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Valsartan in acute myocardial infarction trial (VALIANT): rationale and design
M A Pfeffer1, J McMurray, A Leizorovicz
1Cardiovascular Division, Brigham and Women's Hospital, Boston, MA 02115, USA. mpfeffer@rics.bwh.harvard.edu
Insights
Survivors of heart attack with heart failure face increased risks. This study compares valsartan, an angiotensin II receptor blocker, with captopril, an ACE inhibitor, to improve outcomes.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Patients surviving acute myocardial infarction (MI) with heart failure or left ventricular dysfunction have a high risk of mortality and cardiovascular events.
- Angiotensin-converting enzyme (ACE) inhibitors reduce these risks by approximately 20%.
- Angiotensin II receptor blockers (ARBs) offer a targeted approach to inhibit angiotensin II's adverse effects.
Purpose of the Study:
- To evaluate the efficacy and safety of valsartan compared to captopril in high-risk post-MI patients.
- To assess the benefit of combining valsartan with captopril versus captopril alone.
Main Methods:
- The Valsartan in Acute Myocardial Infarction (VALIANT) trial was a multicenter, double-blind, randomized study.
- 14,500 high-risk post-MI patients were assigned to receive valsartan, captopril, or both.
- The study was powered to detect a 15% reduction in mortality with valsartan versus captopril.
Main Results:
- Results are not detailed in the provided abstract, but the study design aimed to compare survival rates between treatment groups.
Conclusions:
- The VALIANT trial investigates valsartan's role in managing MI patients with heart failure or left ventricular dysfunction.
- It tests whether ARBs like valsartan provide additional benefits beyond ACE inhibitors.
Background:
Survivors of acute myocardial infarction (MI) complicated by heart failure and/or resulting in left ventricular dysfunction are at heightened risk for subsequent death and major nonfatal cardiovascular events. Inhibition of the renin-angiotensin system with an angiotensin-converting enzyme inhibitor has consistently been demonstrated to result in reductions in these risks by approximately 20%. The development of angiotensin II receptor blockers offers a new, more specific, and theoretically more complete pharmacologic mode to inhibit the adverse influence of angiotensin II.
Methods:
Valsartan in Acute Myocardial Infarction (VALIANT) is a multicenter, double-blind, randomized, active controlled parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril, and their combination in high-risk patients after MI. The trial is designed with 3 arms, giving equal statistical consideration to survival comparisons of captopril versus the angiotensin II receptor blocker valsartan, as well as the combination of captopril plus valsartan, compared with a proven effective dose of captopril. This 14,500-patient trial is designed with an 86% power to detect a 15% reduction in mortality rate with either use of valsartan compared with captopril. The trial encourages optimal individualization of other proven therapies in acute and chronic infarction, and the international patient body ensures good representation of multiple practice patterns.
Conclusion:
VALIANT is a large international investigative effort that will evaluate the role of valsartan in the management of patients with MI associated with heart failure and/or left ventricular dysfunction. The use of a proven dose of captopril and the comparator arms with valsartan alone or in combination with captopril provides a unique test of whether the angiotensin II receptor blocker can make an additional improvement in clinical outcomes beyond angiotensin-converting enzyme inhibitors.