Primary angioplasty


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1 : EXPERTS WORKSHOP ON EARLY TREATMENT STRATEGIES FOR ACUTE MYOCARDIAL INFARCTION FOR THE MIDDLE EAST COUNTRIES FEBRUARY 26TH -28TH 2005 / DUBAI, UAE SPONSORED BY BOEHRINGER INGELHEIM SUNDAY, 27th FEBRUARY – SESSION 2 A rationale for pre-hospital thrombolytic therapy Patrick Goldstein
2 : Fire! Your house is on fire...
3 : The Fire Spreads Quickly Every second is crucial, the damage is getting worse
4 : Transportation!? You are watching the firemen loading the burning stuff...
5 : To Extinguish the Fire! ”Time is muscle and life!”
6 : Cross-sections of left ventricle after experimental coronary artery occlusion (Reimer KA, et al. Circulation. 1977;56:786-794). “Time is Muscle”  Duration of occlusion 3 h Area supplied by occluded artery x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x
7 : Acute MI again? Why? ? It is serious ? It’s desperately urgent ? We must act efficiently, in order to significantly reduce mortality before arrival at the hospital ? The diagnosis is clinical ? The strategy and the therapeutic management are in constant movement
8 : “Time is muscle” MITI 4.9 11.2 14 12 10 8 6 4 2 0 Infarct Size (%) < 70 min 70-180 min
9 : Estimated benefit (lives saved at 35 days) per 1000 patients Time from onset (hours) Mortality Reduction Depends on the Delay “Onset of Pain - Thrombolytic Treatment” Eric Boersma’s meta-analysis (22 trials from 83 to 93 - 50 246 patients) BOERSMA, E. et al Early thrombolytic in acute myocardial treatment infarction : reappraisal of the golden hour - Lancet 1996 ; 771 - 775 0 12 18 24 6 0 20 40 60 80 11%
10 : Morrison’s Meta-analysis OBJECTIVE To realize a meta-analysis of randomized trials exploring mortality in pre-hospital vs in-hospital thrombolysed AMI INCLUDED STUDIES 6 studies (n = 6 434) RESULTS Delay pain to treatment : Pre-hospital thrombolysis = 104 min In-hospital thrombolysis = 162 min (diff = 58 min) (p=0.007) Significant reduction of the in-hospital death rate (all causes) with pre-hospital thrombolysis : (- 17%) (OR 0.83; 95% CI, 0.70-0.98). JAMA, May 2000 - Vol 283 - N° 20 - 2686-92
11 : Delay pain – treatment French experience
12 : Material and Drugs of the SMUR Diagnostics: ECG Mini laboratory Therapeutics: fibrinolytic heparin anti GP IIb/IIIa aspirin nitroglycerine morphine defibrillator electric syringe oxygen and more Monitoring : Scope Sao2
13 : ASSENT-3 Plus (Pre-hospital Treatment) Early treatment (ambulance-car) of AMI patients <6 hrs ASA RANDOMIZATION 1:1 TNK-tPA full dose 0.53 mg/kg bolus Unfractionated heparin 60 IU/kg bolus (max. 4000 IU) 12 IU/kg/hr infusion (max 1000 IU/ hr) target aPTT 50-70 sec Patients’ outcome will be compared with matched pairs extracted from the corresponding arm of the ASSENT-3 main study. The same exploratory endpoints (single and composite) as in the ASSENT-3 main study will be evaluated; the influence of time to treatment will be analyzed. (500) TNK-tPA full dose 0.53 mg/kg bolus Enoxaparin 30 mg i.v. bolus 1 mg/kg s.c. twice a day (500)
14 : Hours to treatment (median) 3+ 0 12 24 36 48 60 72 84 96 108 120 132 144 156 168 ENOX UFH TNK TNK
15 : Thrombolysis or PTCA still a debate ?
16 : CAPTIM Comparison of Angioplasty and Pre-hospital Thrombolysis In acute Myocardial infarction ESC 2001
17 : M I C U - SMUR CAPTIM Design ST segment ? onset of pain < 6 h All received ASA + Heparin Central randomisation In-hospital Pre-hospital PCI thrombolysis Diagnosis positive in 95%
18 : Primary Composite (30 day) ? all-cause mortality ? recurrent MI ? disabling stroke Secondary Cardiovascular death New onset of angina Urgent angioplasty Cardiogenic shock Hemorrhagic stoke Severe hemorrhage CAPTIM - Clinical Endpoints
:
20 : Cardiovascular death (%) New onset of angina (%) Urgent angioplasty (%) Cardiogenic shock (%) Hemorrhagic stoke (%) Severe hemorrhage (%) CAPTIM - secondary endpoints Pre-hospital thrombolysis n = 419 Primary PCI n = 421 P Value 3.8 7.2 33.0 2.5 0.5 0.5 4.3 4.0 4.0 4.9 0.0 2.0 0.86 0.09 < 0.01 0.09 0.49 0.06
21 : DANAMI-2 DENMARK 5.4 mill. inhabitants 5 PCI centers 24 referral hospitals 62% of Danish population Transport distance up to 95 US miles (mean 35 miles)
22 : DANAMI II ACC 2002 5 PCI centers + 22 referring hospitals distance average = 56 km 1129 patients 443 patients referring hospitals PCI centers no transfer ambulance PCI fibrinolysis transfer on site fibrinolysis Very high risk patients: ST > 4 mm
23 : Comparaison CAPTIM / DANAMI II Thrombolysis PCI p CAPTIM 8.2 % 6.2 % 0.29 DANAMI II combined 13.7 % 8.0 % 0.003 DANAMI II referring 14.2 % 8.5 % DANAMI II invasive 12.3 % 6.7 % 0.048 Combined Death, ReMI and stroke
24 : CAPTIM DANAMI II combined PHT PCI thrombolysis PCI Death 3.8 % 4.8 % 7.6 % 6.6 % Disabling 1.0 % 0.0 % 2.0 % 1.1 % stroke Reinfarction 3.7 % 1.7 % 6.3 % 1.6 % Look at the single endpoints: 30 days
25 : Preventing Reinfarction : IIb/IIIa Inhibitors, Enoxaparin, or Primary PCI PRAGUE-2 30-day deaths 6.8 v 10.0 % , p = 0.12 * 6-month data in press, Simes AHU 2002 ** Pre-hospital administration p < 0.05 reMI, death (PCAT only) ; stroke (PCAT only)
26 : DANAMI-2 vs CAPTIM vs ASSENT-3 Mortality at 30 days % (TNK + ENOX) ESSAI TOTAL 6.6 4.8 7.6 3.8 5.4 5.8 0 2 4 6 8 DANAMI-2 CAPTIM ASSENT-3 ASSENT3+ PCI TT
27 : Pre-Hospital Lysis Primary PCI Death CAPTIM 1-Year Results GW Symposium, AHA 2002 Death Pre-Hospital Lysis Primary PCI Sx < 2 hours Sx > 2 hours
28 : Pre-Hospital Lysis Primary PCI P=0.032 Shock Randomization to DC CAPTIM 1 Year Results GW Symposium, AHA 2002 P=0.0007 Shock Randomization to Adm Pre-Hospital Lysis Primary PCI Sx < 2 hours Sx < 2 hours
29 : All presented periods are median Beginning of pain 65 min Emergency call at SAMU 19 min PEC SMUR Beginning of thrombolysis 35 min 66 min Arrival at hospital 84 min Puncture According to ATLS: 32 min 120 min 185 min E-MUST Comparable periods
30 :
31 : The Lille Experience
32 : USIC 2000 French nationwide survey designed as a multicenter, prospective longitudinal study over one month Aim: to assess current practices and clinical outcome in patients admitted to an ICU for AMI in France Organisation : in-hospital outcome one-year follow-up
33 : One-month Mortality in Patients with Reperfusion Therapy: USIC 2000 n = 428 370 108 47 % 41 % 12 %
34 : USIC 2000: One-month Mortality in Patients with Reperfusion Therapy n = 370 108 428 41% 12% 47% 7.1 9.6 3.0 5.8 3.6 7.9 0 2 4 6 8 10 12 Hosp. lysis no PCI Pre-hosp. lysis no PCI Hosp. lysis + PCI Pre-hosp. lysis + PCI Primary PCI
35 : Combined Strategy of reperfusion
36 : The Combined Strategies of Reperfusion J.M. Julliard : A matched comparison of the combination of prehospital thrombolysis and stand bye rescue angioplasty with primary angioplasty. Am.J. Cardiol. 1999 ; 83 - 305-310. 170 patients in Paris city Pre-hospital Thrombolysis Angiography at 80 min TIMI 3 108 (64%) TIMI 2 12 (7%) TIMI 0 50 (29%) angioplasty TIMI 3 91% TIMI 2 7%
37 : Which Delays for This Technique of Combined Reperfusion PHT Admission = 58 ? 20 min Admission Angiography = 59 ? 19 min Then 2 h after PHT only 2% of patients are TIMI O or 1
38 : Outcome after Combined Reperfusion Therapy for AMI, Combining Pre-hospital Thrombolysis with Immediate PTCA and Stent 1995-1999 1010 patients with AMI (Paris Sud Cardiovascular Institute) 148 patients with pre-hospital full-dose thrombolytic therapy 131 patients included (median time = 2 h after onset of pain) C. Loubeyre and all. Eur. Heart J. 2001 ; 22 : 1128-1135
39 : 131 patients Angiography 95 min after TT 64 (49%) TIMI 3 54 (84%) PTCA 65 (50%) TIMI 0 - 2 PTCA 119 (91%) PTCA 114 stent 120/131 TIMI 3 (92%) 9/131 TIMI 2 2 TIMI 0-1 no emergency surgery From C. Loubeyre
40 : Long-term follow-up 2 ? 1 year mortality rate : 6% (8 patients) non-fatal re MI : 2 patients survival + no RI rate = 90% 94 patients (70%) symptom free - no re-hospitalization - no revascularization C. Loubeyre. Eur. Heart J. 2001 ; 22 : 1128-1135
41 : Early PCI versus Guided PCI after Lytics in the Modern Era Death Relative risk, fixed model Bilateral CI, 95% for trials, 95% for MA SIAM III 0.44 [0.14;1.37] GRACIA-1 0.57 [0.26;1.26] CAPITAL-AMI 0.67 [0.11;3.89] Total 0.54 [0.29;0.99] 0.047 Cochran Q het. p=0.91 Rel. Risk 0 1 2 3 4 0.538, p=0.047 RR CI p
42 : RESCUE 0.53 [0.16;1.75] REACT 0.51 [0.24;1.10] MERLIN 1.14 [0.59;2.20] LIMI 0.84 [0.27;2.65] Belenkie et al 0.19 [0.02;1.47] Total 0.73 [0.48;1.11] 0.138 Cochran Q het. P=0.33 Rescue PCI after Lytics Death 6 weeks Relative risk, fixed model Bilateral CI, 95% for trials, 95% for MA Rel. Risk 0.4 1.0 1.6 2.2 RR CI p
43 : Conclusion Pre-hospital thrombolysis is still the gold standard Very high risk patients MUST have a PCI with a minimum delay Transfer is not an additional risk ? Pre-hospital thrombolysis + Angioplasty
44 : Pre-hospital thrombolysis + immediate angioplasty + stent implantation is safe and effective EP. Mc Fadden. Eur. Heart J. 2001 ; 22 : 1067-69

 

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