TIMIIIIA研究.pptVIP

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. * IV Heparin, (ASA), Beta-blockers, Nitrates, Ca++ blockers Randomize Angio 18-36 hrs t-PA 0.8 mg/kg over 90 mins 391 Patients with Unstable Angina / NQWMI Placebo Primary Endpoint: Death, MI, Positive ETT 6 weeks Follow-up 6 weeks Circulation 1993;87:38-52 Baseline Angio Angio Exclusion: no CAD or LMain TIMI IIIA Protocol Design Apparent thrombus 35% Possible thrombus 30% No thrombus 35% Improvement in Culprit Lesion: 25% t-PA vs. 19% placebo p=NS TIMI IIIA Investigators. Circulation 1993;87:38-52. TIMI IIIA Effects of tPA on Coronary Lesions Primary Results BASELINE ANGIORAPHY: ANGIORAPHY AFTER tPA: ASA, IV Heparin, Beta-blockers, Nitrates, Ca++ blockers Randomize ETT 6 weeks Early Invasive: Cath 18-48 h PTCA/CABG prn 1473 Patients with Unstable Angina / NQWMI Early Conservative: ST Holter, ETT Thallium Cath/PTCA if +ischemia 1o Endpoint Inv-Cons: Death, MI, Positive ETT - 6 weeks Follow-up 1 year Circulation 1994;89:1545-56 2x2 Factorial: t-PA vs. Placebo 1o Endpoint t-PA: Death, MI, Rec Isch, + ETT, Thallium or ST Holter TIMI IIIB Protocol Design TIMI IIIB Investigators. Circulation 1994;89:1545-56 TIMI IIIB tPA vs. Placebo in Non-ST Elevation ACS Primary Results Composite Endpoint Death or MI ICH % of Patients P = NS P = 0.05 P = 0.05 Events at 42d Invasive Conservative p value 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)