R. Scognamiglio et al., NIFEDIPINE IN ASYMPTOMATIC PATIENTS WITH SEVERE AORTIC REGURGITATION AND NORMAL LEFT-VENTRICULAR FUNCTION, The New England journal of medicine, 331(11), 1994, pp. 689-694
Background. Vasodilator therapy with nifedipine reduces left ventricul
ar volume and mass and increases the ejection fraction in asymptomatic
patients with severe aortic regurgitation. Methods. To assess whether
vasodilator therapy reduces or delays the need for valve replacement,
we randomly assigned 143 asymptomatic patients with isolated, severe
aortic regurgitation and normal left ventricular systolic function to
receive either nifedipine (20 mg twice dally, 69 patients) or digoxin
(0.25 mg daily, 74 patients). Results. By actuarial analysis, we deter
mined that after six years a mean (+/-SD) of 34+/-6 percent of the pat
ients in the digoxin group had undergone valve replacement, as compare
d with only 15+/-3 percent of those in the nifedipine group (P<0.001).
in the digoxin group, valve replacement (in a total of 20 patients) w
as performed because of left ventricular dysfunction (ejection fractio
n <50 percent) in 75 percent, left ventricular dysfunction plus sympto
ms in 10 percent, and symptoms alone in 15 percent. In the nifedipine
group, all six patients who underwent valve replacement did so because
of the development of left ventricular dysfunction. In addition, ail
the patients in both groups who underwent aortic-valve replacement had
an increase of 15 percent or more in the left ventricular end-diastol
ic volume index. After aortic-valve replacement, 12 of the 16 patients
(75 percent) in the digoxin group and all six patients in the nifedip
ine group who had had an abnormal left ventricular ejection fraction b
efore surgery had a normal ejection fraction. Conclusions, Long-term v
asodilator therapy with nifedipine reduces or delays the need for aort
ic-valve replacement in asymptomatic patients with severe aortic regur
gitation and normal left ventricular systolic function.