Long-Term Results of the Spanish Trial on Treatment and Survival of Patients with Predominantly Mild Heart Failure

Abstract

A randomized open-label clinical trial was conducted to determine whether mortality, readmission, or quality of life differed between heart failure patients managed with captopril plus diuretics and those with digoxin plus diuretics. A total of 345 heart failure patients in New York Heart Association functional classes 2 and 3 without atrial fibrillation, dyspnea of bronchopulmonary origin, or hypertension not controlled with diuretics was randomized for digoxin (n = 175) or captopril (n = 170) treatment and followed up for a median of 4.5 years. Socioeconomic, demographic, electrocardiographic, echocardiographic, spirometric, and chest radiograph data were obtained at the initial examination. In a random sample of half the patients, ergometric, echocardiographic, and Holter records were obtained at entry and at 3 and 18 months. Patients were followed up for > or = 3 years. The end points were mortality, hospitalization for cardiac events, deterioration in quality of life, worsening of functional class, and need for digoxin or captopril in the captopril and digoxin groups, respectively. The trial had to be terminated prematurely owing to the difficulty in finding candidates free of angiotensin-converting enzyme (ACE)-inhibitor treatment. Baseline patient characteristics were similar in both groups. From the clinical point of view, only the 48-month mortality was relevantly lower (20.9 vs. 31.9%, respectively) among patients treated with captopril than that in those receiving digoxin (log rank test, p = 0.07). No statistically or clinically relevant differences were found in other end points or adverse effects. The results suggest but do not confirm the hypothesis that captopril treatment in mild to moderate heart failure might provide better long-term survival than digoxin.

Effect of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers on cardiovascular events in patients with heart failure: a meta-analysis of randomized controlled trials

“…A total of 47,662 subjects were included with a mean/median follow-up ranged from 12 weeks to 4.5 years. Of all 38 studies, six ( n = 8404) trials compared ARBs with placebo [ 13 , 43 – 47 ], while 32 trials ( n = 39,254) compared ACEIs with various control therapies (13 arms ( n = 10,134) compared ACEIs [ 2 – 6 , 23 – 30 ] with placebo treatment; 10 arms ( n = 8714) in which the comparator was active treatment [ 7 , 8 , 31 – 38 ]; and 9 arms ( n = 20,406) compared ACEIs with ARBs [ 9 – 12 , 14 , 39 – 42 ]). Two independent investigators (Y. X. and D.…”

The Role of Angiotensin Receptor Blockers and/or Angiotensin Converting Enzyme Inhibitors in the Prevention of Atrial Fibrillation in Patients with Cardiovascular Diseases:

“…Eighteen studies that remained candidates for inclusion after the first examination were extensively analyzed. Of these studies, 1 was excluded because the follow‐up period was less than 12 weeks, 12 5 due to the absence of the enough data on atrial fibrillation, 13‐18 1 because it was a report of total data subsequently reported, 19 2 because they were subanalysis of studies included in the present analysis, 20,21 1 due to the lack of a control group, 22 and 1 because the primary outcome was hospitalization for atrial fibrillation and not the development of new‐onset or recurrence of atrial fibrillation (Table I) 23 . There were then seven trials used in this meta‐analysis.…”

The Old but Reliable Digitalis: Persistent Concerns and Expanded Indications

“…However, at baseline, patients unable to withdraw from digitalis were excluded from the study 52 . A two‐year mortality study also showed a 20.9% versus 31.9% (log rank test p=0.07) for captopril and digoxin respectively, with no other statistically significant differences in clinical and adverse events 53 . Thus, digitalis in CHF management is on a par with ACE inhibitors.…”

“…52 A two-year.mortality study also showed a 20.9% versus 31.9% (log rank test p=0.07) for captopril and digoxin respectively, with no other statistically significant differences in clinical and adverse events. 53 Thus, digitalis in CHF management is on a par with ACE inhibitors. Other inotropic agents such as dobutamine, beta-agonists, milrinone and enoximone have shown excess mortality.…”