What is SAVE Trial?
Survival And Ventricular Enlargement Study Group.
Tell me about the trial in a brief paragraph? - Quick and Dirty.
Trial looked at capacity of Captopril to reduce the morbidity and mortality in patients with left ventricular failure after a heart attack.
So in short CAPTOPRIL (any ACE Inhibitor) reduces both morbidity and mortality for post-MI patients with asymptomatic heart failure per this trial.
Details of the Trial
Specialty: Cardiology (Heart Failure and MI)
Problem Addressed: Heart Failure (EF<40%) after Myocardial Infarction.
Design:
Randomized placebo controlled trial.
Patients:
Total - 2231 randomly selected 3 to 16 days after a MI. All with EF < 40% and no symptoms of heart failure - so Class 1 to 2.
1115 recieved Captopril
1116 rcieved placebo.
Inclusion Criteria:
Both sexes, 1987 to 1990 (January 27th to 28th).
(by MUGA)b/n 21 and 80 years of age
Exclusion Criteria:
Failure to randomize with in 16 days of MI
Serum Cr > 2.5
Contraindication or allergy to ACEI
Another reason to use the ACEI like HTN or CHF symptoms.
Unwillingness to participate.
Unstable course after MI
Recurrent ischemia with in 72 hour after MI or if they needed further ischemic w/u or treatment.
Average Follow-up: 42 months. Two weeks after randomization, then every three months for first year then every 4 months for second year.
REPEAT MUGA SCAN TO ASSES LV EJECTION FRACTION AT AN AVERAGE OF 36 MONTHS OF TIME.
Dosage:
Starting 6.25 to 12.5 tid and gradually increased to 25 tid at the time of discharge with a target dose of 50 tid. No BP guidelines were used for titration. Compliance was determined by pill count at follow up.
End Points:
Primary - All cause mortality - reduced by 5 percent (20 versus 25% in placebo.
Secondary - Risk Reductions:
Death from Cardiovascular Causes - 21% risk reduction.
CHF requiring hospitalization - 22% risk reduction
CHF requiring ACEI - 37% reduction
Recurrent MI - 25% reduction in risk
Death from CV causes or MI - 22% risk reduction
Death from Cv causes, CHf or MI - 24% risk reduction.
Conclusions:
In patient who had a recent MI addition of ACEI (Captopril) reduces all cause mortality and morbidity even on top of standard beta blockers, aspirin and nitrates.
Importance:
First trial to show mortality and morbidity reduction by ACEI in post-MI patient with LVEF of < 40% without HF symptoms.
For other ACEI trials please see the links for ACEI trials on the main cardiologytrials page @
http://cardiologytrials.blogspot.com
Here are some images and links:
PUBMED LINK HERE
NEJM LINK HERE
Survival And Ventricular Enlargement Study Group.
Tell me about the trial in a brief paragraph? - Quick and Dirty.
Trial looked at capacity of Captopril to reduce the morbidity and mortality in patients with left ventricular failure after a heart attack.
So in short CAPTOPRIL (any ACE Inhibitor) reduces both morbidity and mortality for post-MI patients with asymptomatic heart failure per this trial.
Details of the Trial
Specialty: Cardiology (Heart Failure and MI)
Problem Addressed: Heart Failure (EF<40%) after Myocardial Infarction.
Design:
Randomized placebo controlled trial.
Patients:
Total - 2231 randomly selected 3 to 16 days after a MI. All with EF < 40% and no symptoms of heart failure - so Class 1 to 2.
1115 recieved Captopril
1116 rcieved placebo.
Inclusion Criteria:
Both sexes, 1987 to 1990 (January 27th to 28th).
(by MUGA)b/n 21 and 80 years of age
Exclusion Criteria:
Failure to randomize with in 16 days of MI
Serum Cr > 2.5
Contraindication or allergy to ACEI
Another reason to use the ACEI like HTN or CHF symptoms.
Unwillingness to participate.
Unstable course after MI
Recurrent ischemia with in 72 hour after MI or if they needed further ischemic w/u or treatment.
Average Follow-up: 42 months. Two weeks after randomization, then every three months for first year then every 4 months for second year.
REPEAT MUGA SCAN TO ASSES LV EJECTION FRACTION AT AN AVERAGE OF 36 MONTHS OF TIME.
Dosage:
Starting 6.25 to 12.5 tid and gradually increased to 25 tid at the time of discharge with a target dose of 50 tid. No BP guidelines were used for titration. Compliance was determined by pill count at follow up.
End Points:
Primary - All cause mortality - reduced by 5 percent (20 versus 25% in placebo.
Secondary - Risk Reductions:
Death from Cardiovascular Causes - 21% risk reduction.
CHF requiring hospitalization - 22% risk reduction
CHF requiring ACEI - 37% reduction
Recurrent MI - 25% reduction in risk
Death from CV causes or MI - 22% risk reduction
Death from Cv causes, CHf or MI - 24% risk reduction.
Conclusions:
In patient who had a recent MI addition of ACEI (Captopril) reduces all cause mortality and morbidity even on top of standard beta blockers, aspirin and nitrates.
Importance:
First trial to show mortality and morbidity reduction by ACEI in post-MI patient with LVEF of < 40% without HF symptoms.
For other ACEI trials please see the links for ACEI trials on the main cardiologytrials page @
http://cardiologytrials.blogspot.com
Here are some images and links:
PUBMED LINK HERE
NEJM LINK HERE
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