The New England Journal of Medicine JANUARY 20, 2000

Effects of an Angiotensin-Converting-Enzyme Inhibitor, Ramipril, on Death from Cardiovascular Causes, Myocardial Infarction, and Stroke in High-Risk Patients

The Heart Outcomes Prevention Evaluation (HOPE) Study Investigators

Bottom Line

The HOPE trial demonstrated that the ACE inhibitor ramipril significantly reduced the composite risk of cardiovascular death, myocardial infarction, and stroke in high-risk patients with established vascular disease or diabetes, independent of its blood-pressure-lowering effects.

Key Findings

1. The primary composite endpoint (cardiovascular death, myocardial infarction, or stroke) was reduced by 22% in the ramipril group compared to placebo (14.0% vs. 17.8%; hazard ratio 0.78, 95% CI 0.70–0.86, p < 0.001).
2. Individual components of the primary endpoint were significantly reduced: cardiovascular death by 26% (RR 0.74, p < 0.001), myocardial infarction by 20% (RR 0.80, p < 0.001), and stroke by 32% (RR 0.68, p < 0.001).
3. Ramipril reduced the risk of all-cause mortality (RR 0.84, p = 0.005) and the need for revascularization procedures (RR 0.85, p = 0.002).
4. In the diabetic subgroup (n=3,577), ramipril lowered the primary composite outcome by 25% (RR 0.75, 95% CI 0.64–0.88, p = 0.0004), a benefit that remained significant after adjusting for blood pressure changes.
5. The benefit of ramipril was observed to be independent of its modest effect on lowering blood pressure (average reduction of 3/1 mmHg systolic/diastolic).

Study Design

Design
RCT
Double-Blind
Sample
9,297
Patients
Duration
4.5 yr
Median
Setting
Multicenter, International
Population Patients aged 55 years or older with evidence of vascular disease (coronary artery, peripheral vascular, or cerebrovascular disease) or diabetes plus at least one other cardiovascular risk factor, and without heart failure or known low ejection fraction.
Intervention Ramipril 10 mg daily
Comparator Matching placebo
Outcome Composite of cardiovascular death, myocardial infarction, or stroke

Study Limitations

The study did not evaluate the effect of ramipril in lower-risk populations, limiting the generalizability of these findings to those without established vascular disease or high-risk diabetes.
The trial was terminated early (after 4.5 years instead of the planned 5 years) due to consistent, clear benefit, which can sometimes lead to an overestimate of effect sizes in trials.
While the benefit in diabetic patients was significant, the study may have been underpowered to detect differing effects across specific diabetes-related subgroups.
The high rate of permanent study medication discontinuation (approx. 29% in the ramipril group, largely due to cough) reflects real-world challenges in ACE inhibitor tolerance.

Clinical Significance

The HOPE trial revolutionized the management of high-risk cardiovascular patients by establishing that ACE inhibitors provide substantial vasculoprotective benefits beyond simple blood pressure reduction, becoming a cornerstone therapy for secondary prevention in patients with stable cardiovascular disease or high-risk diabetes.

Historical Context

Published at the turn of the millennium, the HOPE study challenged the traditional paradigm that the protective effects of ACE inhibitors were primarily dependent on blood pressure lowering. By demonstrating benefit in patients who were largely normotensive, it shifted clinical practice toward the use of ACE inhibitors as a broad vascular-protective strategy for high-risk patients, rather than solely for treating heart failure or hypertension.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

What is the physiological mechanism by which ACE inhibitors like ramipril provide cardioprotection beyond simple blood pressure reduction?

Key Response

Ramipril inhibits the conversion of Angiotensin I to Angiotensin II, which not only reduces systemic vasoconstriction but also prevents the degradation of bradykinin. This leads to increased nitric oxide production, improved endothelial function, and the prevention of adverse cardiac and vascular remodeling, which are critical for high-risk patients regardless of their baseline blood pressure.

Resident
Resident

A 62-year-old patient with established peripheral artery disease has a baseline blood pressure of 122/76 mmHg. Based on the HOPE trial findings, should you initiate ACE inhibitor therapy, and what is the clinical rationale?

Key Response

Yes. The HOPE trial demonstrated that ramipril significantly reduces the risk of cardiovascular death, MI, and stroke in high-risk patients with vascular disease even if they are normotensive at baseline. This shifts the clinical focus from treating a 'number' (hypertension) to managing 'risk' (secondary prevention of vascular events).

Fellow
Fellow

The HOPE trial reported a significant 34% reduction in the development of new-onset diabetes in the ramipril group. What are the hypothesized metabolic mechanisms behind this observation?

Key Response

ACE inhibition is thought to improve insulin sensitivity by enhancing bradykinin-mediated blood flow to skeletal muscle and inhibiting the pro-inflammatory effects of Angiotensin II. Angiotensin II also interferes with the insulin signaling pathway (PI3K-Akt); by blocking it, ACE inhibitors may preserve beta-cell function and insulin responsiveness.

Attending
Attending

In the context of the HOPE trial, why is the specific dose of 10mg of ramipril considered the 'gold standard' for secondary prevention, and how does this impact your approach to patients who tolerate lower doses?

Key Response

The HOPE trial utilized a target dose of 10mg daily to achieve significant outcomes. Many clinicians under-dose ACE inhibitors in practice; however, the benefit seen in HOPE is dose-dependent regarding tissue-level ACE inhibition. Attending physicians should emphasize titrating to the trial-proven dose of 10mg unless limited by adverse effects like hyperkalemia or renal dysfunction.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The HOPE trial utilized a 2x2 factorial design to test ramipril and Vitamin E. What are the statistical implications if a significant interaction between these two interventions had been detected?

Key Response

A 2x2 factorial design assumes that the effects of the two treatments are independent (no interaction). If a significant interaction existed, the 'marginal' analysis (comparing all ramipril vs. all placebo) would be misleading, as the effect of ramipril would depend on whether the patient was also receiving Vitamin E, requiring a 'simple' effects analysis of the four individual cells.

Journal Editor
Journal Editor

The HOPE trial included a 2.5-week run-in period where patients received 2.5mg of ramipril and placebo. How does this design choice affect the internal validity and the external generalizability of the results?

Key Response

The run-in period improves internal validity by excluding non-compliant patients and those who develop immediate side effects (e.g., cough), thus maximizing the study's power to show an effect. However, it compromises external generalizability because the trial cohort is 'pre-screened' for tolerance, likely leading to a lower reported incidence of adverse events than would be seen in the general clinical population.

Guideline Committee
Guideline Committee

Based on the evidence from HOPE and subsequent trials, how should ACE inhibitor recommendations for patients with Stable Ischemic Heart Disease (SIHD) be graded in the presence of normal left ventricular function?

Key Response

The HOPE trial provided Class I, Level A evidence that ACE inhibitors should be started in all patients with SIHD who also have diabetes or chronic kidney disease. For those with SIHD and normal LV function/no other comorbidities, it remains a Class I (AHA/ACC) or IIa recommendation, as the trial clearly showed that high-risk vascular profiles derive mortality benefits independent of ejection fraction or hypertension status.

Clinical Landscape

Noteworthy Related Trials

2003

EUROPA Trial

n = 12,218 · Lancet

Tested

Perindopril 8mg daily

Population

Patients with stable coronary artery disease without clinical heart failure

Comparator

Placebo

Endpoint

Composite of cardiovascular mortality, nonfatal myocardial infarction, and cardiac arrest

Key result: Perindopril treatment resulted in a 20% relative risk reduction in the primary composite endpoint compared to placebo.
2007

ADVANCE Trial

n = 11,140 · Lancet

Tested

Fixed-dose combination of perindopril and indapamide

Population

Patients with type 2 diabetes

Comparator

Placebo

Endpoint

Composite of major macrovascular or microvascular events

Key result: Routine administration of a perindopril-indapamide combination significantly reduced the risk of major vascular events in patients with type 2 diabetes.
2008

ONTARGET Trial

n = 25,620 · NEJM

Tested

Telmisartan 80mg daily

Population

High-risk patients with vascular disease or high-risk diabetes

Comparator

Ramipril 10mg daily

Endpoint

Composite of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure

Key result: Telmisartan was found to be non-inferior to ramipril in preventing cardiovascular events, with better tolerability.

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