OPTIMAAL研究PPT课件

OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - SUMMARY -
In patients with acute MI and evidence of heart failure or left ventricular dysfunction, losartan 50 mg daily:
• Mortality curves separated early on and then largely remained parallel
• Nonsignificant difference in favor of captopril in: — Sudden cardiac death or resuscitated cardiac arrest — Fatal or nonfatal reinfarction — All-cause hospitalization
Male (%)
History
Hypertension (%) Previous MI (%)
Mean BP (mmHg) Systolic Diastolic
Medications
Thrombolytic (%) Beta-blocker (%) Aspirin (%) Statin (%)
Time to randomization (h)
The three major endpoints
All-cause mortality
Sudden cardiac death or resuscitated cardiac arrest
Myocardial reinfarction (fatal or nonfatal)
Captopril (n=2733) No. (%)
Follow up and primary endpoint Primary endpoint: all-cause mortality. Mean 2.7 years follow up
Treatment Captopril (titrated to target dose 50 mg three times daily, as tolerated) or losartan (titrated to target 50 mg daily, as tolerated)
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan
Purpose To determine whether the angiotensin II receptor blocker losartan is superior or inferior to the angiotensin converting enzyme (ACE) inhibitor captopril in reduction of all-cause mortality in high-risk patients after acute MI
Secondary and tertiary endpoints
Endpoint 15 rate (%)
10
Sudden cardiac death or cardiac arrest
5
0
15
Reinfarction
10
5
0 0
6
12 18 24 30 36
Months after randomization
Reference Dickstein K, Kjekshus J and the OPTIMAAL Steering Committee, for the OPTIMAAL Study Group. Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomised trial. Lancet 2002;360:752–60.
Captopril (n=2744)
67
1.4
55 78 96 31
85
Losartan (n=2733)
67
72
36 18
123.0 71.5
54 79 95 30
84.9
All (n=5477)
67
71
36 18
122.8 71.4
54 79 96 31
84.9
Dickstein et al. Lancet 2002; 360:752–60.
• Losartan better tolerated than captopril as defined by permanent discontinuation of drug (17 vs. 23%, hazard ratio 0.70, 95% CI 0.62–0.79, P<0.0001)
Captopril Losartan
RR 1.13 (95% CI 0.99–1.28)
P= 0.069
6
12 18 24 30 36
Months after randomization
Dickstein et al. Lancet 2002; 360:752–60.
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - RESULTS continued -
RR 1.19 (95% CI 0.98–1.43) P = 0.072
RR 1.03 (95% CI 0.89–1.18) P = 0.72
Captopril Losartan
Dickstein et al. Lancet 2002; 360:752–60.
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - RESULTS continued -
Patients 5466 patients aged >50 years with acute MI and evidence of heart failure or left ventricular dysfunction (left ventricular ejection fraction <35%)
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - RESULTS -
• All-cause mortality nonsignificantly higher in losartan group compared with captopril (18.2 vs. 16.4%, P=0.069)
• Conferred no benefit in comparison with captopril • Was better tolerated than captopril
ACE inhibitors therefore remain the first-choice therapy in this group
447 (16.4) 203 (7.4)
379 (13.9)
Losartan (n=2744) No. (%)
499 (18.2) 239 (8.7)
Relative risk (95% CI)
1.13 (0.99–1.28) 1.19 (0.99–1.43)
384 (14) 1.03 (0.89–1.18)
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - RESULTS continued -
Mortality 25 (%) 20
15
10
5
0 0
All-cause mortality
Hospitalization 80 (%)
60
All-cause hospitalization
40
20
0 0
Captopril Losartan
RR 1.03 (95% CI 0.97–1.10)
P = 0.36
6
12 18 24 30 36
Months after randomization
Dickstein et al. Lancet 2002; 360:752–60.
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - TRIAL DESIGN continued-
Baseline characteristics
Mean age (years)
P
0.069 0.072 0.722
Dickstein et al. Lancet 2002; 360:752–60.
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - RESULTS continued -
OPTIMAAL: Optimal Trial In Myocardial Infarction with the Angiotensin Antagonist Losartan - TRIAL DESIGN -
Design Multicenter, multinational, randomized, double-blind, parallel-group