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IV Heparin, (ASA), Beta-blockers, Nitrates, Ca ++ blockers

TIMI IIIA. Protocol Design. 391 Patients with Unstable Angina / NQWMI. IV Heparin, (ASA), Beta-blockers, Nitrates, Ca ++ blockers. Angio Exclusion: no CAD or LMain. Baseline Angio. Randomize. Placebo. t-PA 0.8 mg/kg over 90 mins. Primary Endpoint: Death, MI, Positive ETT 6 weeks.

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IV Heparin, (ASA), Beta-blockers, Nitrates, Ca ++ blockers

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  1. TIMI IIIA Protocol Design 391 Patients with Unstable Angina / NQWMI IV Heparin, (ASA), Beta-blockers, Nitrates, Ca++ blockers Angio Exclusion: no CAD or LMain Baseline Angio Randomize Placebo t-PA 0.8 mg/kg over 90 mins Primary Endpoint: Death, MI, Positive ETT 6 weeks Angio 18-36 hrs Follow-up 6 weeks Circulation 1993;87:38-52

  2. TIMI IIIA Primary Results Effects of tPA on Coronary Lesions BASELINE ANGIORAPHY: Apparent thrombus No thrombus 35% 35% Possible thrombus 30% ANGIORAPHY AFTER tPA: Improvement in Culprit Lesion: 25% t-PA vs. 19% placebo p=NS TIMI IIIA Investigators. Circulation 1993;87:38-52.

  3. TIMI IIIB Protocol Design 1473 Patients with Unstable Angina / NQWMI ASA, IV Heparin, Beta-blockers, Nitrates, Ca++ blockers Randomize Early Conservative: ST Holter, ETT Thallium Cath/PTCA if +ischemia Early Invasive: Cath 18-48 h PTCA/CABG prn 2x2 Factorial: t-PA vs. Placebo 1o Endpoint Inv-Cons: Death, MI, Positive ETT - 6 weeks ETT 6 weeks 1o Endpoint t-PA: Death, MI, Rec Isch, + ETT, Thallium or ST Holter Circulation 1994;89:1545-56 Follow-up 1 year

  4. TIMI IIIB Primary Results tPA vs. Placebo in Non-ST Elevation ACS Composite Endpoint Death or MI ICH % of Patients P = NS P = 0.05 P = 0.05 TIMI IIIB Investigators. Circulation 1994;89:1545-56

  5. TIMI IIIB Primary Results Early Invasive vs. Conservative Strategy Events at 42dInvasiveConservative pvalue No. Pts 740 733 Death (%) 2.4 2.5 NS MI (%) 5.1 5.7 NS D/MI/+ETT (%) 16.2 18.1 NS Rehosp Angina (%) 7.8 14.1 <0.001 D/MI/Rehosp (%) 15 22 0.007 LOS (days) 10.2 10.9 <0.001 # Days rehosp 365 930 <0.001 TIMI IIIB Investigators. Circulation 1994;89:1545-56

  6. TIMI IIIREGISTRY Protocol Design • All consecutive patients admitted with unstable angina were screened. • Inclusion Criteria: Ischemic pain >5 mins within 96 hrs with unstable pattern: At rest, accelerating, post MI • Exclusion Criteria: Non-ischemic pain, ST elevation, admitted for revascularization procedure • Patients in specific subgroups defined by gender, race and age were randomly selected for detailed evaluation and follow-up at 6 weeks and 1 year.

  7. TIMI IIIREGISTRY Risk Stratification Admission ECG as a prognostic indicator _ ST deviation >0.1 mV LBBB Tw change No ECG changes 25 22.9 Death or MI 20 15 11 % of Patients 8.2 10 6.8 6.6 3.7 3.7 3.6 5 2.6 1.6 1.6 0.8 0 In-Hospital 6 Weeks 1 Year Stone PH, TIMI III Registry Study Group. JAMA 1996;275:1104-1112. Cannon CP et al for ECG Substudy Investigators. JACC 1997;30:133-40.

  8. TIMI IIIB Risk Stratification cTnI to Predict Risk of Mortality in ACS Enrolled 0-6 hrs Enrolled 6-24 hrs Enrolled 0-24 hrs P<0.001 P <0.05 P<0.001 P <0.05 Antman et al. NEJM 1996; 335:1342-9

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