Hotline sessions of the 27th European congress of cardiology.

This year’s Congress of the European Society of Cardiology was held in Stockholm, Sweden from the 3rd to the 7th of September 2005. Summaries of the preliminary results of 12 of the 14 studies presented at the three Hotline Sessions are reported here. The CIBIS-III and BASKET trials have been published in Circulation 2005;112:2426–2435 and Lancet 2005;366:921–929, respectively. Data reported in this summary have been collected from press releases and presentations of the speakers. During the first Hotline Session, three trials on heart failure were presented. Prof. Marco Metra from Brescia, Italy presented the ESSENTIAL study. In this randomized placebo-controlled trial, the effect of long-term treatment with low-dose oral enoximone (25–50 mg three times daily), a phosphodiesterase III inhibitor, in patients with advanced heart failure was studied. It was hypothesized that enoximone could reduce the co-primary endpoints time to cardiovascular (CV) hospitalization or all-cause mortality and would improve submaximal exercise tolerance and symptoms. In total, 1854 patients with ‘ischaemic and non-ischaemic’ cardiomyopathy (CMP), heart failure NYHA classes III and IV, and a left ventricular ejection fraction (LVEF) 30% were randomized to enoximone (n 1⁄4 926) or placebo (n 1⁄4 928). Results were presented for identical studies only differing by geographical location: America and Europe. With respect to baseline characteristics, mean age was 62 years, ischaemic CMP was present in 56%, NYHA class III in 91%, the mean LVEF was 23.6%, and almost 90% of the patients used beta-blockers and ACE-inhibitors. American patients had significantly lower mean LVEF, less exercise tolerance, and a longer duration of heart failure. At the end of the study, non-fatal withdrawal from study drug was 21%. During 16.4+ 0.2 months follow-up enoximone and placebo did not differ with respect to all-cause mortality and CV hospitalization (49.5 vs. 50.1%, HR 0.98; P 1⁄4 0.71) or all-cause mortality alone (21.7 vs. 22.6%, HR 0.97; P 1⁄4 0.73). The 6 min walking test significantly improved in American patients treated with enoximone with 10 m when compared with placebo, but not in European patients (1.5 m). In the enoximone and placebo groups, a similar improvement in symptoms was found. The adverse events, diarrhoea and palpitations, were more often reported in the enoximone group. With respect to safety, enoximone had no pro-arrhythmic effect as evidenced by equal rates in sudden death or atrial fibrillation. Thus, in patients with advanced heart failure already optimally treated with beta-blockers and ACE-inhibitors, treatment with oral enoximone was neither beneficial nor harmful. Prof. Roberto Ferrari from Ferrara, Italy presented PRE-AMI, a multi-centre, randomized, double-blind, placebo-controlled trial investigating the role of perindopril in elderly patients with acute myocardial infarction (AMI) and preserved left ventricular (LV) function. High-dose perindopril (8 mg once daily) started within 20 days after AMI and continued for 12 months was compared with placebo. Patients older than 65 years, LVEF.40%, and a good apical view on echocardiography were included. The primary composite endpoint was allcause mortality, hospitalization for heart failure, and LV remodelling defined as 8% increase in LV end-diastolic volume (LVEDV) between baseline, 6, and 12 months follow-up echocardiography. In total, 1252 patients were randomized: 631 to perindopril and 621 to placebo. Remodelling was assessed in 455 and 441 patients, respectively. Baseline characteristics were mean age 72 years, mean ejection fraction 59%, NYHA class I in 80%, prior myocardial infarction in 10%, and diabetes in 23%. After enrolment, 70% of patients were treated with beta-blockers and almost 80% used the study drug during complete follow-up. The primary endpoint was significantly reduced with 38% in favour of perindopril-treated patients (P, 0.001). This finding was mainly driven by the reduction in incidence of LV remodelling: 27.7 vs. 51.2% (P, 0.001). The secondary endpoints CV death, myocardial infarction, unstable angina, and revascularization were not reduced by perindopril. Importantly, adverse events were not noted in patients on perindopril. From this pathophysiologically relevant study, we can conclude that even in the elderly with relatively small infarctions and preserved LV function, perindopril can reduce LV remodelling and is tolerated well. Possibly because of the low-risk population studied, the delayed initiation of ACE-inhibitors after AMI and the relatively short duration of follow-up, reduction in LV remodelling was not translated in improved clinical outcome.