scholarly journals Accuracy of a smartwatch based single-lead electrocardiogram device in detection of atrial fibrillation

Heart ◽  
2020 ◽  
Vol 106 (9) ◽  
pp. 665-670 ◽  
Author(s):  
Kevin Rajakariar ◽  
Anoop N Koshy ◽  
Jithin K Sajeev ◽  
Sachin Nair ◽  
Louise Roberts ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Predictive Value ◽  
Cardiac Rhythm ◽  
Hospital Setting ◽  
Automated Diagnosis ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Automated Algorithms ◽  
Improved Accuracy

ObjectiveThe AliveCor KardiaBand (KB) is an Food and Drug Administration-approved smartwatch-based cardiac rhythm monitor that records a lead-Intelligent ECG (iECG). Despite the appeal of wearable integrated ECG devices, there is a paucity of data evaluating their accuracy in diagnosing atrial fibrillation (AF). We evaluated whether a smartwatch-based device for AF detection is an accurate tool for diagnosing AF when compared with 12-lead ECG.MethodsA prospective, multi-centre, validation study was conducted in an inpatient hospital setting. The KB paired with a smartwatch, generated an automated diagnosis of AF or sinus rhythm (SR). This was compared with a 12-lead ECG performed immediately after iECG tracing. Where an unclassified or no-analysis tracing was generated, repeat iECG was performed.Results439 ECGs (iECGs (n=239) and 12-lead ECG (n=200)) were recorded in 200 patients (AF: n=38; SR: n=162) from three tertiary centres. Sensitivity and specificity using KB was 94.4% and 81.9% respectively, with a positive predictive value of 54.8% and negative predictive value of 98.4%. Agreement between 12-lead ECG and KB diagnosis was moderate when unclassified tracings were included (κ=0.60, 95% CI 0.47 to 0.72). Combining the automated device diagnosis with blinded electrophysiologists (EP) interpretation of unclassified tracings improved overall agreement (EP1: κ=0.76, 95% CI 0.65 to 0.87; EP2: κ=0.74, 95% CI 0.63 to 0.86).ConclusionThe KB demonstrated moderate diagnostic accuracy when compared with a 12-lead ECG. Combining the automated device diagnosis with EP interpretation of unclassified tracings yielded improved accuracy. However, even with future improvements in automated algorithms, physician involvement will likely remain an essential component when exploring the utility of these devices for arrhythmia screening.Clinical trial registrationURL: https://www.anzctr.org.au/ Unique identifier: ACTRN12616001374459.

scholarly journals The association of novel inflammatory marker GlycA and incident atrial fibrillation in the Multi-Ethnic Study of Atherosclerosis (MESA)

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248644
Author(s):  
Sunyoung Jang ◽  
Oluseye Ogunmoroti ◽  
Di Zhao ◽  
Oluwaseun E. Fashanu ◽  
Martin Tibuakuu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Inflammatory Markers ◽  
Inflammatory Marker ◽  
Individual Variability ◽  
Cvd Risk ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Link Type ◽  
The Mean

Background Emerging evidence has implicated that inflammation contributes to the pathogenesis of atrial fibrillation (AF). GlycA is a novel marker of systemic inflammation with low intra-individual variability and high analytic precision. GlycA has been associated with incident cardiovascular disease (CVD) independent of other inflammatory markers. However, whether GlycA is associated with AF, specifically, has yet to be established. We examined the association between GlycA and AF in a multi-ethnic cohort. Methods We studied 6,602 MESA participants aged 45–85, with no clinical CVD at baseline, with data on GlycA and incident AF. We used multivariable-adjusted Cox models to evaluate the association between GlycA and incident AF. We also examined other inflammatory markers [high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL6) and fibrinogen] and incident AF for comparison. Results The mean (SD) age was 62 (10) years, 53% women. The mean plasma GlycA was 381 (62) μmol/L. Over median follow-up of 12.9 years, 869 participants experienced AF. There was no statistically significant association between GlycA and incident AF after adjusting for sociodemographics, CVD risk factors, and other inflammatory markers [Hazard Ratio (95% CI) per 1 SD increment in GlycA: 0.97 (0.88–1.06)]. Neither hsCRP nor fibrinogen was associated with incident AF in same model. In contrast, IL-6 was independently associated with incident AF [HR 1.12 per 1 SD increment (1.05–1.19)]. Conclusions Although GlycA has been associated with other CVD types, we found that GlycA was not associated with AF. More research will be required to understand why IL-6 was associated with AF but not GlycA. Clinical trial registration MESA is not a clinical trial. However, the cohort is registered at: URL: https://clinicaltrials.gov/ct2/show/NCT00005487 Unique identifier: NCT00005487.

scholarly journals Incidence and Predictors of Hospitalization in Patients with Atrial Fibrillation: Results from the Chinese Atrial Fibrillation Registry Study

2020 ◽  
Author(s):  
Zhaojie Dong ◽  
Xin Du ◽  
Shangxin Lu ◽  
Chao Jiang ◽  
Shijun Xia ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiovascular Diseases ◽  
Proportional Hazards Model ◽  
Cox Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Chronic Obstructive ◽  
Unique Identifier ◽  
Clinical Trial Registration

Abstract Background: Patients with atrial fibrillation (AF) underwent a high risk of hospitalization, which, however, has not been paid much attention in clinic. Therefore, we aimed to assess the incidence, causes and predictors of hospitalization in AF patients.Methods: From August 2011 to December 2017, 20,172 AF patients from the Chinese Atrial Fibrillation Registry (China-AF) Study were enrolled in this study. We described the incidence, causes of hospitalization according to age and gender categories. The Cox proportional hazards model was employed to identify predictors of first all-cause and first cause-specific hospitalization. Results: After a mean follow-up of 37.3 ± 20.4 months, 7,512 (37.2%) AF patients experienced one or more hospitalizations. The overall incidence of all-cause hospitalization was 24.0 per 100 patient-years. Patients aged < 65 years were predominantly hospitalized for AF (42.1% of the total frequency of hospitalizations); while patients aged 65-74 and ≥ 75 years were mainly hospitalized for non-cardiovascular diseases (43.6% and 49.3%, respectively). Multivariate Cox model analysis verified the higher risk of hospitalization in patients complicated with heart failure (HF)[hazard ratio (HR) 1.15, 95% confidence interval (CI) 1.08-1.24], established coronary artery disease (CAD) (HR 1.26, 95%CI 1.19-1.34), ischemic stroke/transient ischemic attack (TIA) (HR 1.26, 95%CI 1.18-1.33), diabetes (HR 1.16, 95%CI 1.10-1.22), chronic obstructive pulmonary disease (COPD) (HR 1.41, 95%CI 1.13-1.76), gastrointestinal disorder (HR 1.39, 95%CI 1.23-1.58), and renal dysfunction (HR 1.31, 95%CI 1.16-1.48). Conclusions: More than one-third of AF patients included in this study were hospitalized at least once during almost 3 years of follow-up. The main cause for hospitalization among elderly patients (≥65 years) is non-cardiovascular diseases rather than AF. Multidisciplinary management of comorbidities should be advocated as strategies to reduce hospitalization in AF patients.Clinical Trial Registration: URL: http://www.chictr.org.cn/showproj.aspx?proj=5831. Unique identifier: ChiCTR-OCH-13003729.

scholarly journals Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis

Circulation ◽  
2019 ◽  
Vol 140 (18) ◽  
pp. 1451-1459 ◽  
Author(s):  
John W. Eikelboom ◽  
Stuart J. Connolly ◽  
Jacqueline Bosch ◽  
Olga Shestakovska ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gastrointestinal Bleeding ◽  
Cancer Diagnosis ◽  
Minor Bleeding ◽  
Antithrombotic Drugs ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Risk Of Bleeding ◽  
Genitourinary Cancer

Background: Patients treated with antithrombotic drugs are at risk of bleeding. Bleeding may be the first manifestation of underlying cancer. Methods: We examined new cancers diagnosed in relation to gastrointestinal or genitourinary bleeding among patients enrolled in the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) and determined the hazard of new cancer diagnosis after bleeding at these sites. Results: Of 27 395 patients enrolled (mean age, 68 years; women, 21%), 2678 (9.8%) experienced any (major or minor) bleeding, 713 (2.6%) experienced major bleeding, and 1084 (4.0%) were diagnosed with cancer during a mean follow-up of 23 months. Among 2678 who experienced bleeding, 257 (9.9%) were subsequently diagnosed with cancer. Gastrointestinal bleeding was associated with a 20-fold higher hazard of new gastrointestinal cancer diagnosis (7.4% versus 0.5%; hazard ratio [HR], 20.6 [95% CI, 15.2–27.8]) and 1.7-fold higher hazard of new nongastrointestinal cancer diagnosis (3.8% versus 3.1%; HR, 1.70 [95% CI, 1.20–2.40]). Genitourinary bleeding was associated with a 32-fold higher hazard of new genitourinary cancer diagnosis (15.8% versus 0.8%; HR, 32.5 [95% CI, 24.7–42.9]), and urinary bleeding was associated with a 98-fold higher hazard of new urinary cancer diagnosis (14.2% versus 0.2%; HR, 98.5; 95% CI, 68.0–142.7). Nongastrointestinal, nongenitourinary bleeding was associated with a 3-fold higher hazard of nongastrointestinal, nongenitourinary cancers (4.4% versus 1.9%; HR, 3.02 [95% CI, 2.32–3.91]). Conclusions: In patients with atherosclerosis treated with antithrombotic drugs, any gastrointestinal or genitourinary bleeding was associated with higher rates of new cancer diagnosis. Any gastrointestinal or genitourinary bleeding should prompt investigation for cancers at these sites. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01776424.

scholarly journals Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients

Stroke ◽  
2018 ◽  
Vol 49 (12) ◽  
pp. 2933-2944 ◽  
Author(s):  
Gregory Y.H. Lip ◽  
Allison Keshishian ◽  
Xiaoyan Li ◽  
Melissa Hamilton ◽  
Cristina Masseria ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Observational Study ◽  
Oral Anticoagulants ◽  
Healthcare Providers ◽  
Pooled Analysis ◽  
Nonvalvular Atrial Fibrillation ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Cox Models ◽  
Multiple Data

Background and Purpose— This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non–vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods— A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts. Results— A total of 434 046 patients were included in the 6 matched cohorts: 100 977 apixaban-warfarin, 36 990 dabigatran-warfarin, 125 068 rivaroxaban-warfarin, 37 314 apixaban-dabigatran, 107 236 apixaban-rivaroxaban, and 37 693 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.64; 95% CI, 0.58–0.70), dabigatran (HR, 0.82; 95% CI, 0.71–0.95), and rivaroxaban (HR, 0.79; 95% CI, 0.73–0.85) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.60; 95% CI, 0.56–0.63) and dabigatran (HR, 0.71; 95% CI, 0.65–0.78) had lower rates of MB, and rivaroxaban (HR, 1.06; 95% CI, 1.02–1.10) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs. Conclusions— In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients. Clinical Trial Registration— URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT03087487.

Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

Heart ◽  
2018 ◽  
Vol 104 (15) ◽  
pp. 1292-1299 ◽  
Author(s):  
Dragos Vinereanu ◽  
Alice Wang ◽  
Hillary Mulder ◽  
Renato D Lopes ◽  
Petr Jansky ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Major Bleeding ◽  
Treatment Effect ◽  
P Value ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Clinical Trial Registration ◽  
Safety Outcomes ◽  
Anticoagulated Patients

ObjectiveTo assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.MethodsThere were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model.ResultsPatients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory.ConclusionsIn anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.Clinical trial registrationARISTOTLE clinical trial number NCT00412984.

scholarly journals A Randomized Comparison of Delivered Energy in Cardioversion of Atrial Fibrillation: Biphasic Truncated Exponential versus Pulsed Biphasic Waveforms

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1107
Author(s):  
Elina Trendafilova ◽  
Elena Dimitrova ◽  
Jean-Philippe Didon ◽  
Vessela Krasteva
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
High Energy ◽  
Success Rates ◽  
Clinical Trial Registration ◽  
Fixed Energy ◽  
St Segment ◽  
Registration Number ◽  
Post Shock ◽  
Baseline Characteristics

A few randomized trials have compared impedance-compensated biphasic defibrillators in clinical use. We aim to compare pulsed biphasic (PB) and biphasic truncated exponential (BTE) waveforms in a non-inferiority cardioversion (CVS) study. This was a prospective monocentric randomized clinical trial. Eligible patients admitted for elective CVS of atrial fibrillation (AF) between February 2019 and March 2020 were alternately randomized to treatment with either a PB defibrillator (DEFIGARD TOUCH7, Schiller Médical, Wissembourg, France) or a BTE high-energy (BTE-HE) defibrillator (LIFEPAK15, Physio-Control Inc., Redmond, WA, USA). Fixed-energy protocol (200–200–200 J) was administered. CVS success was accepted if sinus rhythm was restored at 1 min post-shock. The study design considered non-inferiority testing of the primary outcome: cumulative delivered energy (CDE). Seventy-three out of 78 randomized patients received allocated intervention: 38 BTE-HE (52%), 35 PB (48%). Baseline characteristics were well-balanced between groups (p > 0.05). Both waveforms had similar CDE (mean ± standard deviation, 95% confidence interval): BTE-HE (253.9 ± 120.2 J, 214–293 J) vs. PB (226.0 ± 109.8 J, 188–264 J), p = 0.31. Indeed, effective PB shocks delivered significantly lower energies by mean of 25.6 J (95% CI 24–27.1 J, p < 0.001). Success rates were similar (BTE-HE vs. PB): 1 min first-shock (84.2% vs. 82.9%), 1 min CVS (97.4% vs. 94.3%), 2 h CVS (94.7% vs. 94.3%), 24 h CVS (92.1% vs. 94.3%), p > 0.05. Safety analysis did not find CVS hazards, reporting insignificant changes of myocardial-specific biomarkers, transient and rare ST-segment deviations, and no case of harmful tachyarrhythmias and apnea. Cardioversion of AF with fixed-energy protocol 200–200–200 J was highly efficient and safe for both PB and BTE-HE waveforms. These similar performances were achieved despite differences in the waveforms’ technical design, associated with significantly lower delivered energy for the effective PB shocks. Clinical Trial Registration: Registration number: NCT04032678, trial register: ClinicalTrials.gov.

scholarly journals Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial

2020 ◽  
pp. 174749302093829
Author(s):  
Wen-Yi Huang ◽  
Meng Lee ◽  
Sheng-Feng Sung ◽  
Sung-Chun Tang ◽  
Kuo-Hsuan Chang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Randomized Clinical Trial ◽  
Paroxysmal Atrial Fibrillation ◽  
Detection Rate ◽  
Stroke Patients ◽  
Clinical Trial Registration ◽  
Detection Rates

Background Enhancing detection of unrecognized atrial fibrillation among acute ischemic stroke patients is crucial for secondary stroke prevention. Aim To evaluate whether the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation could be improved by doing serial 12-lead electrocardiograms once daily for five days, compared with conventional 24-h Holter monitoring (24-h Holter). Methods We conducted a randomized clinical trial to compare the detection rates of paroxysmal atrial fibrillation between serial electrocardiograms versus 24-h Holter from October 2015 to October 2018 at six hospitals. Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission. The primary outcome was newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group. Results Among 826 patients, baseline characteristics were similar between both groups. In the intention-to-treat analysis, there was no statistical difference between serial electrocardiograms versus 24-Holter to detect atrial fibrillation (8.4% vs. 6.9%; adjusted odds ratio 1.17, 95% confidence interval 0.69–2.01). Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. Conclusions Serial electrocardiograms had comparable detection rate of paroxysmal atrial fibrillation compared with 24-h Holter and might be a viable alternative to 24-h Holter as a first-line approach to survey for potential paroxysmal atrial fibrillation among elderly patients with acute ischemic stroke. Clinical Trial Registration: URL https://clinicaltrials.gov/ct2/show/NCT02578979 Unique Identifiers: NCT02578979

scholarly journals Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm

2020 ◽  
pp. 174749301989785 ◽  
Author(s):  
Xiaoying Chen ◽  
Jingwei Li ◽  
Craig S Anderson ◽  
Richard I Lindley ◽  
Maree L Hackett ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Logistic Regression ◽  
Outcome Measurement ◽  
Demographic Data ◽  
Weighted Kappa ◽  
Alternative Measure ◽  
Modified Rankin Scale ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Quality Of Life Scale

Background and aims The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. Methods Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. Results SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. Conclusions This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. Clinical Trial registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616.

scholarly journals Novel Supreme TM DES with Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation after DES implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial

Circulation ◽  
2021 ◽  
Author(s):  
Alexandra J. Lansky ◽  
Dean J. Kereiakes ◽  
Andreas Baumbach ◽  
Stephan Windecker ◽  
Yasin Hussain ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Clinical Trial ◽  
Absolute Risk ◽  
Target Lesion ◽  
Base Layer ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Durable Polymer ◽  
Coronary Syndromes

Background: Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug eluting stents (DES). The novel Supreme TM DES (Supreme) is designed to synchronize early drug delivery within 4-6 weeks of implantation, leaving behind a pro-healing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long term clinical outcomes is not known. Methods: In an international 2:1 randomized single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-DES) in patients with acute and chronic coronary syndromes. The primary endpoint was target lesion failure (TLF) - a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (TLR). The trial was designed to demonstrate non-inferiority (margin of 3.58%) of the Supreme DES at 12 months compared to DP-DES (clinicaltrials.gov-NCT03168776). Results: From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-DES (N=543). At 12 months, TLF occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-DES group (Absolute Risk Difference 0.32%, 95%CI [-1.87%, 2.5%]; p non-inferiority =0.002]. There were no significant differences in rates of device success, clinically driven TLR or stent thrombosis at 12 months, and the safety composite of CV Death and TV MI was 3.5% vs 4.6%; HR [95.0% CI] 0.76 [0.46, 1.25] with Supreme DES compared to DP-DES, though rates of combined clinical and non-clinical driven TLR at 12 months were higher with Supreme DES. Conclusions: Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be non-inferior to the standard DP-DES. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT03168776

scholarly journals Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial

Circulation ◽  
2019 ◽  
Vol 140 (22) ◽  
pp. 1792-1801 ◽  
Author(s):  
Brian A. Bergmark ◽  
Pieter W. Kamphuisen ◽  
Stephen D. Wiviott ◽  
Christian T. Ruff ◽  
Elliott M. Antman ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
At Risk ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Cox Proportional Hazards ◽  
Severe Bleeding ◽  
Bleeding Events ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Relative Safety

Background: Numerous scales exist for the classification of major bleeding events. Limited data compare the most commonly used bleeding scales within a single at-risk cohort of patients with atrial fibrillation. Here, we analyze bleeding outcomes according to the ISTH (International Society on Thrombosis and Hemostasis), TIMI (Thrombolysis in Myocardial Infarction), GUSTO (Global Usage of Strategies to Open Occluded Arteries), and BARC (Bleeding Academic Research Consortium) bleeding scales in the ENGAGE AF (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation)–TIMI 48 trial (NCT00781391) of edoxaban versus warfarin. Methods: A total of 21 105 patients with atrial fibrillation at risk for stroke (CHADS 2 score ≥2) were enrolled in the ENGAGE AF-TIMI 48 trial comparing warfarin with a higher- (60/30 mg daily) or lower- (30/15 mg daily) dose edoxaban regimen. Median follow-up was 2.8 years. Bleeding events occurring among on-treatment patients were examined. Annualized event rates were calculated by the ISTH, TIMI, GUSTO, and BARC scales and compared across treatment arms. Cox proportional hazards for a first bleeding event of each type were calculated for higher-dose edoxaban regimen vs warfarin and lower-dose edoxaban regimen versus warfarin. Results: A total of 10 311 bleeding events were reported. In a comparison of the most severe events in each scale, ISTH major bleeding was the most common (n=1289), followed by TIMI major (n=548), GUSTO severe/life-threatening (n=347), and BARC 3c+5 (n=276) bleeding. Lower bleeding risk with edoxaban compared with warfarin was seen regardless of bleeding scale (higher-dose edoxaban regimen range: hazard ratio [HR], 0.47 [95% CI, 0.35–0.62] for BARC 3c+5 versus HR, 0.80 [95% CI, 0.71–0.91] for ISTH major; lower-dose edoxaban regimen range: HR, 0.32 [95% CI, 0.23–0.45] for BARC 3c+5 versus HR, 0.47 [95% CI, 0.41–0.55] for ISTH major). Furthermore, a gradient of more pronounced risk reduction with edoxaban was observed with greater severity of first bleeding event (higher-dose edoxaban regimen: HR, 0.47 [95% CI, 0.35–0.62] for BARC 3c+5 bleeds versus HR, 0.86 [95% CI, 0.81–0.91] for any BARC bleed; lower-dose edoxaban regimen: HR, 0.32 [95% CI, 0.23–0.45] for BARC 3c+5 bleeds versus HR, 0.68 [95% CI, 0.63–0.72] for any BARC bleed). The direction of this trend was consistent for both gastrointestinal bleeding and nongastrointestinal bleeding. Conclusions: Among patients with atrial fibrillation at risk for stroke, there was a >4-fold difference in the frequency of the most severe bleeding events across commonly used bleeding scales. Furthermore, the relative safety of edoxaban compared with warfarin tended to increase with greater severity of bleeding. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00781391.

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