Effects of an intensive long-term prevention programme after myocardial infarction - a randomized trial.

BACKGROUND: Long-term risk factor control after myocardial infarction (MI) is currently inadequate and there is an unmet need for effective secondary prevention programmes. DESIGN AND METHODS: It was the aim of the study to compare a 12-month intensive prevention programme (IPP), coordinated by prevention assistants and including education sessions, telephone visits and telemetric risk factor control, with usual care after MI. Three hundred and ten patients were randomized to IPP vs. usual care one month after hospital discharge for MI in two German heart centres. Primary study endpoint was the IPP Prevention Score (0-15 points) quantifying global risk factor control. RESULTS: Global risk factor control was strongly improved directly after MI before the beginning of the randomized study (30% increase IPP Prevention Score). During the 12-month course of the randomized trial the IPP Prevention Score was improved by a further 14.3% in the IPP group ( p < 0.001), while it decreased by 11.8% in the usual care group ( p < 0.001). IPP significantly reduced smoking, low-density lipoprotein cholesterol, systolic blood pressure and physical inactivity compared with usual care ( p < 0.05). Step counters with online documentation were used by the majority of patients (80%). Quality of life was significantly improved by IPP ( p < 0.05). The composite endpoint of adverse clinical events was slightly lower in the IPP group during 12 months (13.8% vs. 18.9%, p = 0.25). CONCLUSIONS: A novel intensive prevention programme after MI, coordinated by prevention assistants and using personal teachings and telemetric strategies for 12 months, was significantly superior to usual care in providing sustainable risk factor control and better quality of life.

Long-term effects of iron deficiency in patients with heart failure with or without anemia: the RAID-HF follow-up study.

INTRODUCTION: Iron deficiency (ID) has been recognized as a relevant comorbidity in heart failure with reduced ejection fraction (HFrEF); however, study data have shown that diagnostic and therapeutic efforts on ID are primarily performed in patients with anemia. METHODS: The RAID-HF registry investigated consecutive patients with ID and HFrEF in 11 heart centers in Germany and Switzerland. The present analysis focuses on 1-year follow-up data in patients with versus without anemia. RESULTS: In 505 patients with HFrEF and ID and 418 patients with HFrEF without ID 1-year follow-up was performed. Patients with ID had a higher long-term mortality compared to those without ID (19.5% vs. 13.7%, p = 0.02) and reported a lower quality of life. Only a minority of patients with ID (9.3%) received iron supplementation during long-term course, just 4.7% intravenously. Anemia was associated with an elevated mortality whereas ID versus no ID did not predict mortality in anemic patients (log-rank p = 0.78). However, in patients without anemia ID versus no ID predicted mortality (log-rank p = 0.002). In the adjusted analysis a significant interaction remained, with ID being a significant predictor of 1-year mortality in patients without anemia (HR 2.15, 95% CI 1.12-3.78), but not in anemic patients (HR 0.99, 95% CI 0.65-1.49). CONCLUSIONS: RAID-HF demonstrates the impact of ID on long-term mortality and quality of life in patients with HFrEF and reveals an underuse of iron supplementation in current clinical practice. Particularly in patients without anemia the diagnosis of ID is of clinical relevance to identify patients at higher mortality risk.

Impact of right heart function on outcome in patients with functional mitral regurgitation and chronic heart failure undergoing percutaneous edge-to-edge-repair.

AIMS: To evaluate the impact of right ventricular dysfunction (RVD) on outcome after transcatheter mitral valve repair (TMVR) in patients with chronic heart failure (CHF) and severe functional mitral regurgitation (FMR). METHODS AND RESULTS: One hundred thirty patients (median age 72.7 ± 10.7 years; 63.8% male) at high operative risk (LogEuroSCORE 23.8 ± 13.9%) with FMR and CHF (left ventricular ejection fraction 32 ± 7%) were enrolled and separated into two groups according to the RVD. RVD was assessed by the tricuspid annular plane systolic excursion (TAPSE) method (A: TAPSE ≤ 16 mm, n = 58; B: TAPSE > 16 mm, n = 72). The rate of successful reduction of mitral regurgitation (MR ≤2+) by TMVR was similar in both groups (94.6% vs 91.2%; P: n.s.) with low in-hospital major adverse event rates. During a median follow-up period of 10.5 ± 4 months, the Kaplan-Meier analysis revealed a significantly higher all-cause mortality in group A (43.1% vs 23.6%; log-rank P = 0.039) and a significantly higher rate of hospital readmission due to congestive heart failure (56.9% vs 26.4%; log-rank P < 0.001). At long-term follow-up, 25% of patients in group A remained in NYHA functional class IV (none in group B). Preexisting RVD as assessed by TAPSE and Doppler tissue imaging (DTI-S') was an independent predictor of all-cause mortality after TMVR (hazard ratio 2.84; 95% confidence interval 1.15-7.65; P = 0.039; hazard ratio 4.70; 95% confidence interval 1.14-20.21; P = 0.044, respectively). CONCLUSIONS: Patients with CHF and RVD were with regard to functional capacity less often responder and showed an unfavorable long-term outcome. Thus, patients with CHF and RVD seem to benefit less frequently from TMVR.

Management and predictors of outcome in unselected patients with cardiogenic shock complicating acute ST-segment elevation myocardial infarction: results from the Bremen STEMI Registry.

INTRODUCTION: Patients with ST-segment elevation myocardial infarction (STEMI) and consecutive cardiogenic shock (CS) represent a challenge in clinical practice. Only few 'real-world' data on therapeutic management and outcome exist. METHODS: The present analysis focuses on changes of clinical management of STEMI-patients with CS and analyzes predictors of outcome using the Bremen-STEMI registry. RESULTS: Out of 7865 patients with STEMI, 981 patients (13%) presented with CS. Most CS patients (88%) underwent an early percutaneous intervention (PCI). Intraaortic balloon pumps (IABP) were less implanted since 2013 (p < 0.001), the rate of drug-eluting stents and periprocedural prasugrel or ticagrelor therapy increased over the years. Overall in-hospital mortality of patients with CS was 37%, 1 year mortality was 50%. A significantly reduced 1-year mortality (2006-2009: 55%, 2010-2013: 50%; 2014-2015: 43%, p = 0.027) was observed. In a multivariate analysis significant predictors of an increased 1-year mortality were acute renal failure (OR 3.6; 95% CI 1.9-7.0), atrial fibrillation (OR 2.8; 95% CI 1.3-6.0), three-vessel disease (OR 2.5; 95% CI 1.3-4.7), age ≥ 75 years (OR 2.4, 95% CI 1.3-4.4) and anemia (OR 1.9; 95% CI 1.1-3.3). A successful performed PCI (OR 0.5, 95% CI 0.2-0.9) was associated with a significantly reduced 1-year mortality. CONCLUSION: management of patients with CS changed with a steep decrease of IABP implantations. Mortality of patients with CS decreased over the last 10 years. Especially, performance of successful PCI was associated with a reduction of mortality, indicating the crucial role of early revascularization to improve prognosis in this high-risk cohort of STEMI-patients.

Bivalirudin versus heparin and provisional GP IIb/IIIa inhibitors in patients treated for ST-segment elevation myocardial infarctions: Comparison of outcomes in a "real-world" setting.

INTRODUCTION: The beneficial effects of bivalirudin during primary PCIs are controversially discussed, data on unselected patients are rare. It was the aim of the study to compare bivalirudin versus heparin and provisional glycoprotein IIb/IIIa inhibitors (GPIs) in a "real-world" study. METHODS: From 05/2013 until 11/2014, the STEMI-patients in the Bremen STEMI registry were treated with periinterventional bivalirudin; before and after this period the standard anticoagulative treatment was heparin and provisional GPIs. RESULTS: In 714 patients bivalirudin was used for PCI, this cohort was compared to 683 patients with heparin and provisional GPIs. In patients with bivalirudin a significantly lower rate of hospital bleedings was observed compared to patients with heparin (4.6% vs 8.1%, P < 0.01, multivariate HR 0.57, 95%CI 0.35-0.93), in an exclusive analysis of severe bleedings a trend toward less bleedings was found in patients with bivalirudin (2.0% vs 3.5%, P = 0.07, multivariate HR 0.66, 95%CI 0.30-1.42). The rate of stent thromboses reinfarctions and mortality was not different between the bivalirudin and the heparin group. During 1-year follow-up bivalirudin was associated with a lower rate of bleedings and no significant differences in stent thromboses, reinfarctions, and mortality. Bivalirudin was not associated with an excess of bleedings or stent thromboses in subgroups that are regularly underrepresented in randomized trials (older patients, women, cardiogenic shock). CONCLUSIONS: In this "real-world" cohort of patients with STEMI bivalirudin compared to heparin and GPIs was associated with less bleedings and no significant differences in stent thromboses, reinfarctions, and mortality during hospital and long-term course.

The US7 score is sensitive to change in a large cohort of patients with rheumatoid arthritis over 12 months of therapy.

PURPOSE: To determine the sensitivity to change of the US7 score among RA patients under various therapies and to analyze the effect of each therapeutic option over 1 year. To estimate predictors for development of destructive bone changes. METHODS: Musculoskeletal ultrasound (US7 score), DAS28, CRP and ESR were performed in 432 RA patients at baseline and after 3, 6 and 12 months. The cohort was divided into four sub-groups: first-line DMARDs (Group 1; 27.3%), therapy switch: DMARDs to second DMARDs (Group 2; 25.0%), first-line biologic after DMARDs therapy (Group 3; 35.4%) and therapy change from biologic to second biologic (Group 4; 12.3%). RESULTS: The US7 synovitis and tenosynovitis sum scores in grey-scale (GSUS) and power Doppler ultrasound (PDUS) as well as ESR, CRP decreased significantly (p<0.05) after 12 months in group 1 to 3. Group 1+2 also illustrated a significant change of DAS28 after 1 year (p<0.001). Only in Group 4, the US7 erosion sum score decreased significantly from 4.3 to 3.6 (p=0.008) after 1 year. Predictors capable of forecasting US erosions after one year were: higher score of US7 synovitis (p<0.001), of US7 erosions in GSUS (p<0.001), as well as of DAS28 (p<0.001) at baseline. CONCLUSIONS: The comparable developments of the US7 score with clinical and laboratory data illustrates its potential to reflect therapeutic response. Therefore, the novel US7 score is sensitive to change. Patients who switched from one biologic to another exhibited a significant decline in erosions after 12 months, while the erosions scores in the other groups were stable.