Clinical trials update: OPTIME-CHF, PRAISE-2, ALL-HAT

This is a summary of reports of presentation made at the American College o f Cardiology 49th Scientific Sessions, Anaheim, 12-15 March 2000. Studies w ith a particular interest for heart failure physicians have been reviewed. OPTIME-CHF: Outcomes of a Prospective Trial of Intravenous Milrinone for Ex acerbations of Chronic Heart Failure. OPTIME-CHF was a randomised-controlle d trial comparing a 48-h infusion of milrinone or standard therapy in 951 p atients recruited over a 2-year period. Patients were excluded if the inves tigator believed their clinical condition mandated inotropic therapy. Patie nts were randomised within 48 h of admission for an acute exacerbation of c hronic heart failure to receive milrinone or placebo infision for 48 h. Of the patients 43% were diabetics, 70% were receiving an angiotensin converti ng enzyme inhibitor, 25% were already on a beta-blocker, and 34% had atrial fibrillation. There was no significant difference between the two groups i n length of hospital stay during the index admission, subsequent readmissio ns and days in hospital over the following 60 days. Subjective clinical ass essment scores were also no different. There was an average admission rate over the next year of one per patient in both groups. However, there was a significant increase in the incidence of sustained hypotension in the milri none group, which accounted for all of the increased adverse event rates fo r the active therapy. The 60-day mortality was 10% in both groups. This and previous trials of the oral formulation of milrinone have now clearly demo nstrated a lack of benefit with milrinone in either during acute exacerbati ons of or in stable severe chronic heart failure [Packer M, Carver JR, Rode heffer RJ et al. Effect of oral milrinone on mortality in severe chronic he art failure. N Engl J Med 1991;325:1468-1475.]. Medium sized studies of mil rinone in patients with milder severities of heart failure also suggested a n adverse impact on prognosis in the presence or absence of digoxin [DiBian co R, Shabetai R, Kostuk W, Moran J, Schlant RC, Wright R. A comparison of oral milrinone, digoxin, and their combination in the treatment of patients with chronic heart failure. N Engl J Med 1989;320:677-683.]. Whether milri none even has a role for the management of a haemodyamic crisis requiring i notropic therapy must also be questioned. (C) 2000 European Society of Card iology. All rights reserved.