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Quinapril Ischemic Event Trial - QUIET
Description:
The Quinapril Ischemic Event Trial (QUIET) was a randomized, multicenter, placebo-controlled trial designed to study whether the angiotensin-converting enzyme (ACE) inhibitor quinapril would reduce adverse cardiac events in patients with ischemic heart disease and preserved left ventricular (LV) function.
Hypothesis:
Compared to placebo, quinapril 20 mg/day would reduce ischemic events and the angiographic progression of coronary artery disease in patients with angiographically documented ischemic heart disease, but without LV systolic dysfunction.
Study Design
Study Design:
Patients Enrolled: 1,750
Mean Follow Up: mean 27 months
Mean Patient Age: mean 58
Female: 18
Mean Ejection Fraction: LVEF >40
Patient Populations:
Patients 18 to 75 years of age who had undergone successful coronary angioplasty or atherectomy at baseline (prior to randomization), and had at least one coronary artery that had not been subjected to mechanical revascularization
Exclusions:
Low-density lipoprotein >165 mg/dl; coronary artery bypass graft surgery; systolic blood pressure <100 mm Hg or >160 mm Hg and/or diastolic blood pressure >100 mm Hg; LV ejection fraction (LVEF) <40%; MI within seven days; prior angioplasty within three months; and patients receiving lipid-lowering medications, ACE inhibitors, or calcium channel blockers
Primary Endpoints:
Time to first cardiac event (cardiac death, resuscitated cardiac arrest, nonfatal MI, coronary artery bypass surgery, coronary angioplasty, or hospitalization for angina pectoris)
Secondary Endpoints:
Time to first major cardiac event (cardiac death, resuscitated cardiac arrest, or nonfatal MI); time to first cardiac event in the first six months; and time to first cardiac event in months 7-36
Drug/Procedures Used:
Quinapril 20 mg/day or placebo. Quinapril at 10 mg/day or placebo was started within 12-72 hours of baseline angiogram and angioplasty. The study medication was doubled the next day (for a total of quinapril 20 mg/day).
Concomitant Medications:
No ACE inhibitors, calcium channel blockers, or lipid-lowering medications
Principal Findings:
A total of 1,750 patients were enrolled. Baseline characteristics were well-balanced between the study arms; the mean duration of follow-up was 27 months. The time to first ischemic event was similar in both treatment groups, and the frequency of cardiac events was 38% in both groups (p=0.6).
There was no difference between groups in early or late major cardiac events or all-cause mortality. There was no difference in the incidence of percutaneous transluminal coronary angioplasty in the groups, except for new (previously unintervened) vessels, which was decreased in the quinapril arm (79 events vs. 114 in the placebo arm, p=0.018). In the angiographic substudy of 477 patients, 47% of the quinapril-treated patients versus 49% of the placebo-treated patients had progression of disease (p=0.71).
Interpretation:
In this large randomized trial, treatment of patients with preserved LV function and ischemic heart disease with quinapril 20 mg/day was not associated with a decrease in ischemic events or progression of disease at two years. This result stands in contrast to the larger HOPE study, which demonstrated a reduction in events with the ACE inhibitor ramipril during a mean five-year follow-up period. Whether this was related to a difference between the two agents, an inadequate dose of quinapril in the study, or the duration of follow-up in this trial is unclear.
References:
Pitt B, O'Neill B, Feldman R, et al., for the QUIET Study Group. The QUinapril Ischemic Event Trial (QUIET): evaluation of chronic ACE inhibitor therapy in patients with ischemic heart disease and preserved left ventricular function. Am J Cardiol 2001;87:1058-63.
Keywords: Isoquinolines, Coronary Artery Disease, Follow-Up Studies, Atherectomy, Tetrahydroisoquinolines, Ramipril, Angioplasty, Balloon, Coronary
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