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

RITA RITA-

• 3

3

ESC Hotline 2002

Randomized Trial of Randomized Trial of Intervention vs Conservative Intervention vs Conservative Therapy in Unstable Angina/ Therapy in Unstable Angina/ Non Non-

• ST Elevation MI

ST Elevation MI

Keith A A Fox

• n behalf of the Executive Committee

and Investigators of RITA-3

British Heart Foundation RITA-3 Trial

RITA RITA-

• 3

3

ESC Hotline 2002

RITA 3 Study Design RITA 3 Study Design

Randomization Chest pain

• 48hr

72 h 0 h

UA or NSTEMI Intervention Conservative PCI/CABG Angio/PCI/CABG Medical Rx Medical Rx Follow-up & endpoints 4 months, 1 year Aspirin Enoxaparin Angio

+ischemia +ischemia Baseline Baseline enzymes, enzymes, markers markers

N = 895 N = 915 N = 1810

RITA RITA-

• 3

3

ESC Hotline 2002

Baseline ECG, Enzymes & Baseline ECG, Enzymes & Troponin Troponin

10 9 CK & troponin normal 2 2 Inclusion: troponin+ only 78 71 Troponin 17 19 CK 2 fold Enzyme/marker 4 3 LBBB 70 74 T 42 40 ST or * >0.1mV 92 93 ECG abnormal Conservative Conservative Intervention Intervention

All data given as percentages. *Transient elevation.

RITA RITA-

• 3

3

ESC Hotline 2002

Timing of first Timing of first arteriogram arteriogram

randomization randomization to 1 year to 1 year

RITA RITA-

• 3

3

Cumulative percentage Time since randomisation (months) 2 4 6 8 10 12 10 20 30 40 50 60 70 80 90 100 Conservative Intervention

97% 97% 49% 49% 97% 97% 16% 16%

RITA RITA-

• 3

3

ESC Hotline 2002

Timing of first Timing of first revascularisation revascularisation

randomization randomization to 1 year to 1 year

RITA RITA-

• 3

3

Cumulative percentage Time since randomisation (months) 2 4 6 8 10 12 10 20 30 40 50 60 Conservative Intervention 57.6%

57.6% 28.3% 28.3%

RITA RITA-

• 3

3

ESC Hotline 2002

Cumulative risk of death, MI Cumulative risk of death, MI

• r refractory angina
• r refractory angina

RITA RITA-

• 3

3

Cumulative percentage Time since randomisation (months) 4 12 2 4 6 8 10 12 14 16 18 20 Conservative Intervention

p = 0.001 Risk ratio = 0.66 (95% CI 0.51–0.85) 14.5% 9.6%

RITA RITA-

• 3

3

ESC Hotline 2002

Death, MI or Refractory Angina Death, MI or Refractory Angina at 4 Months at 4 Months

0.85 0.96 (0.66–1.40) 5.8 5.6 Death/MI 0.001 0.66 (0.51–0.85) 14.5 9.6 Death/MI/RA <0.001 0.47 (0.32–0.68) 9.3 4.4 RA 0.68 0.90 (0.56–1.46) 3.7 3.4 MI 0.61 1.16 (0.66–2.01) 2.5 2.9 Death

P value Risk ratio (95% CI) Conservative n=915 (%) Intervention n=895 (%)

Outcome

RITA RITA-

• 3

3

ESC Hotline 2002

Overall Death or MI Overall Death or MI

3646 Patient Years of Follow 3646 Patient Years of Follow-

• up

up

0.83 (0.63–1.09) 12.9 10.6 Death/MI 6.1 5.0 MI 7.8 6.7 Death

Hazard ratio (95% CI) Conservative n=915 (%) Intervention n=895 (%)

Outcome n=95 n=118

RITA RITA-

• 3

3

ESC Hotline 2002

Angina During Follow Angina During Follow-

• up

up

Any angina 4 months Any angina 1 year Grade 2+ 4 months Grade 2+ 1 year Grade 3+ 4 months Grade 3+ 1 year 0.5 1 0.72 0.72 0.80 0.75 0.75 0.75 0.6 0.7 0.8 0.9

RITA RITA-

• 3

3

ESC Hotline 2002

Conclusions Conclusions

• 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

A strategy of intervention in moderate-risk patients: