N Engl J Med September 03, 1992

Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial

Pfeffer MA, Braunwald E, Moyé LA, et al.

Bottom Line

In asymptomatic patients with left ventricular dysfunction following a myocardial infarction, long-term administration of the ACE inhibitor captopril significantly reduced all-cause mortality, recurrent infarction, and the development of severe heart failure.

Key Findings

1. Captopril significantly reduced all-cause mortality, which occurred in 228 patients (20%) in the captopril arm compared to 275 patients (25%) in the placebo arm, reflecting a 19% reduction in relative risk (95% CI, 3 to 32%; P=0.019).
2. Cardiovascular mortality was decreased by 21% in the captopril group (95% CI, 5 to 35%; P=0.014).
3. The risk of developing severe heart failure was substantially reduced by 37% (95% CI, 20 to 50%; P<0.001) among patients receiving captopril.
4. Captopril use led to a 22% relative risk reduction for congestive heart failure hospitalizations (95% CI, 4 to 37%; P=0.019).
5. Patients in the captopril group experienced a 25% lower risk of recurrent myocardial infarction compared to placebo (95% CI, 5 to 41%; P=0.015).

Study Design

Design
Randomized Controlled Trial
Double-Blind
Sample
2,231
Patients
Duration
42 months
Median
Setting
Multicenter, US and Canada
Population Patients aged 21 to 80 years, 3 to 16 days post-myocardial infarction, with a left ventricular ejection fraction ≤40% and no overt heart failure or symptoms of ongoing myocardial ischemia.
Intervention Captopril, initiated at 6.25 mg or 12.5 mg and titrated up to a target dose of 50 mg three times daily.
Comparator Matching placebo.
Outcome All-cause mortality.

Study Limitations

The trial excluded patients with overt, symptomatic heart failure at baseline, as these patients already had an established clinical indication for ACE inhibition, focusing the findings specifically on asymptomatic left ventricular dysfunction.
Background medical therapy reflects the era of the early 1990s; concurrent use of beta-blockers, statins, and antiplatelet regimens was much lower than modern standard-of-care, potentially altering the absolute benefit seen today.
Captopril was administered up to three times daily, a dosing frequency that poses greater medication adherence challenges compared to the once-daily ACE inhibitors used in contemporary practice.
Patients older than 80 years of age and those with significant baseline renal impairment (serum creatinine >2.5 mg/dL) were excluded, limiting generalizability in these high-risk populations.

Clinical Significance

The SAVE trial was a pivotal landmark that established ACE inhibitors as a cornerstone of secondary prevention for post-MI patients with left ventricular systolic dysfunction. It demonstrated that initiating captopril early and maintaining it long-term mitigates adverse cardiac remodeling, delays the onset of symptomatic heart failure, and significantly extends survival even in patients who are initially asymptomatic.

Historical Context

Prior to the SAVE trial, ACE inhibitors were predominantly reserved for patients suffering from severe, symptomatic heart failure or resistant hypertension. Supported by preclinical models showing that early ACE inhibition could prevent pathological ventricular enlargement (remodeling) after coronary occlusion, SAVE tested this hypothesis in humans. Published in 1992 during an era that also produced the SOLVD and CONSENSUS trials, SAVE helped shift the cardiology paradigm toward early, proactive neurohormonal blockade to alter the disease trajectory in high-risk cardiovascular patients.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

By what physiological mechanism does captopril prevent the progression to overt heart failure in patients with asymptomatic left ventricular dysfunction post-myocardial infarction?

Key Response

Post-MI, the loss of functional myocardium triggers compensatory neurohormonal activation, notably the Renin-Angiotensin-Aldosterone System. Angiotensin II drives maladaptive ventricular remodeling, including hypertrophy, dilation, and fibrosis. By inhibiting ACE, captopril decreases Angiotensin II levels, thereby reducing afterload and directly mitigating this adverse structural remodeling, which preserves left ventricular geometry and function.

Resident
Resident

Based on the SAVE trial, if you are managing an asymptomatic patient 4 days post-MI with an ejection fraction of 35%, how should you adjust their medications and what specific laboratory monitoring is necessary?

Key Response

The SAVE trial proved that asymptomatic post-MI patients with an EF of 40% or less benefit from ACE inhibition to prevent future heart failure and death. The resident must initiate an ACE inhibitor like captopril. Crucially, this requires close monitoring of basic metabolic panels to watch for acute kidney injury and hyperkalemia, as ACE inhibitors decrease efferent arteriolar tone and reduce aldosterone secretion, posing risks to borderline hemodynamically stable post-MI patients.

Fellow
Fellow

The SAVE trial demonstrated an unexpected secondary outcome of reduced recurrent myocardial infarction rates. Given that ACE inhibitors are primarily vasodilators, what are the advanced mechanistic theories explaining this anti-ischemic benefit?

Key Response

While initially surprising, the reduction in recurrent MI is thought to be multifactorial. Mechanisms include improved endothelial function and vasodilation due to decreased bradykinin degradation, stabilization of atherosclerotic plaques by reducing Angiotensin II-mediated oxidative stress and inflammation, decreased sympathetic tone, and a reduction in myocardial oxygen demand secondary to diminished ventricular wall stress (Laplace's Law) from attenuated LV dilation.

Attending
Attending

While the SAVE trial established captopril's efficacy post-MI, modern practice utilizes agents like lisinopril or ramipril. How do you teach residents to critically evaluate when a drug-specific trial can be safely extrapolated as a class effect in cardiovascular medicine?

Key Response

This question prompts learners to differentiate between drug-specific and class effects. Attending physicians should teach that subsequent trials (such as AIRE for ramipril and TRACE for trandolapril) were needed to confirm that mortality benefit post-MI is indeed a neurohormonal class effect of ACE inhibitors. We now use newer agents primarily for their longer half-lives and once-daily dosing, which drastically improves patient adherence compared to the TID dosing of captopril used in SAVE.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The SAVE trial utilized a placebo-controlled design to evaluate captopril. How does the ethical impossibility of using a placebo control in modern post-MI HFrEF populations alter the statistical approach and sample size requirements for contemporary cardiovascular trials?

Key Response

Because SAVE and similar trials established RAAS blockade as the standard of care, modern trials cannot ethically withhold this therapy. Consequently, new interventions must be tested on top of guideline-directed medical therapy (active comparator). This requires massive sample sizes to detect increasingly marginal incremental benefits (superiority) or relies on complex non-inferiority designs with carefully justified margins, making modern trial execution statistically and logistically much more challenging.

Journal Editor
Journal Editor

As a peer reviewer evaluating the SAVE trial today, how would you critique the deliberate exclusion of patients with baseline severe renal dysfunction or overt heart failure regarding the study's external validity?

Key Response

A stringent reviewer would highlight that while the exclusion criteria maximized internal validity and safety by avoiding patients at highest risk for captopril-induced AKI or hyperkalemia, it severely limits external validity. The results cannot be universally applied to the sickest post-MI patients with cardiorenal syndrome, requiring editors to ensure the authors strictly confine their clinical claims to stable, asymptomatic individuals with mild-to-moderate LV dysfunction.

Guideline Committee
Guideline Committee

How did the findings of the SAVE trial directly shape current ACC/AHA guidelines for the management of patients following an acute myocardial infarction, and what is the specific Class and Level of Evidence for this intervention?

Key Response

The SAVE trial is a foundational pillar that led to the ACC/AHA guideline assigning a Class I, Level of Evidence A recommendation for the initiation of ACE inhibitors in all post-MI patients with a reduced ejection fraction (less than or equal to 40%). By demonstrating that early intervention in asymptomatic patients prevents fatal and non-fatal heart failure events, SAVE fundamentally shifted guidelines toward proactive neurohormonal blockade rather than purely symptom-reactive management.

Clinical Landscape

Noteworthy Related Trials

1993

AIRE Trial

n = 2,006 · Lancet

Tested

Ramipril

Population

Patients with clinical evidence of heart failure after acute myocardial infarction

Comparator

Placebo

Endpoint

All-cause mortality

Key result: Ramipril significantly reduced all-cause mortality by 27 percent compared to placebo.
1995

TRACE Trial

n = 1,749 · NEJM

Tested

Trandolapril

Population

Patients with left ventricular dysfunction following acute myocardial infarction

Comparator

Placebo

Endpoint

All-cause mortality

Key result: Trandolapril significantly reduced overall mortality and the risk of progression to severe heart failure.
2003

VALIANT Trial

n = 14,703 · NEJM

Tested

Valsartan, captopril, or the combination of both

Population

Patients with heart failure or left ventricular dysfunction after myocardial infarction

Comparator

Captopril

Endpoint

All-cause mortality

Key result: Valsartan was non-inferior to captopril in reducing mortality, but combining both increased adverse events without further survival benefit.

Tailored to your role

Want this tailored to you?

Add your specialty or training stage to get role-specific takeaways and more questions.

Personalize this analysis