Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI).

OBJECTIVES: To confirm whether sirolimus-eluting stents (SES) safely reduce the incidence of restenosis in patients with ST-segment elevation acute myocardial infarction compared with bare-metal stents (BMS). BACKGROUND: In the setting of primary angioplasty, stent restenosis occurs in up to 27% of patients. The introduction of drug-eluting stents has drastically reduced the incidence of restenosis in clinically stable patients. METHODS: We conducted a randomized trial of 320 patients with acute ST-segment elevation myocardial infarction assigned to receive SES or BMS. The primary end point was binary restenosis at 1-year angiographic follow-up. RESULTS: At 1 year, the incidence of binary restenosis was lower in the SES group than in the BMS group (9.3% vs. 21.3%, respectively; p = 0.032), as were the rates of target lesion revascularization (4.3% vs. 11.2%; p = 0.02), target vessel revascularization (5% vs. 13.1; p = 0.015), major adverse cardiac events (6.8% vs. 16.8%; p = 0.005), and target vessel failure (8.7% vs. 18.7%; p = 0.007). The incidence of angiographically documented stent thrombosis was 1.2% (n = 2) in the SES group and 0.6% (n = 1) in the BMS group. CONCLUSIONS: In patients with acute myocardial infarction, SES are superior to BMS, reducing the incidence of binary restenosis by 56%, target lesion revascularization by 61%, target vessel revascularization by 62%, adverse cardiac events by 59%, and target vessel failure by 53% at 1 year. (Sirolimus Eluting Stenting in Acute Myocardial Infarction; http://www.clinicaltrials.gov/ct/show/NCT00288210; NCT00288210).

Two-year outcome of a prospective, controlled study of a disease management programme for elderly patients with heart failure.

OBJECTIVE: Elderly heart failure patients are at high risk of events. Available studies and systematic reviews suggest that elderly patients benefit from disease management programmes (DMPs). However, important questions remain open, including the optimal follow-up intensity and duration and whether such interventions are cost-effective during long-term follow-up and in different healthcare systems. The aim of this study was to determine the long-term efficacy of a hybrid DMP in consecutive older outpatients. METHODS: Intervention consisted in combined hospital-based (cardiologists and nurse-coordinators from two heart failure clinics) and home-based (patient's general practitioner visits) care. The components of the DMP were the following: discharge planning, education, therapy optimisation, improved communication, early attention to signs and symptoms. Intensive follow-up was based on scheduled hospital visits (starting within 14 days of discharge), nurse's phone call and home general practitioner visits. RESULTS: A group of 173 patients aged > or =70 years (mean age 77 +/- 6 years, 48% women) was randomly assigned to DMP (n = 86) or usual care (n = 87). At 2-year follow-up, a 36% reduction in all-cause death and heart failure hospital admissions was observed in DMP vs. usual care. All-cause and heart failure admissions as well as the length of hospital stay were also reduced. DMP patients reported, compared to baseline, significant improvements in functional status, quality of life and beta-blocker prescription rate. The intervention was cost-effective with a mean saving of euro 982.04 per patient enrolled. CONCLUSIONS: A hybrid DMP for elderly heart failure patients improves outcomes and is cost-effective over a long-term follow-up.

[Quality of care and management programs for the elderly with heart failure]. / Qualità delle cure e modelli di assistenza per i pazienti anziani con scompenso cardiaco.

The majority of patients with heart failure are elderly. In order to point out the clinical characteristics and the quality of care of elderly heart failure patients we evaluated available data from national databases and observational studies. Elderly patients have more severe clinical manifestations, multiple etiologies and comorbid diseases, frequent hospital admissions, and a worse prognosis. As many as 30-50% of elderly patients with heart failure may have normal systolic function. In the elderly, evidence-based treatments are relatively underused with often inappropriately low doses. However, this "underuse" largely depends on the higher "frailty" of these patients (i.e. multiple coexisting diseases, disability, socio-environmental factors) and the lack of definite evidence on efficacy and safety of treatments in the very elderly. Several studies have documented the efficacy of specialized multidisciplinary heart failure disease management programs in terms of reducing hospital utilization, improving quality of life, functional capacity, patient satisfaction, compliance with diet and medications, and decreasing cost of care. Thus, there are opportunities to improve quality in many aspects of care, such as instrumental and multidimensional assessment and out-of-hospital management. Targeted clinical trials and rigorous observational studies with the aim at favoring the implementation of specific guidelines into clinical practice and continuity of care in the elderly are needed.