Benefits of tafamidis in patients with advanced transthyretin amyloid cardiomyopathy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Rapezzi ◽  
A.V Kristen ◽  
B Gundapaneni ◽  
M.B Sultan ◽  
M Hanna
Keyword(s):  
Disease Severity ◽  
Nyha Class ◽  
Funding Source ◽  
Class Iii ◽  
Private Company ◽  
Risk Of Death ◽  
6Mwt Distance ◽  
All Cause Mortality ◽  
Amyloid Cardiomyopathy

Abstract Background In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis was shown to be an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Further assessment of the efficacy of tafamidis in patients with more advanced ATTR-CM would aid treatment decisions. Purpose To characterize the benefits of tafamidis in patients with advanced ATTR-CM. Methods In ATTR-ACT, ATTR-CM patients were randomized to tafamidis (n=264) or placebo (n=177) for 30 months. Efficacy outcomes included all-cause mortality and frequency of cardiovascular (CV)-related hospitalisations. Key secondary endpoints were change from baseline to Month 30 in 6MWT distance and KCCQ-OS score. Efficacy assessments in NYHA Class III patients at baseline (n=141) were a pre-specified analysis. In a post-hoc analysis, mortality and CV-related hospitalizations were assessed in all patients grouped into quartiles of increasing disease severity based on 6MWT distance at baseline. Longer-term all-cause mortality (as of 1 Aug 2019) was assessed in NYHA Class III patients utilizing data from ATTR-ACT patients who enrolled in a long-term, extension study (LTE) and continued treatment with higher dose tafamidis (n=55; median treatment duration 51.6 months); or, if previously treated with placebo, started tafamidis treatment (placebo/tafamidis; n=63 [50.1 months]). Results In advanced ATTR-CM patients (NYHA Class III), tafamidis reduced the risk of death (HR [95% CI] 0.837, [0.541, 1.295], P=0.4253), and the decline in 6MWT distance (LS mean [SE], 31.6 (22.1) m; P=0.1526) and KCCQ-OS score (LS mean [SE], 13.1 (5.0); P=0.0090), vs placebo. Paradoxically, there was a higher frequency of CV-related hospitalizations with tafamidis (RR [95% CI] vs placebo, 1.411 [1.048, 1.900]). In all patients by 6MWT quartile, CV-related hospitalizations/year with tafamidis and placebo increased with disease severity, with the exception that placebo-treated patients in the highest severity quartile had fewer CV-related hospitalisations (0.73) than those in the third quartile (0.92). Mortality with tafamidis and placebo increased, and was greater with placebo, in every quartile (Figure). Survival (NYHA Class III patients in ATTR-ACT and LTE) was improved with high dose tafamidis with longer term follow-up (HR vs placebo/tafamidis [95% CI], 0.6569 [0.4175, 1.0336]; P=0.0692). Conclusions These analyses, including longer-term follow-up, demonstrate that patients with advanced ATTR-CM benefit from tafamidis. The decrease in CV-related hospitalisations in more severe patients treated with placebo suggests that the comparatively greater hospitalisation frequency in NYHA Class III patients treated with tafamidis is a consequence of their lower mortality rate. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer

scholarly journals Favorable course of tricuspid regurgitation after percutaneous mitral valve repair is associated with improved survival and clinical outcome

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Meijerink ◽  
J Baan ◽  
B.J Bouma
Keyword(s):  
Mitral Valve ◽  
Clinical Outcome ◽  
Mitral Valve Repair ◽  
Tricuspid Regurgitation ◽  
Nyha Class ◽  
Funding Source ◽  
Valve Repair ◽  
Percutaneous Mitral Valve Repair ◽  
All Cause Mortality

Abstract Background Tricuspid Regurgitation (TR) is often present in patients with mitral regurgitation (MR) and is associated with increased mortality and morbidity after percutaneous mitral valve repair (PMVR) using the MitraClip (Abbott Vascular). It is unclear to what extent TR is reduced after PMVR and whether the reduction of TR is related to survival and functional outcome. Purpose The aim of this study was to determine (1) the TR course after PMVR and (2) if this was related to survival and clinical outcome. Methods Patients who underwent PMVR and had complete echocardiographic data at baseline and follow-up were included. TR severity was graded as none, mild, moderate or severe (according to current guidelines) and was determined before treatment and at 6-months of follow up. Favorable TR course was defined as improvement of ≥1 grade or ≤ mild TR at 6-months. Clinical endpoints were all-cause mortality during 1-year of follow-up and improvement in New York Heart Association (NYHA) functional class after 6 months. Results A total of 67 patients were included (mean age 76 years, 57% male, 81% NYHA class ≥3 and 69% baseline TR ≥ moderate). Favorable TR course was achieved in 31 patients (46%) (figure 1A). All-cause mortality at 1 year was 7.5%, and was lower in the favorable TR course group (0% vs. 13.9%, p=0.057) (figure 1B). Improvement in NYHA class at 6-months was seen in 45% of patients without vs. 81% of patients with favorable TR course (p=0.01) (figure 1C). Conclusion A favorable TR course is achieved in 46% of PMVR patients and is associated with improved survival and improvement of NYHA class. The relatively high rate of an unfavorable TR course at 6-months, indicates that interventional treatment of the tricuspid valve might benefit these patients. TR course (A) and NYHA improvement (B) Funding Acknowledgement Type of funding source: Other. Main funding source(s): Abbott

Relationship between frailty and all-cause mortality in patients with atrial fibrillation: a report from the ESC-EHRA EURObservational research programme AF general long-term registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
M Vitolo ◽  
S Harrison ◽  
G.A Dan ◽  
A.P Maggioni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Frailty Index ◽  
Primary Study ◽  
Funding Source ◽  
Private Company ◽  
Kaplan Meier ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Introduction Frailty is a major health determinant for cardiovascular disease. Thus far, data on frailty in patients with atrial fibrillation (AF) are limited. Aims To evaluate frailty in a large contemporary cohort of European AF patients, the relationship with oral anticoagulant (OAC) prescription and with risk of all-cause death. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. A 38-items frailty index (FI) was derived from baseline characteristics according to the accumulation of deficits model proposed by Rockwood and Mitnitsky. All-cause mortality was the primary study outcome. Results Out of the 11096 AF enrolled patients, data for evaluating frailty were available for 6557 (59.1%) patients who have been included in this analysis (mean [SD] age 68.9 [11.5], 37.7% females). Baseline median [IQR] CHA2DS2-VASc and HAS-BLED were 3 [2–4] and 1 [1–2], respectively. At baseline, median [IQR] FI was 0.16 (0.12–0.23), with 1276 (19.5%) patients considered “not-frail” (FI<0.10), 4033 (61.5%) considered “pre-frail” (FI 0.10–0.25) and 1248 (19.0%) considered “frail” (FI≥0.25). Age, female prevalence, CHA2DS2-VASc and HAS-BLED progressively increased across the FI classes (all p<0.001). Use of OAC progressively increased among FI classes; after adjustments FI was not associated with OAC prescription (odds ratio [OR]: 1.09, 95% confidence interval [CI]: 0.98–1.19 for each 0.10 FI increase). Conversely, FI was directly associated with vitamin K antagonist (VKA) use (OR: 1.26, 95% CI: 1.18–1.34 for each 0.10 FI increase) and inversely associated with non-VKA OACs (NOACs) use (OR: 0.82, 95% CI: 0.77–0.88). FI was significantly correlated with CHA2DS2-VASc (Rho= 0.516, p<0.001). Over a median [IQR] follow-up of 731 [704–749] days, there were 569 (8.7%) all-cause death events. Kaplan-Meier curves [Figure] showed an increasing cumulative risk for all-cause death according to FI categories. A Cox multivariable analysis, adjusted for age, sex, type of AF and use of OAC, found that increasing FI as a continuous variable was associated with an increased risk of all-cause death (hazard ratio [HR]: 1.56, 95% CI: 1.40–1.73 for each 0.10 FI increase). An association with all-cause death risk was found across the FI categories (HR: 1.71, 95% CI: 1.23–2.38 and HR: 2.88, 95% CI: 2.02–4.12, respectively for pre-frail and frail patients compared to non-frail ones). FI was also predictive of all-cause death (c-index: 0.660, 95% CI: 0.637–0.682; p<0.001). Conclusions In a European contemporary cohort of AF patients the burden of frailty is significant, with almost 1 out of 5 patients found to be “frail”. Frailty influenced significantly the choice of OAC therapy and was associated with (and predictive of) all-cause death at follow-up. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP programme, several companies have supported it with unrestricted grants.

2179Clinical significance of device-derived activity in ICD and CRT-D patients - Data from MADIT-RIT

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Kutyifa ◽  
P Jones ◽  
I Goldenberg ◽  
M Brown ◽  
W Zareba ◽  
...  
Keyword(s):  
Daily Activity ◽  
Proportional Hazards ◽  
Nyha Class ◽  
Cox Proportional Hazards ◽  
Activity Level ◽  
Inappropriate Therapy ◽  
Class Iii ◽  
Risk Of Death ◽  
Risk Of Mortality ◽  
All Cause Mortality

Abstract Background The Multicenter Automatic Defibrillator Implantation Trial – Reduce Inappropriate Therapy (MADIT-RIT) enrolled 1500 patients and showed that novel ICD programming reduced inappropriate therapy and improved survival. However, the role of device-derived patient activity to predict mortality is not known. Methods In 1500 patients enrolled in MADIT-RIT, device-derived patient activity was captured daily. Device-derived activity was averaged for the first 30 days following randomization, and utilized in this study to predict mortality post-30 days. Kaplan-Meier survival analysis and multivariate Cox proportional hazards regression models were used to evaluate all-cause mortality by 30-day device derived patient activity quintiles, and as a 3-level function of 30-day device derived patient activity (Q1, Q2–3, Q4–5). Results There were a total of 1463 patients with data available (98%), 66 of them died during the follow-up post-30 days. Patients in the lowest quintile (Q1: 4%∼1 hour daily activity) of device-derived activity were older, they were more often female, and they more often had diabetes and NYHA class III HF symptoms. Patients in the lowest quintile of 30-day device derived median activity (1 hour daily activity) had the highest risk of mortality, 15% in 2 years as compared to Q2–3 (1–2 hours daily activity, 8–7% 2-year mortality), and Q4–5 (>2 hours daily activity, 2–3% 2-year mortality) (Figure, p<0.001 for the overall duration). Each quintile decrease in device-derived 30-day median patient activity was associated with a significant, 41% increase in mortality (HR=1.41, 95% CI: 1.15–1.71, p=0.001). Patients with the lowest level of 30-day median patient activity (Q1) had 4.13-times higher risk of mortality as compared to the highest level of activity patients, Q4–5 (HR=4.13, 95% CI: 1.89–9.03, p<0.001). Patients with intermediate levels of activity (Q2–3) still had a 2.8-fold increase in death as compared to the highest activity level cohort of patients (HR=2.79, 95% CI: 1.31–5.91, p=0.008). Figure 1 Conclusions Device-derived 30-day median patient activity predicted subsequent all-cause mortality in ICD and CRT-D patients enrolled in MADIT-RIT. Patients with low and moderate levels of 30-day device-derived median patient activity (less than 2 hours daily activity) were at a significantly higher risk of death, and these cohorts warrant further investigation and management to improve outcomes. Acknowledgement/Funding MADIT-RIT was funded by an unrestricted research grant from Boston Scientific to the University of Rochester.

scholarly journals Impact of effective regurgitant orifice area on outcome of secondary mitral regurgitation transcatheter repair

2021 ◽  
Author(s):  
Nicole Karam ◽  
◽  
Mathias Orban ◽  
Daniel Kalbacher ◽  
Christian Butter ◽  
...  
Keyword(s):  
Mitral Regurgitation ◽  
Nyha Class ◽  
Class Iii ◽  
Proximal Isovelocity Surface Area ◽  
All Cause Mortality ◽  
Patient Groups ◽  
Predicting Outcome ◽  
Secondary Mitral Regurgitation ◽  
Regurgitant Orifice Area

Abstract Objectives To assess the value of effective regurgitant orifice (ERO) in predicting outcome after edge-to-edge transcatheter mitral valve repair (TMVR) for secondary mitral regurgitation (SMR) and identify the optimal cut-off for patients’ selection. Methods Using the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry, that included patients undergoing edge-to-edge TMVR for SMR between November 2008 and January 2019 in 8 experienced European centres, we assessed the optimal ERO threshold associated with mortality in SMR patients undergoing TMVR, and compared characteristics and outcomes of patients according to baseline ERO. Results Among 1062 patients with severe SMR and ERO quantification by proximal isovelocity surface area method in the registry, ERO was < 0.3 cm2 in 575 patients (54.1%), who were more symptomatic at baseline (NYHA class ≥ III: 91.4% vs. 86.9%, for ERO < vs. ≥ 0.3 cm2; P = 0.004). There was no difference in all-cause mortality at 2-year follow-up according to baseline ERO (28.3% vs. 30.0% for ERO < vs. ≥ 0.3 cm2, P = 0.585). Both patient groups demonstrated significant improvement of at least one NYHA class (61.7% and 73.8%, P = 0.002), resulting in a prevalence of NYHA class ≤ II at 1-year follow-up of 60.0% and 67.4% for ERO < vs. ≥ 0.3 cm2, respectively (P = 0.05). Conclusion All-cause mortality at 2 years after TMVR does not differ if baseline ERO is < or ≥ 0.3 cm2, and both groups exhibit relevant clinical improvements. Accordingly, TMVR should not be withheld from patients with ERO < 0.3 cm2 who remain symptomatic despite optimal medical treatment, if TMVR appropriateness was determined by experienced teams in dedicated valve centres.

scholarly journals Prognostic value of global longitudinal strain versus mitral annular plane systolic excursion in patients with ischemic heart failure

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Liu ◽  
C Wagner ◽  
K Hu ◽  
B Lengenfelder ◽  
G Ertl ◽  
...  
Keyword(s):  
Heart Failure ◽  
Longitudinal Strain ◽  
Nyha Class ◽  
Global Longitudinal Strain ◽  
Ischemic Heart ◽  
Ischemic Heart Failure ◽  
Class Iii ◽  
Heart Failure Patients ◽  
All Cause Mortality

Abstract Background Mitral annular plane systolic excursion (MAPSE) derived from M-mode echocardiography is a classical risk factor of clinical outcome in heart failure patients. Two-dimensional-echocardiography (2DE) derived global longitudinal strain (GLS) is also related to outcome in patients with heart failure. This study aimed to compare the prognostic performance between GLS and MAPSE in ischemic heart failure patients with reduced ejection fraction. We sought to test the hypothesis that GLS might be superior to MAPSE as a risk stratification marker in these patients. Methods In total, 1277 ischemic heart failure patients with reduced left ventricular ejection fraction (LVEF&lt;50%), referred to our department between 2009 and 2017, were included in this retrospective study. Offline standard echocardiographic measurements including MAPSE and GLS were performed. Average MAPSE of septal and lateral walls (MAPSE_Avg) was calculated. GLS was derived from the segmental averaging (18-segment) of the three apical views. All patients completed at least one-year clinical follow-up by telephone interview or clinical visit. The primary endpoint was defined as all-cause mortality or heart transplantation (HTx). Results At baseline visit, mean age was 70±11 years and 79.6% were men. NYHA class III-IV were identified in 33.5% of patients. Coronary artery disease was confirmed by coronary angiography. 63.0% patients had a history of myocardial infarction, 32.1% underwent PCI, and 16.8% underwent coronary artery bypass grafting. Over a median follow-up period of 26 (14–39) months, 369 (28.9%) patients died and 5 (0.4%) underwent HTx. Median LVEF was 39% (32–45%), and there were 48.0% patients with LVEF between 40–49%, 32.3% patients with LVEF between 30–49% and 19.7% patients with LVEF &lt;30%. MAPSE_Avg was 8.0 (6.5–10.0) mm and median GLS was −9.9% (−7.7 to −12.3%). Clinical covariates significantly associated with all-cause mortality in this cohort included age (HR=1.048), NYHA class III-IV (HR=1.800), AF (HR=1.567), diabetes (HR=1.262), dyslipidemia (HR=0.657), hyperuricemia (HR=1.861), peripheral vascular disease (HR 1.858), chronic respiratory diseases (HR=1.680), and renal dysfunction (HR=2.705). Multivariable Cox regression analysis showed that reduced MAPSE_Avg (&lt;7mm, HR=1.431, 95% CI 1.146–1.786) and reduced GLS (&lt;8.3%, HR=1.519, 95% CI 1.230–1.875) were independent predictors of all-cause mortality after adjustment of above-mentioned clinical confounders. ROC curves demonstrated that the predictive performance of all-cause mortality among LVEF, MAPSE_Avg, and GLS were similar (AUC=0.608, 0.601, and 0.616, respectively, all P&lt;0.001). Conclusions Both 2DE-guided GLS and MAPSE could provide additional prognostic information in ischemic heart failure patients with reduced LVEF. Prognostic performance of GLS, MAPSE, and LVEF is similar in ischemic heart failure patients with reduced LVEF. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): The German Federal Ministry of Education and Research

Impact of physical activity on all-cause mortality in European patients with atrial fibrillation: a report from the ESC-EHRA EORP AF General Long-Term Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Vitolo ◽  
M Proietti ◽  
S Harrison ◽  
Z Kalarus ◽  
L Tavazzi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Atrial Fibrillation ◽  
Funding Source ◽  
Private Company ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
All Cause Mortality ◽  
The Impact

Abstract Background Physical activity (PA) may have a beneficial contribution for outcomes in patients with atrial fibrillation (AF). Purpose We aimed to evaluate the impact of self-reported PA in a large contemporary cohort of European AF patients on the risk of all-cause mortality. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Self-reported PA was categorized, on the basis of reported time spent exercising, as follows: i) No PA; ii) Occasional PA; iii) Regular PA; iv) Intense PA. The primary outcome was all-cause death. Results Over 11096, a total of 8699 (78.4%) patients (mean age (SD) 69.1 (11.5); 40.7% female) had available data about PA and follow-up observation and were included in the analysis. Of these, 3703 (42.6%) reported no PA, 2829 (32.5%) occasional PA, 1824 (21.0%) regular PA, with only 343 (3.9%) reporting intense PA. With the 4 increasing PA categories, mean age, proportion of female patients, CHA2DS2-VASc and HAS-BLED scores were progressively lower (all p&lt;0.001). Use of vitamin K antagonist (VKA) declined across the classes of PA (53.1% vs. 52.2% vs. 44.5% vs. 33.9%, p&lt;0.001), while use of non-VKA OACs (NOACs) conversely increased. During a mean (SD) 680.6 (171.5) days of follow-up, there were a total of 848 (9.7%) all-cause death events. Based on Kaplan-Meier analysis, there was a progressively lower cumulative risk for all-cause death according to PA categories [Figure]. A multivariable Cox regression analysis, adjusting for CHA2DS2-VASc score, use of OAC at baseline and type of AF, found a lower risk of all-cause death associated with increasing levels of PA (Hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.59–0.81 for occasional PA, HR: 0.45, 95% CI: 0.35–0.58 for regular PA, HR: 0.41, 95% CI: 0.23–0.76 for intense PA, when compared to no PA). In a sensitivity analysis, a regular-intense PA was inversely associated with occurrence of cardiovascular (CV) death, after multivariable adjustments for comorbidities (HR: 0.54, 95% CI: 0.37–0.77). Conclusions In a large contemporary cohort of European AF patients, self-reported PA was found to be inversely associated with all-cause death and CV death. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP, several companies have supported the programme with unrestricted grants

1169Interim analysis of data from a long-term, extension trial of tafamidis meglumine in patients with transthyretin amyloid cardiomyopathy

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Elliott ◽  
B M Drachman ◽  
S S Gottlieb ◽  
J E Hoffman ◽  
S L Hummel ◽  
...  
Keyword(s):  
Amyloid Fibrils ◽  
Nyha Class ◽  
Randomized Study ◽  
Pooled Analysis ◽  
Extension Study ◽  
Class Iii ◽  
Double Blind ◽  
All Cause Mortality ◽  
Amyloid Cardiomyopathy

Abstract Background Transthyretin amyloid cardiomyopathy (ATTR-CM), is an underdiagnosed, fatal disease caused by the deposition of transthyretin amyloid fibrils in the heart leading to heart failure. The Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), an international, multi-center, double-blind, placebo-controlled, randomized study, demonstrated the efficacy and safety of tafamidis treatment for patients with ATTR-CM due to variant (ATTRm) or wild-type (ATTRwt) TTR. Purpose This is a pooled analysis of data from ATTR-ACT and interim data from the ongoing, long-term, extension study to evaluate longer term data on the efficacy of tafamidis in patients with ATTR-CM. Methods Patients who completed ATTR-ACT (which had a duration of 30 months) were eligible to be enrolled in a long-term, extension study in which patients either continued to receive tafamidis meglumine at the same dose (the tafamidis/tafamidis [T/T] group) or, for patients previously treated with placebo, were randomised (in a 1:2 ratio) to tafamidis meglumine 20 mg or 80 mg (the placebo/tafamidis [P/T] group) for up to 60 months. The primary efficacy outcome was all-cause mortality. This analysis combined data from the completed ATTR-ACT with interim data from the extension study (cut-off date: 15 Feb, 2018), and included patients treated with tafamidis meglumine across the two studies with a median follow up of 36 months. Results All-cause mortality was significantly lower in the T/T group (n=264; 88 events, 33.3%) compared with the P/T group (n=177; 88 events, 50.3%); hazard ratio (95% CI), 0.64 (0.47, 0.85); P=0.001. In the subgroup of ATTRwt patients, all-cause mortality was significantly reduced in the T/T group (55/201; 27.4%) compared with the P/T group (60/134; 44.8%); 0.64 (0.44, 0.92); P=0.002. In the 106 (24.0%) ATTRm patients, there was a trend towards a reduction in all-cause mortality in the T/T group (33/63; 52.4%) compared with the P/T group (29/43; 67.4%); 0.66 (0.39, 1.09); P=0.17. In patients who were NYHA Class I or II at baseline, all-cause mortality was significantly reduced in the T/T group (38/186; 20.4%) compared with the P/T group (45/114; 39.5%); 0.49 (0.32, 0.75); P=0.001. In those patients with more severe symptoms at baseline (NYHA Class III), there were fewer deaths in the T/T group (50/78; 64.1%) compared with the P/T group (44/63; 69.8%); 0.80 (0.53, 1.21), but this difference was not statistically significant (P=0.50). Conclusions In ATTR-ACT, tafamidis was shown to significantly improve survival, functional capacity, and quality of life in patients with ATTR-CM. This pooled analysis with data from the ongoing extension study further supports the efficacy of tafamidis in patients over a longer period of time and the importance of early diagnosis and treatment. Acknowledgement/Funding This study was sponsored by Pfizer.

Temporal changes in quality of life amongst European atrial fibrillation patients: relationship to all-cause mortality. A report from the ESC-EHRA EORP-AF General Long-Term Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Vitolo ◽  
M Proietti ◽  
S Harrison ◽  
L Fauchier ◽  
F Marin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Temporal Changes ◽  
Funding Source ◽  
Private Company ◽  
All Cause Mortality ◽  
Over Time

Abstract Background Atrial fibrillation (AF) significantly impacts on patients' quality of life (QoL). An impaired QoL has been associated with worse outcomes even in AF patients, but contemporary data in a large-scale pan-European population are limited. Purpose We aimed to assess temporal changes in AF patients' QoL across 2 years follow-up observation, and the relationship of QoL changes with all-cause death. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. The EQ-5D-5L questionnaire was used to assess QoL. A Health Utility Score (HUS), indicating the overall health state (1 equals perfect health), was derived. Differences throughout the follow-up (Baseline, 1-Y FU, 2-Y FU) observation were assessed. The study outcome was all-cause mortality. Results Out of a total of 11906 patients, 8097 (73.0%) were available for this analysis. Mean (SD) age was 69.1 (11.5) years; 60.8% males; median CHA2DS2-VASc and HASBLED scores were 3 (IQR 2–4) and 1 (1–2), respectively. The mean (SD) HUS at baseline was 0.815 (0.200) and 0.834 (0.196), 0.829 (0.195) at 1-year follow-up and 2-year follow-up, respectively (p&lt;0.0001 for changes over time). Patients with a higher CHA2DS2-VASc score (CHA2DS2-VASc 6–9) reported a significant reduction in the quality of life, compared to the other CHA2DS2-VASc strata, with a mean (SD) HUS decreasing from 0.754 (0.214) at baseline to 0.727 (0.238) at 2-year follow-up (F=6.538, p&lt;0.0001) (Figure). Multivariate analysis demonstrated that age [−0.001 (95% CI [−0.002, −0.121]) and coronary artery disease (CAD) [−0.016 (95% CI [−0.029, −0.004] were independently inversely associated with increasing QoL. Positive changes in HUS over time were inversely associated with an increase in the risk of all-cause death, even after adjusting for chronic kidney disease, liver disease, chronic obstructive pulmonary disease, oral anticoagulants and type of AF (OR:0.24, 95% CI: 0.13–0.45 for increasing HUS difference, as a continuous variable). Conclusions In a contemporary European-wide cohort of AF patients, significant temporal changes in QoL were found. Patients at higher stroke risk according to CHA2DS2-VASc score showed a significant reduction in the QoL. Age and CAD were independently associated with changes in QoL. A greater reduction in HUS (i.e. worsening QoL) over time was associated with a higher risk of all-cause death. Temporal changes in HUS Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP, several companies have supported the programme with unrestricted grants

Treatment with sacubitril/valsartan in European outpatients with chronic heart failure in Europe: results from ARIADNE registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Maggioni ◽  
V Barrios ◽  
A.L Clark ◽  
T Damy ◽  
J Drozdz ◽  
...  
Keyword(s):  
Heart Failure ◽  
Real World ◽  
Nyha Class ◽  
Real Life ◽  
Class Ii ◽  
Funding Source ◽  
Class Iii ◽  
Observational Period ◽  
Private Company ◽  
Β Blocker

Abstract Background Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan (S/V) was introduced as a novel therapeutic option into European guidelines for the management of heart failure (HF). The Assessment of Real lIfe cAre –Describing EuropeaN hEart failure management (ARIADNE) registry provides real world information about its use and efficacy in real life in outpatients with heart failure with reduced ejection fraction (HFrEF) in Europe. Methods ARIADNE was a prospective registry of patients with HFrEF (NYHA II-IV, reduced EF) treated by office-based cardiologists or selected primary care physicians (recognized as HF specialists) in a real world setting. 9069 HFrEF patients were enrolled from 674 investigators in 17 European countries, and followed over 12 months. Out of 8787 patients fulfilling criteria for analysis, 52.5% of the patients received S/V treatment at baseline, whereas 47.5% continued on their previous individualized heart failure medication. Results of S/V patients are reported here. Results The mean age of patients prescribed S/V was 67.3 years, mainly NYHA class II or III (49.7% and 48.2%, respectively), and mean LVEF of 32.7%. Common documented comorbidities were arterial hypertension (63.7%), coronary heart disease (62.4%), dyslipidemia (50.3%), diabetes (32.5%), and chronic kidney disease (24.1%). Of the 4143 patients in the S/V group, 89.9% received S/V at baseline, 74.8% received S/V in combination with a β-blocker; 47.8% with a β-blocker and MRA. Within 6 months of the observational period, 693 (17.4%) of the S/V patients were hospitalized, of which 46.8% and 28.7%, had HF related and non-HF cardiovascular (CV) hospitalizations. Emergency room visits without hospitalization were documented for 3.4% of S/V patients in the same time period; stroke and myocardial infarction occurred in 22 (0.5%) and 24 (0.6%) of the S/V patients, respectively. Cardiac catheterization or coronary angiography procedures were applied to 1.7% and 2.8% of the S/V patients. Total mortality was 4.3% (S/V 3.8%; non-S/V 5.0%), cardiovascular mortality 1.9% (S/V 1.8%; non-S/V 2.2%), during the 12 month observational period. The proportion of S/V patients in NYHA class III or IV decreased in the course of the study from 44.6% to 24.0%. After 12 months of follow up, 46.3% of patients with NYHA class III had a reported improvement to NYHA class II. Consistently, mean LVEF increased to 37.9%. The percentage of S/V patients with LVEF &lt;22.5% decreased from 11.5% to 5.8%. KCCQ overall summary score increased by 1.9 points. An improvement of ≥5 points, denoting a clinically meaningful increase, was reported for 36.2% of S/V patients. Conclusions Data from the ARIADNE prospective registry portray a diverse, multinational study cohort receiving sacubitril/valsartan under real-world conditions. Throughout the study, symptoms and quality of life improved with the use of S/V. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis AG, Switzerland

scholarly journals Long-term survival with tafamidis in patients with transthyretin amyloid cardiomyopathy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Damy ◽  
P Elliott ◽  
B Gundapaneni ◽  
S See Tai ◽  
M.B Sultan ◽  
...  
Keyword(s):  
Median Survival ◽  
Free Acid ◽  
Funding Source ◽  
Private Company ◽  
Heart Transplants ◽  
Term Survival ◽  
Long Term Survival ◽  
All Cause Mortality ◽  
Amyloid Cardiomyopathy

Abstract Background The Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), demonstrated that tafamidis was an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Tafamidis, at an 80 mg daily dose, was subsequently approved in several countries for the treatment of ATTR-CM. Patients who completed ATTR-ACT were eligible to enroll in an ongoing long-term extension study (LTE) which provides additional data on the long-term efficacy of tafamidis. Purpose To assess the long-term benefit of tafamidis in patients with ATTR-CM and to determine median survival times with treatment. Methods Patients with ATTR-CM who completed ATTR-ACT (in which they were randomized to tafamidis meglumine 80 mg, 20 mg or placebo for 30 months) could enroll in the ongoing LTE in which patients continued to be treated with the same dose of tafamidis or, if previously treated with placebo, were randomized to tafamidis meglumine 80 mg or 20 mg. Tafamidis free acid 61 mg is a new formulation (bioequivalent to tafamidis meglumine 80 mg) developed for patient convenience and all patients in the LTE transitioned to tafamidis free acid 61 mg as of 1 Aug, 2018. All-cause mortality (with heart transplant or cardiac mechanical assist device [CMAD] implantation counted as death) was assessed using a Cox proportional hazards model (as of 1 Aug, 2019). Patients treated with tafamidis meglumine 80 mg in ATTR-ACT and the LTE who transitioned to tafamidis free acid 61 mg (tafamidis 80/61 mg) were compared with patients treated with placebo in ATTR-ACT who transitioned to tafamidis in the LTE (placebo/tafamidis). Results There were a total of 176 tafamidis 80/61 mg patients and 177 placebo/tafamidis patients. Median treatment duration was 51.9 months with tafamidis 80/61 mg and 51.4 months with placebo/tafamidis. With tafamidis 80/61 mg, there were 75 (42.6%) all-cause deaths; consisting of 67 (38.1%) deaths, 6 (3.4%) heart transplants, and 2 (1.1%) CMAD implantations. With placebo/tafamidis, there were 108 (61.0%) all-cause deaths; consisting of 102 (57.6%) deaths and 6 (3.4%) heart transplants. There was a significant reduction of 41.1% in the risk of all-cause mortality with tafamidis 80/61 mg compared with placebo/tafamidis (hazard ratio [95% CI], 0.5888 [0.4370, 0.7931]; P=0.0004). Median survival time with placebo/tafamidis was 35.8 months but was not reached with tafamidis 80/61 mg. Conclusions Treatment with tafamidis significantly improves long-term survival in patients with ATTR-CM. The comparatively poorer survival in patients treated with placebo in ATTR-ACT who transitioned to tafamidis in the LTE highlights the importance of early diagnosis and treatment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer.

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