Projecting the long-term benefits of single pill combination therapy for patients with hypertension in five countries

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Borghi ◽  
J.G Wang ◽  
A.V Rodionov ◽  
M Rosas ◽  
I.S Sohn ◽  
...  
Keyword(s):  
Combination Therapy ◽  
South Korea ◽  
Health Outcomes ◽  
Clinical Outcomes ◽  
Funding Source ◽  
Combination Therapies ◽  
Private Company ◽  
Treatment Pathways ◽  
Single Pill ◽  
The Impact

Abstract Background It is well established that single pill combination (SPC) therapies have the potential to improve patient adherence versus multi-pill regimens, thereby improving blood pressure control and clinical outcomes in populations with hypertension. Purpose To develop a microsimulation model, capturing different treatment pathways, to project the impact on clinical outcomes of using single pill combination therapies for the management of hypertension in five countries (Italy, Russia, China, South Korea and Mexico). Methods The model was designed to project health outcomes between 2020 and 2030 for populations with hypertension managed according to four different treatment pathways: current treatment practices [CTP], single drug with dosage titration first then sequential addition of other agents [start low and go slow, SLGS], free choice combination with multiple pills [FCC] and combination therapy in the form of a single pill [SPC]. Model inputs were derived from Global Burden of Disease 2017 dataset, including demographics, health status/risk factors, transition probabilities and treatment attributes/healthcare utilization, and the model incorporated real-world challenges to healthcare delivery such as access to care, SBP measurement error, adherence and therapeutic inertia. Simulated outcomes of mortality, incidence of chronic kidney disease (CKD), stroke and ischemic heart disease (IHD), and disability-adjusted life years (DALYs) due to these conditions were estimated for population of 1,000,000 simulated patients for each treatment pathway and country. Results SPC therapy was projected to improve health outcomes over SLGS, FCC and CTP over 10 years in all five countries. SPC was forecast to reduce mortality by 5.4% (Italy), 4.9% (Russia), 4.5% (China), 2.3% (South Korea) and 3.6% (Mexico) versus CTP and showed greater projected reductions in mortality than SLGS and FCC. DALYs were projected to be reduced with SPC therapy by between 5.7% (Italy) and 2.2% (South Korea) compared with CTP and reductions in the incidence of clinical events were also projected with SPC therapy, with decreases in the range of 11.5% (Italy) to 4.9% (South Korea) versus CTP. Conclusions Ten-year projections of clinical outcomes associated with different anti-hypertensive treatment pathways in five countries indicated that both combination therapies (FCC and SPC) are likely to reduce the disease burden of hypertension compared with conventional management approaches, with SPC showing the greatest overall benefits due to improved adherence. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi, Gentilly, France

Artificial intelligence-guided image acquisition on patients with implanted electrophysiological devices: results from a pivotal prospective multi-center clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Surette ◽  
A Narang ◽  
R Bae ◽  
H Hong ◽  
Y Thomas ◽  
...  
Keyword(s):  
Qualitative Assessment ◽  
Funding Source ◽  
Software Performance ◽  
Private Company ◽  
Diagnostic Quality ◽  
Icd Leads ◽  
Significant Difference ◽  
Level 3 ◽  
And Function ◽  
The Impact

Abstract Background A novel, recently FDA-authorized software uses deep learning (DL) to provide prescriptive transthoracic echocardiography (TTE) guidance, allowing novices to acquire standard TTE views. The DL model was trained by >5,000,000 observations of the impact of probe motion on image orientation/quality. This study evaluated whether novice-acquired TTE images guided by this software were of diagnostic quality in patients with and without implanted electrophysiological (EP) devices, focusing on RV size and function, which were thought to be sensitive to EP devices. Some aspects of the study have previously been presented. Methods 240 patients (61±16 years old, 58% male, 33% BMI >30 kg/m2, 91% with cardiac pathology) were recruited. 8 nurses without echo experience each acquired 10 view TTEs in 30 patients guided by the software. 235 of the patients were also scanned by a trained sonographer without assistance from the software. 5 Level 3 echocardiographers independently assessed the diagnostic quality of the TTEs acquired by the nurses and sonographers to evaluate the effect of EP devices on DL software performance. Results Nurses using the AI-guided acquisition software acquired TTEs of sufficient quality to make qualitative assessments of right ventricular (RV) size and function in greater than 80% of cases for patients with and without implanted EP devices (Table). There was no significant difference between nurse- and sonographer-acquired scans. Conclusion These results indicate that new DL software can guide novices to obtain TTEs that enable qualitative assessment of RV size even in the presence of implanted EP devices. The results of the comparison to sonographer-acquired exams indicate the software performance is robust to presence of pacemaker/ICD leads visible in the images (Figure). Nurse-acquired TTE with visible ICD lead Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Caption Health, Inc.

The role of single pill combination therapy in the prevention of ischaemic stroke

2019 ◽  
Vol 64 (4) ◽  
pp. 126-132
Author(s):  
Wan Y Ho ◽  
Azmil H Abdul-Rahim ◽  
Jesse Dawson ◽  
Alan C Cameron
Keyword(s):  
Combination Therapy ◽  
Clinical Outcomes ◽  
Stroke Prevention ◽  
Healthcare Professionals ◽  
Evidence Base ◽  
Stroke Survivors ◽  
Perceived Benefit ◽  
Single Pill ◽  
Individualised Care

Background and aims The role of single pill combination therapy for stroke prevention remains to be established. We explored the perspectives of stroke survivors and healthcare professionals on single pill combination therapy for stroke prevention. Methods We conducted focus groups involving stroke survivors and healthcare professionals. Results We recruited six stroke survivors: four (67%) were female and mean age was 70 ± 12 years; and eight healthcare professionals (three Stroke Consultants, two Nurse Specialists, three General Practitioners). Improved adherence is the main perceived benefit of single pill combination therapy, although concerns exist surrounding less individualised care, unsuitability for use in the acute setting, reduced ability to titrate doses and difficulty identifying the cause of side effects. The clinical stability of patients, alongside single pill combination therapy efficacy, cost, side effect profile and evidence base for impact on risk factors and clinical outcomes are key factors influencing acceptability. Stroke survivors and healthcare professionals feel single pill combination therapy is most suitable for stable patients, although there is no evidence base for its use in this context. Conclusion Stroke healthcare professionals and stroke survivors are most amenable to using single pill combination therapy for stable patients, although its role in this context should be evaluated in studies with risk factor targets and clinical outcomes as endpoints.

Use of a modified Delphi panel to define value of combination therapy in oncology.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18369-e18369
Author(s):  
Michael Broder ◽  
Harshali Patel ◽  
Zac Wessler ◽  
Sarah Gibbs ◽  
Irina Yermilov ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Health Outcomes ◽  
Cultural Beliefs ◽  
Unmet Need ◽  
Delphi Panel ◽  
Combination Therapies ◽  
Cancer Treatments ◽  
Treatment Regimens ◽  
Modified Delphi ◽  
Tumor Types

e18369 Background: Treatment regimens involving 2+ novel oncologics have improved health outcomes in several tumor types. These regimens have significantly higher costs than single agents and older treatments (e.g., chemotherapies), which are still widely used to treat different cancers. Our goal was to determine if current concepts of “value,” such as those described by ICER and other frameworks, adequately capture the value of combination therapies. Methods: Using a RAND/UCLA modified Delphi panel, 8 experts from various backgrounds were provided with a review of current concepts of value and asked to rate them on measurability, relevance, and necessity to determine a combination therapy’s value from 4 perspectives (patient, physician, payer, society). After the first round of ratings, panelists met in person and discussed areas of disagreement. Ratings were repeated, and results used to quantitatively summarize group opinion on concepts recommended for inclusion in a value definition. Results: In both rating rounds, experts agreed treatment, clinical evidence, and health outcomes as important domains in determining value. Experts disagreed on whether societal/cultural beliefs, disease factors (i.e., rarity of cancer, unmet need, burden of disease), and other elements of value (e.g., insurance value, reduction in uncertainty, treatment affordability) needed to be incorporated into value assessments of combinations. Responses differed by perspective. Concepts on which there was disagreement decreased post-meeting (23% to 9%). Conclusions: Experts agreed that “value” for 2+ novel oncologics would have a similar definition to value for all high cost oncology therapies. Four key research opportunities to characterize the value of combination therapy emerged: societal context and patient preference may affect value assessments but are not widely considered in current models; some important benefits are not recognized by patients and may be missed by traditional value assessments; given typical patient and societal preferences, cancer treatments may be systematically undervalued vis a vis other health conditions; and combination therapies may present challenges for recently promulgated value frameworks.

scholarly journals Characterizing Dual Combination Therapy Use in Treatment Escalation of Hypertension: Real-World Evidence from Multinational Cohorts

2021 ◽  
Author(s):  
Yuan Lu ◽  
Jing Li ◽  
Xialin Wang ◽  
Sreemanee Raaj Dorajoo ◽  
Mengling Feng ◽  
...  
Keyword(s):  
Combination Therapy ◽  
South Korea ◽  
Beta Blocker ◽  
Real World ◽  
Antihypertensive Agents ◽  
The United States ◽  
Future Research ◽  
Routine Practice ◽  
Combination Therapies ◽  
History Of

ABSTRACT Background: Over one billion adults have hypertension globally, of whom approximately 70% cannot achieve blood pressure control goal with monotherapy alone. Data are lacking on patterns of dual combination therapies prescribed to patients who escalate from monotherapy in routine practice. Methods: Using eleven electronic health record databases that cover 118 million patients across eight countries/regions, we characterized the initiation of antihypertensive dual combination therapies for patients with hypertension. In each database, we first constructed twelve exposure cohorts of patients who newly initiate dual combination therapy with one of the four most commonly used antihypertensive drug classes (angiotensin-converting enzyme inhibitor [ACEi] or angiotensin receptor blocker [ARB]; calcium channel blocker [CCB]; beta-blocker; and thiazide or thiazide-like diuretic) after escalating from monotherapy with one of the three alternative classes. Using these cohorts, we then described dual combination therapy utilization, stratified by age, gender, history of cardiovascular diseases (CVD), and country. Results: Across data sources, we identified 980,648 patients with hypertension initiating dual combination therapy with antihypertensive agents after escalating from monotherapy: 12,541 from Australia, 6,980 from South Korea, 2,096 from Singapore, 7,008 from China, 16,663 from Taiwan, 103,994 from France, 76,082 from Italy, and 754,137 from the United States (US). Significant variations in treatment utilization existed across countries and patient subgroups. In Australia and Singapore, starting an ACEi/ARB monotherapy followed by a CCB was most common while in South Korea, China and Taiwan, starting a CCB monotherapy followed by an ACEi/ARB was most common. In Italy, France, and the US, sequential use of an ACEi/ARB monotherapy followed by a diuretic was most common. Younger patients were more likely to be prescribed ACEi/ARB followed by either a CCB or a diuretic compared with older patients. Women were more likely to be prescribed diuretics then an ACEi/ARB or a CCB compared with men. Among patients with history of CVD, ACEi/ARB followed by beta-blocker, and beta-blocker followed by ACEi/ARB were more commonly prescribed. Conclusion: This is the largest and most comprehensive study characterizing the real-world utilization of dual combination therapies in treating hypertension. Large variation in the transition between monotherapy and dual combination therapy for hypertension was observed across countries. These results highlight the need for future research to identify which second-line dual combination therapy is most effective in practice.

scholarly journals Semi-mechanistic pharmacokinetic and pharmacodynamic modelling of piperaquine in a volunteer infection study with Plasmodium falciparum blood-stage malaria

2021 ◽  
Author(s):  
Thanaporn Wattanakul ◽  
Mark Baker ◽  
Joerg Mohrle ◽  
Brett McWhinney ◽  
Richard M. Hoglund ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
Combination Therapy ◽  
Multidrug Resistant ◽  
Pharmacodynamic Model ◽  
Blood Stage ◽  
Maximum Effect ◽  
Combination Therapies ◽  
Triple Combination Therapy ◽  
The Impact ◽  
Parasite Dynamics

Dihydroartemisinin-piperaquine is a recommended first-line artemisinin combination therapy for falciparum malaria. Piperaquine is also under consideration for other antimalarial combination therapies. The aim of this study was to develop a pharmacokinetic-pharmacodynamic model that could be used to optimize the use of piperaquine in new antimalarial combination therapies. The pharmacokinetic-pharmacodynamic model was developed using data from a previously reported dose-ranging study where 24 healthy volunteers were inoculated 1,800 blood-stage Plasmodium falciparum parasites. All volunteers received a single oral dose of piperaquine (960 mg, 640 mg, or 480 mg) on day 7 or day 8 after parasite inoculation in separate cohorts. Parasite densities were measured by qPCR, and piperaquine levels were measured in plasma samples. We used nonlinear mixed-effect modelling to characterize the pharmacokinetic properties of piperaquine and the parasite dynamics associated with piperaquine exposure. Pharmacokinetics of piperaquine was described by a three-compartment disposition model. A semi-mechanistic parasite dynamics model was developed to explain maturation of parasites, sequestration of mature parasites, synchronicity of infections, and multiplication of parasites, as seen in natural clinical infections with falciparum malaria. Piperaquine-associated parasite killing was estimated using a maximum effect (Emax) function. Treatment simulations (i.e. 3-day oral dosing of dihydroartemisinin-piperaquine) indicated that to be able to combat multidrug resistant infections, an ideal additional drug in a new antimalarial triple-combination therapy should have a parasite reduction ratio of ≥102 per life cycle (38.8 h) with a duration of action of ≥ 2 weeks. The semi-mechanistic pharmacokinetic-pharmacodynamic model described here offers the potential to be a valuable tool to assess and optimize current and new antimalarial drug combinations therapies containing piperaquine, and the impact of these therapies on killing multidrug resistant infections.

scholarly journals First-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of BMS-986177/JNJ-70033093, a direct, reversible, small molecule Factor XIa inhibitor in healthy volunteers

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Perera ◽  
Z Wang ◽  
J Luettgen ◽  
J Wang ◽  
D Li ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Healthy Volunteers ◽  
Small Molecule ◽  
Healthy Subjects ◽  
Funding Source ◽  
Private Company ◽  
Factor Xia ◽  
Clinically Significant ◽  
Oral Doses ◽  
The Impact

Abstract Background Inhibition of Factor XIa (FXIa) may provide a novel mechanism for systemic anticoagulation without increasing the risk of clinically significant bleeding in many conditions predisposing to a high risk of thrombotic or bleeding events. BMS-986177/JNJ-70033093 (BMS-177/JNJ-3093) is a small molecule that inhibits FXIa with high affinity and selectivity. Depending on the indication, BMS-177/JNJ-3093 may provide benefit to patients as add-on therapy to current standard of care (SOC) antithrombotic agents or potentially as a replacement for current SOC. Purpose To assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of BMS-177/JNJ-3093 in healthy subjects. Methods This was a 2-part, randomized, double-blind, placebo-controlled, sequential single- (Part A) and multiple- (Part B) ascending dose study to assess the safety, tolerability, PK, and PD of BMS-177/JNJ-3093 in healthy subjects. In Part A (SAD) of the study, 48 subjects were treated in 6 panels (8 subjects per panel). The 200 mg and 500 mg dose panels investigated the impact of a high fat diet on PK. In Part B (MAD), 56 subjects were treated in 7 panels (8 subjects per panel) on a once daily (QD) or twice daily (BID) regimen for a 14-day period. Within each panel in Parts A and B, subjects were randomized to receive either BMS-177/JNJ-3093 or matched placebo (3:1). Results Administration of single ascending doses of BMS-177/JNJ-3093 up to 500 mg and multiple ascending doses of BMS-177/JNJ-3093 up to 200 mg BID or 500 mg QD for 14 days were safe and well tolerated. No subjects had a clinically significant bleeding event. All treatment-emergent adverse events were mild in severity. After single doses of BMS-177/JNJ-3093 ranging from 4 to 500 mg in fasted status, BMS-177/JNJ-3093 plasma concentration reached Cmax at 3 h postdose in all panels, indicating a similar rate of absorption. The terminal half-life ranged from 8.26 to 13.8 h across SAD panels. Over 20 to 200 mg, a dose proportional increase was observed; however, saturable absorption was seen at higher doses of 300 and 500 mg. Food also increased the bioavailability of BMS-177/JNJ-3093. In the MAD portion of the study, based on visual inspection of trough plasma concentration profiles, BMS-177/JNJ-3093 plasma concentration steady state was reached between 1–3 dosing days (ie, Days 2–4) for the QD panels and 6 dosing days (ie, Day 7) for the 200 mg BID panel. Renal excretion was relatively low, ranging from 8–20%. After single oral dose or multiple oral doses, there is a clear trend that aPTT was prolonged and the magnitude of change was related to drug exposure. Conclusion BMS-177/JNJ-3093 was safe and well tolerated in healthy volunteers. The PK and PD profile demonstrates suitable dosing properties for further clinical studies. Currently, two Phase II studies are ongoing. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This work was sponsored by Bristol-Myers Squibb and Janssen Research & Development, LLC

Ten years of high-sensitivity cardiac troponin testing in the Netherlands: impact on the diagnosis of myocardial infarction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.M Kimenai ◽  
Y Appelman ◽  
H.M Den Ruijter ◽  
N.L Mills ◽  
S.J.R Meex
Keyword(s):  
Myocardial Infarction ◽  
The Netherlands ◽  
Cardiac Troponin ◽  
High Sensitivity ◽  
Funding Source ◽  
Private Company ◽  
Absolute Change ◽  
Before And After ◽  
One Year ◽  
The Impact

Abstract Introduction High-sensitivity cardiac troponin (hs-cTn) assays have enhanced sensitivity for myocardial injury and may lead to an increase in the diagnosis of myocardial infarction. Few real-world studies have investigated the transition from conventional cardiac troponin (cTn) to hs-cTn. We evaluated the impact of implementing hs-cTn assays and sex-specific thresholds in the Netherlands on the diagnosis of myocardial infarction in women and men. Methods Twelve Dutch hospitals were included (hs-cTnI assay [sex-specific thresholds], n=4; hs-cTnT assay [uniform threshold], n=8). Data from the health insurance claims of consecutive patients with anginal symptoms were collected before (cTn period) and after (hs-cTn period) implementation from January 2008 to December 2017. The proportion of patients with a diagnosis of myocardial infarction overall, and in men and women separately, and one-year mortality was compared before and after implementation of the hs-cTn assay. Results Across twelve hospitals, a total number of 77,464 patients presenting with anginal symptoms were included (cTn period: 35,409 [36.6% women]; hs-cTn period: 42,055 [34.6% women]). Following implementation of hs-cTn testing the proportion of patients with anginal symptoms diagnosed with myocardial infarction doubled from 24% (3,111/12,970) to 48% (7,014/14,560) in women, and from 25% (5,712/22,439) to 51% (13,912/27,495) in men, with similar increases in sites implementing hs-cTnI and hs-cTnT. The proportion of patients diagnosed with myocardial infarction who were women increased in sites implementing sex-specific thresholds (from 36.4% [1,435/3,941] to 37.5% [1,700/4,532], absolute change 1.1%), but did not increase in sites using a uniform threshold (from 34.3% [1,676/4,882] to 32.4% [5,314/16,394], absolute change −1.9%). In patients with a diagnosis of myocardial infarction, one-year mortality was 15.6% (485/3,111) and 11.6% (814/7,014) in women, and was 11.8% (673/5,712) and 9.4% (1,303/13,912) in men, before and after implementation of hs-cTn. Conclusions In patients presenting with anginal symptoms, the diagnosis of acute myocardial infarction doubled after implementation of hs-cTn testing in both women and men. Use of sex-specific thresholds increased the proportion of patients with myocardial infarction who were women compared to use of a uniform threshold. Implementation was associated with a reduction in one-year mortality, but further research is needed to understand whether this is due to differences in the risk profile of patients with myocardial infarction or improvements in treatment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was supported by a grant from Abbott Laboratories to S.J.R.M.

Long-term prognostic benefit of beta-blockers use after discharge in patients with Tako-Tsubo syndrome

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Jamhour-Chelh ◽  
S Raposeiras-Roubin ◽  
I Nunez-Gil ◽  
E Abu-Assi ◽  
D Aritza Conty ◽  
...  
Keyword(s):  
Large Scale ◽  
Beta Blockers ◽  
Funding Source ◽  
Prognostic Impact ◽  
Private Company ◽  
Cox Analysis ◽  
The Impact ◽  
Long Term Mortality

Abstract Background Tako-tsubo Syndrome (TS) seems to be associated with a catecholamine-mediated mechanism. However, the impact of beta-blockers (BB) in-hospital and after discharge still remain uncertain. Objectives: The purpose of the study was to examine whether BB use after discharge in patients with TS, was associated with lower long-term mortality and recurrence. Methods Using a national multicentre large-scale inpatient database (RETAKO Registry), we analysed patients with a definitive TS diagnosis. Results A total of 970 patients were analysed (568 with BB therapy and 402 no-BB therapy). After discharge and over a median of follow-up of 1.1 years, treatment with BB have no shown prognostic effectiveness in terms of mortality and TS recurrence in unadjusted and adjusted Cox analysis (HR 0.86; 95% CI: 0.59 to 1.27; and 0.95; 95% CI: 0.57–1.13, respectively). Conclusions This data suggests that use of beta-blockers after hospital discharge has not shown long-term prognostic benefit in patients with Tako-tsubo Syndrome. Prognostic impact of BB in TS. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Retako webpage was funded by a non-conditioned Astrazeneca scholarship.

scholarly journals The Impact of Morbid Obesity on the Health Outcomes of Hospital Inpatients: An Observational Study

2021 ◽  
Vol 10 (19) ◽  
pp. 4382
Author(s):  
Kellie Fusco ◽  
Campbell Thompson ◽  
Richard Woodman ◽  
Chris Horwood ◽  
Paul Hakendorf ◽  
...  
Keyword(s):  
Morbid Obesity ◽  
Health Outcomes ◽  
Clinical Outcomes ◽  
Length Of Hospital Stay ◽  
P Value ◽  
Morbidly Obese ◽  
Obese Patients ◽  
Hospitalised Patients ◽  
Nutritional Data ◽  
The Impact

Morbid obesity poses a significant burden on the health-care system. This study determined whether morbid obesity leads to worse health-outcomes in hospitalised patients. This retrospective-study examined nutritional data of all inpatients aged 18–79 years, with a body-mass-index (BMI) ≥ 18.5 kg/m2 admitted over a period of 4 years at two major hospitals in Australia. Patients were divided into 3 groups for comparison: normal/overweight (BMI 18.5–29.9 kg/m2), obese (BMI 30–39.9 kg/m2) and morbidly-obese (BMI ≥ 40 kg/m2). Outcome measures included length-of-hospital-stay (LOS), in-hospital mortality, and 30-day readmissions. Multilevel-mixed-effects regression was used to compare clinical outcomes between the groups after adjustment for potential confounders. Of 16,579 patients, 1004 (6.1%) were classified as morbidly-obese. Morbidly-obese patients had a significantly longer median (IQR) LOS than normal/overweight patients (5 (2, 12) vs. 5 (2, 11) days, p value = 0.012) and obese-patients (5 (2, 12) vs. 5 (2, 10) days, p value = 0.036). After adjusted-analysis, morbidly-obese patients had a higher incidence of a longer LOS than normal/overweight patients (IRR 1.04; 95% CI 1.02–1.07; p value < 0.001) and obese-patients (IRR 1.13; 95% CI 1.11–1.16; p value < 0.001). Other clinical outcomes were similar between the different groups. Morbid obesity leads to a longer LOS in hospitalised patients but does not adversely affect other clinical outcomes.

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

Sign in / Sign up

Export Citation Format

Share Document