη της ενόχου αρτηρίας. *Πολύ σημαντική η χρήση φαρμάκων σύμφωνα με κατευθυντήριες οδηγίες. Ευχαριστώ πολύ για την προσοχή σας.