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STREAM Strategic Reperfusion Early After Myocardial Infarction

STREAM Strategic Reperfusion Early After Myocardial Infarction. Frans Van de Werf: Disclosures. Study grant from Boehringer Ingelheim to perform the STREAM trial, paid to the University of Leuven, Belgium

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STREAM Strategic Reperfusion Early After Myocardial Infarction

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  1. STREAMStrategic Reperfusion Early After Myocardial Infarction

  2. Frans Van de Werf: Disclosures • Study grant from Boehringer Ingelheim to perform the STREAM trial, paid to the University of Leuven, Belgium • Honoraria from Boehringer Ingelheim for membership of advisory board related to studies with dabigatran in patients with mechanical heart valves

  3. BACKGROUND • Large contemporary international registries continue to demonstrate persisting delays to primary PCI in STEMI patients first presenting to EMS or non-cath capable hospitals • Subsequent transfer for primary PCI commonly results in reperfusion times exceeding current guideline recommendations • These delays are associated with commensurate increases in morbidity and mortality

  4. STUDY AIM A strategy of early fibrinolysisfollowed 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.

  5. SAMPLE SIZE AND STATISTICAL ANALYSES 1000 patients per group was planned Primary endpoint in PPCI group projected to be 15.0% No formal primary hypothesis / all analyses explorative Data reported on ITT basis with 95% CI Analysis performed independently KU Leuven, Belgium

  6. 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 B: primary PCI Strategy A: pharmaco-invasive After 20% of the planned recruitment, the TNK dose was reduced by 50% among patients ≥75 years of age. <75y:full dose no lytic ≥75y: ½ dose TNK Ambulance/ER Aspirin Clopidogrel: LD 300 mg + 75 mg QD Enoxaparin: 30 mg IV + 1 mg/kg SC Q12h Aspirin Clopidogrel: 75 mg QD Enoxaparin: 0.75 mg/kg SC Q12h Antiplatelet and antithrombin treatment according to local standards ECG at 90 min: ST resolution ≥ 50% PCI Hospital NO YES Standard primary PCI angio >6 to 24 hrs PCI/CABG if indicated immediate angio + rescue PCI if indicated Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30

  7. ENROLMENT AND KEY DATES Enrolment setting 1892patients randomizedby 99 sites in 15 countries First patient in: March 19, 2008 Last patient in: July 26, 2012 Last patient out: Sep 7, 2012

  8. PATIENTS PER COUNTRY

  9. BASELINE CHARACTERISTICS (1) Data are mean (SD) or %

  10. BASELINE CHARACTERISTICS (2) Data are %

  11. MEDIAN TIMES TO TREATMENT (min) 1st Medical contact Randomize IVRS Sxonset Rx TNK 100 min 62 29 9 78 min difference 1st Medical contact Sxonset Randomize IVRS Rx PPCI 61 31 86 1 Hour 2 Hours 178 min n=1892

  12. MEDIAN TIMES TO TREATMENT (min) 1st Medical contact Randomize IVRS Sxonset Rx TNK 36% Rescue PCI at 2.2h 100 min 62 29 9 64% non-urgent cath at 17h 1st Medical contact Sxonset Randomize IVRS Rx PPCI 61 31 86 178 min 1 Hour 2 Hours n=1892

  13. TIMI FLOW RATES P=0.41 P<0.001 TIMI after PCI TIMI before PCI

  14. INVASIVE PROCEDURES

  15. PRIMARY ENDPOINT TNK vs PPCI Relative Risk 0.86, 95%CI (0.68-1.09) PPCI 14.3% TNK 12.4% p=0.24 Dth/Shock/CHF/ReMI (%) The 95% CI of the observed incidence in the pharmaco-invasive arm would exclude a 9% relative excess compared with PPCI

  16. SINGLE ENDPOINTS UP TO 30 DAYS

  17. Subgroup analyses for primary endpoint within 30 days P(interaction) Relative Risk (95%CI) OVERALL Age <75 years 0.63 ≥75 years Time to randomization 0 to <2h 0.81 ≥2h Male 0.71 Female Systolic blood pressure <100 mmHg 0.16 100 to <140 mmHg 140 to <160 mmHg ≥160 mmHg Killip class I 0.23 II-IV Anterior MI 0.06 Inferior MI > Other MI TNK Better PPCI Better

  18. Subgroup analyses for primary endpoint within 30 days P(interaction) Relative Risk (95%CI) 0.34 Hypertension, Yes No Diabetes, Yes 0.24 > No > Weight, <60 kg 0.35 60 to <90 kg ≥90 kg Place of randomization, Ambulance 0.68 Community hospital TIMI Risk Score, <5 points 0.71 ≥5 points Before Amendment After Amendment p=0.07 0.13 TNK Better PPCI Better

  19. STROKE RATES

  20. IN-HOSPITAL BLEEDING COMPLICATIONS

  21. 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.

  22. ACKNOWLEDGEMENTS

  23. CLINICAL OUTCOMES Before amendment (N=379) After amendment (N=1503)

  24. CLINICAL OUTCOMES Before amendment (N=379) After amendment (N=1503)

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