Valsartan in Acute Myocardial Infarction trial (VALIANT): Rationale and design

Background survivors of acute myocardial infarction (MI) complicated by hea rt failure and/or resulting in left ventricular dysfunction are at heighten ed risk for subsequent death and major nonfatal cardiovascular events. Inhi bition of the renin-angiotensin system with an angiotensin-converting enzym e inhibitor has consistently been demonstrated to result in reductions in t hese risks by approximately 20%. The development of angiotensin II receptor blockers offers a new, more specific, and theoretically more complete phar macologic 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 comparin g the efficacy and safety of long-term treatment with valsartan, captopril, and their combination in high-risk patients after MI. The trial is designe d with 3 arms, giving equal statistical consideration to survival compariso ns of captopril versus the angiotensin II receptor blocker valsartan, as we ll as the combination of captopril plus valsartan, compared with a proven e ffective dose of captopril. This 14,500-patient trial is designed with an 8 6% power to detect a 15% reduction in mortality rate with either use of val sartan compared with captopril. The trial encourages optimal individualizat ion of other proven therapies in acute and chronic infarction, and the inte rnational patient body ensures good representation of multiple practice pat terns. Conclusion VALIANT ii a large international investigative effort that will evaluate the role of valsartan in the menage ment of patients with MI assoc iated 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 angiotens in II receptor blocker can make an additional improvement in clinical outco mes beyond angiotensin-converting enzyme inhibitors.