Randomized Trial of Randomized Trial of Intervention vs - PowerPoint PPT Presentation

British Heart Foundation RITA-3 Trial RITA- -3 3 RITA Randomized Trial of Randomized Trial of Intervention vs Conservative Intervention vs Conservative Therapy in Unstable Angina/ Therapy in Unstable Angina/ Non- -ST Elevation MI ST Elevation MI Non Keith A A Fox on behalf of the Executive Committee and Investigators of RITA-3 ESC Hotline 2002

RITA- -3 3 RITA RITA 3 Study Design RITA 3 Study Design Follow-up & endpoints 4 PCI/CABG Intervention Angio N = 1810 N = 895 months, 1 year Medical Rx UA or Aspirin NSTEMI Enoxaparin Baseline Baseline Conservative Medical Rx enzymes, enzymes, markers markers +ischemia +ischemia N = 915 Angio/PCI/CABG Chest pain Randomization 0 h 72 h - 48hr ESC Hotline 2002

RITA- -3 3 RITA Baseline ECG, Enzymes & Baseline ECG, Enzymes & Troponin Troponin Intervention Conservative Intervention Conservative ECG abnormal 92 93 ST � or � * >0.1mV 42 40 T � 70 74 LBBB 4 3 Enzyme/marker � CK � 2 fold 17 19 Troponin � 78 71 Inclusion: troponin+ only 2 2 CK & troponin normal 10 9 All data given as percentages. *Transient elevation. ESC Hotline 2002

RITA- RITA- -3 -3 3 3 Timing of first arteriogram arteriogram RITA RITA Timing of first randomization to 1 year randomization to 1 year 97% 97% Intervention 100 97% 97% 90 Cumulative percentage 80 70 60 Conservative 50 49% 49% 40 16% 16% 30 20 10 0 0 2 4 6 8 10 12 Time since randomisation (months) ESC Hotline 2002

RITA- RITA- -3 -3 3 3 Timing of first revascularisation revascularisation RITA RITA Timing of first randomization to 1 year randomization to 1 year Intervention 57.6% 60 57.6% Cumulative percentage 50 40 Conservative 30 28.3% 28.3% 20 10 0 0 2 4 6 8 10 12 Time since randomisation (months) ESC Hotline 2002

Cumulative risk of death, MI Cumulative risk of death, MI RITA- RITA- -3 -3 3 3 RITA RITA or refractory angina or refractory angina 20 Conservative 18 14.5% Cumulative percentage 16 Intervention 14 12 10 8 p = 0.001 9.6% 6 Risk ratio = 0.66 4 (95% CI 0.51–0.85) 2 0 0 4 12 Time since randomisation (months) ESC Hotline 2002

Death, MI or Refractory Angina Death, MI or Refractory Angina RITA- -3 3 RITA at 4 Months at 4 Months Outcome Intervention Conservative Risk ratio P value n=895 (%) n=915 (%) (95% CI) Death 2.9 2.5 1.16 0.61 (0.66–2.01) MI 3.4 3.7 0.90 0.68 (0.56–1.46) RA 4.4 9.3 <0.001 0.47 (0.32–0.68) Death/MI/RA 9.6 14.5 0.001 0.66 (0.51–0.85) Death/MI 5.6 5.8 0.96 0.85 (0.66–1.40) ESC Hotline 2002

RITA- -3 3 RITA Overall Death or MI Overall Death or MI 3646 Patient Years of Follow- -up up 3646 Patient Years of Follow Intervention Conservative Hazard ratio Outcome n=895 (%) n=915 (%) (95% CI) Death 6.7 7.8 MI 5.0 6.1 0.83 Death/MI 10.6 12.9 n=118 (0.63–1.09) n=95 ESC Hotline 2002

RITA- -3 3 RITA Angina During Follow- -up up Angina During Follow 0.75 Any angina 4 months 0.80 Any angina 1 year 0.72 Grade 2+ 4 months 0.75 Grade 2+ 1 year 0.72 Grade 3+ 4 months 0.75 Grade 3+ 1 year 0.5 0.6 0.7 0.8 0.9 1 ESC Hotline 2002

RITA- -3 3 RITA Conclusions Conclusions A strategy of intervention in moderate-risk patients: • Results in fewer deaths/MIs/refractory angina events – principal impact on refractory angina • Decreases the incidence of subsequent angina – especially rest and severe angina • Decreases the need for subsequent anti-anginal therapy • Improves quality of life ESC Hotline 2002