Current Advances and Best Practices in Acute STEMI Management A pharmacoinvasive approach
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1 Current Advances and Best Practices in Acute STEMI Management A pharmacoinvasive approach Frans Van de Werf, MD, PhD University Hospitals, Leuven, Belgium
2 Frans Van de Werf: Disclosures Research grants for conducting trials on reperfusion therapy: Boehringer Ingelheim, Genentech, SanofiAventis, Proctor&Gamble, Wyeth Speaker s bureau: Boehringer Ingelheim, Genentech, SanofiAventis, Merck, AZ Advisory board: Boehringer Ingelheim, Menarini, GSK, Merck, AZ, The Medicines Company 12/10/2013
3 The Benefit of Reperfusion therapy for STEMI is very much time dependent! 12/10/2013
4 Progression of Cell Death versus Time after Coronary Occlusion in Dogs AP AP AP 40 minutes 3 hours 96 hours = Nonischemic = Ischemic (Viable) = Necrotic Reimer and Jennings, Lab Invest 1979; 40: /10/2013
5 Salvageable Ischemic Myocardium with Respect to the Duration of Ischemia % min 3 hours 6 hours Duration of occlusion Reimer and Jennings, Lab Invest 1979; 40: /10/2013
6 The Importance of Time to Reperfusion Tiefenbrunn AJ, Sobel BE. Circulation 1992; 85: /10/2013
7 Absolute Benefitt per 1,000 Treated Patients The Importance of Time to Reperfusion A Meta-analysis of 50,246 Pts in placebo controlled trials of Lytic Therapy Boersma E, et al. Lancet. 1996; 348: Time to Treatment 12/10/2013
8 Primary PCI : Time to treatment and 1-year mortality as continuous function. Every 30 minutes increase of relative risk of 1-year mortality of 7.5 % De Luca G et al. Circulation 2004;109:
9 Landmark Clinical Studies The efficacy of intravenous streptokinase. GISSI-1, Lancet 1986 The additional survival benefit with upfront aspirin in combination with streptokinase. ISIS-2, Lancet 1988 The greater survival benefit with a fibrin-specific agent (tpa) as compared with streptokinase. GUSTO-I, New Engl J Med 1993 The superiority of primary PCI over in-hospital fibrinolytic therapy,meta-analysis, Lancet 2003
10 Mortality % Early Mortality Rates (21-35 days) in Major Randomized STEMI trials: GISSI-1 Control n=5, GISSI-1 SK n=5, ISIS-2 SK + Aspirin n=4, GUSTO-1 tpa n=10, ASSENT-4 Prim PCI n=838 APEX-MI Prim PCI n=2, HORIZONS -AMI n=3,340 12/10/2013
11 The Benefit of Reperfusion ORs by Year for In-Hospital All-Cause Mortality, Stratified by Age (2003 = base) Gale C P et al. Eur Heart J 2011;eurheartj.ehr381
12 Time delays remain a major problem! 12/10/2013
13 Frequency, % On-Site Thrombolysis vs Transfer for PCI PTCA (n = 1466) Thrombolytic therapy (n = 1443) P < P = P < P = P = Death Non-fatal Myocardial Infarction Total Stroke Haemorrhagic Stroke Death, Non-fatal Reinfarction or Stroke Keeley et al. Lancet
14 Mortality in 6209 Danish Patients With STEMI Treated With Primary PCI Terkelsen, C. J. et al. JAMA 2010;304:
15 HORIZONS-AMI: Median Door-to-Balloon Times Blankenship et al Am J Card 2010;106: /10/2013
16 Multivariate predictors of longer door-to-balloon time in pts from HORIZONS -AMI Variable Estimate SE p Value Presentation to non-angioplasty hospital <0.001 Respiratory failure Previous congestive heart failure Presentation during daytime weekday hours <0.001 Diabetes mellitus <0.001 Previous angina Men Infarct-related artery: circumflex Left ventricular ejection fraction Blankenship et al. Am J Card 2010;106:1527
17 Hospitals with cath labs UNITED STATES 18.0% EUROPE 10.0% BRAZIL 5.5% CENIC REGISTRY, 2011, Brazil.
18 Only 55% of all PCI centres offer 24/7 PPCI service Widimsky P et al. Eur Heart J 2010;31:
19 Door-In to Door-Out Time Among Patients Transferred for Primary PCI in the USA Distribution of median door-in to door-out (DIDO) times for 1034 hospitals reporting at least 5 patients in 2009 Arch Intern Med. 2011;171(21):
20 Problems and challenges in cardiovascular emergencies
21 STUDY AIM A strategy of early fibrinolysis followed by coronary angiography within 6-24 hours or rescue PCI if needed was compared with standard primary PCI in STEMI patients with at least 2 mm ST-elevation in 2 contiguous leads presenting within 3 hours of symptom onset and unable to undergo primary PCI within 1 hour. F. Van de Werf, ACC 2013
22 PCI Hospital Ambulance/ER STUDY PROTOCOL STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2 leads RANDOMIZATION 1:1 by IVRS, OPEN LABEL Strategy A: pharmaco-invasive Strategy B: primary PCI <75y:full dose Aspirin Clopidogrel: LD 300 mg + 75 mg QD Enoxaparin: 30 mg IV + 1 mg/kg SC Q12h After 75y: 20% ½ of dose the TNK planned recruitment, the TNK dose was reduced by 50% among patients 75 years of age. Aspirin Clopidogrel: 75 mg QD Enoxaparin: 0.75 mg/kg SC Q12h no lytic Antiplatelet and antithrombin treatment according to local standards ECG at 90 min: ST resolution 50% YES NO angio >6 to 24 hrs PCI/CABG if indicated immediate angio + rescue PCI if indicated Standard primary PCI Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30 F. Van de Werf, ACC 2013
23 PATIENTS PER COUNTRY F. Van de Werf, ACC 2013
24 MEDIAN TIMES TO TREATMENT (min) Sx onset 1st Medical contact Randomize IVRS Rx TNK min Sx onset 1st Medical contact Randomize IVRS 78 min difference Rx PPCI n= Hour 2 Hours 178 min F. Van de Werf, ACC 2013
25 MEDIAN TIMES TO TREATMENT (min) Sx onset 1st Medical contact Randomize IVRS Rx TNK 36% Rescue PCI at 2.2h min 64% non-urgent cath at 17h Sx onset 1st Medical contact Randomize IVRS Rx PPCI n= Hour 2 Hours 178 min F. Van de Werf, ACC 2013
26 TIMI FLOW RATES P<0.001 P=0.41 TIMI before PCI TIMI after PCI F. Van de Werf, ACC 2013
27 INVASIVE PROCEDURES Pharmaco-invasive (N=944) PPCI (N=948) P-value PCI performed 80% 90% <0.001 Stents deployed 96% 96% 0.95 CABG performed 4.7% 2.1% F. Van de Werf, ACC 2013
28 Dth/Shock/CHF/ReMI (%) PRIMARY ENDPOINT TNK vs PPCI Relative Risk 0.86, 95%CI ( ) The 95% CI of the observed incidence in the pharmaco-invasive arm would exclude a 9% relative excess compared with PPCI PPCI 14.3% TNK 12.4% p=0.24 F. Van de Werf, ACC 2013
29 SINGLE ENDPOINTS UP TO 30 DAYS Pharmaco-invasive PPCI P-value (N=944) (N=948) All cause death (43/939) 4.6% (42/946) 4.4% 0.88 Cardiac death (31/939) 3.3% (32/946) 3.4% 0.92 Congestive heart failure (57/939) 6.1% (72/943) 7.6% 0.18 Cardiogenic shock (41/939) 4.4% (56/944) 5.9% 0.13 Reinfarction (23/938) 2.5% (21/944) 2.2% 0.74 F. Van de Werf, ACC 2013
30 Subgroup analyses for primary endpoint within 30 days OVERALL Age <75 years 75 years Time to randomization 0 to <2h 2h Male Female Systolic blood pressure <100 mmhg 100 to <140 mmhg 140 to <160 mmhg 160 mmhg Killip class I II-IV Anterior MI Inferior MI Other MI Relative Risk (95%CI) P(interaction) > TNK Better PPCI Better F. Van de Werf, ACC 2013
31 Subgroup analyses for primary endpoint within 30 days Hypertension, Yes No Diabetes, Yes No Weight, <60 kg 60 to <90 kg 90 kg Place of randomization, Ambulance Community hospital TIMI Risk Score, <5 points 5 points Before Amendment After Amendment Relative Risk (95%CI) p=0.07 P(interaction) > > TNK Better PPCI Better F. Van de Werf, ACC 2013
32 STROKE RATES Pharmaco-invasive PPCI P-value TOTAL POPULATION (N=1892) Total stroke 15/939 (1.60%) 5/946 (0.53%) 0.03 fatal stroke 7/939 (0.75%) 4/946 (0.42%) 0.39 Haemorrhagic stroke 9/939 (0.96%) 2/946 (0.21%) 0.04 fatal haemorrhagic stroke 6/939 (0.64%) 2/946 (0.21%) 0.18 POST AMENDMENT POPULATION (N=1503) Total stroke 9/747 (1.20%) 5/756 (0.66%) 0.30 fatal stroke 3/747 (0.40%) 4/756 (0.53%) >0.999 Haemorrhagic stroke 4/747 (0.54%) 2/756 (0.26%) 0.45 fatal haemorrhagic stroke 2/747 (0.27%) 2/756 (0.26%) >0.999 F. Van de Werf, ACC 2013
33 IN-HOSPITAL BLEEDING COMPLICATIONS Pharmaco-invasive (N=944) PPCI (N=948) P-value Major non-ich bleeding 6.5% 4.8% 0.11 Minor non-ich bleeding 21.8% 20.2% 0.40 Blood transfusions 2.9% 2.3% 0.47 F. Van de Werf, ACC 2013
34 CONCLUSIONS A strategy of fibrinolysis with bolus tenecteplase and contemporary antithrombotic therapy given before transport to a PCI-capable hospital coupled with timely coronary angiography : circumvents the need for an urgent procedure in about two thirds of fibrinolytic treated STEMI patients. is associated with a small increased risk of intracranial bleeding. is as effective as primary PCI in STEMI patients presenting within 3 hours of symptom onset who cannot undergo primary PCI within one hour of first medical contact. F. Van de Werf, ACC 2013
35 F. Van de Werf, ACC 2013
36 Reperfusion: Conclusions Anno 2013 Reperfusion therapy is the most effective treatment to offer to STEMI patients and is its broad application has significantly reduced case fatality rates both in studies and in the real world over the last 20 years Major efforts are still needed to shorten delay times especially in patients presenting first to facilities without a cath lab Distances,weather and traffic conditions are a frequent reason why patients can t get timely PCI Especially in patients presenting early to an ambulance system or hospital without a cath lab fibrinolytic therapy should be considered when there is any doubt about timely PCI 12/10/2013
37 12/10/2013
38 Frequency, % STE ACS Primary PCI vs In-HospitalThrombolysis : Clinical Outcomes Short-Term Outcomes P < P < P = P = P < P = P < P = Death Death, Excluding SHOCK Data Non-fatal Myocardial Infarction Recurrent Ischemia Total Stroke Haemorrhagic Stroke Major Bleed Death, Non-fatal Reinfarction, or Stroke Long-Term Outcomes P < PTCA 30 P = P = P < Thrombolytic therapy P < Death Death, Excluding SHOCK Data Non-fatal Myocardial Infarction Recurrent Ischemia Total Stroke Haemorrhagic Stroke Major Bleed Death, Non-fatal Reinfarction, or Stroke Keeley and Grines Lancet /10/2013
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