2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Hicks, Karen A.; Mahaffey, Kenneth W.; Mehran, Roxana; Nissen, Steven E.; Wiviott, Stephen D.; Dunn, Billy; Solomon, Scott D.; Marler, John R.; Teerlink, John R.; Farb, Andrew; Morrow, David A.; Targum, Shari L.; Sila, Cathy A.; Hai, Mary T. Thanh; Jaff, Michael R.; Joffe, Hylton V.; Cutlip, Donald E.; Desai, Akshay S.; Lewis, Eldrin F.; Gibson, C. Michael; Landray, Martin J; Lincoff, A. Michael; White, Christopher J.; Brooks, Steven S.; Rosenfield, Kenneth; Domanski, Michael J.; Lansky, Alexandra J.; McMurray, John J.V.; Tcheng, James E.; Steinhubl, Steven R.; Burton, Paul; Mauri, Laura; O’Connor, Christopher M.; Pfeffer, Marc A.; Hung, H. M. James; Stockbridge, Norman; Chaitman, Bernard R.; Temple, Robert; Fitter, Heather D.; Illoh, Kachikwu; Cavanaugh, Kenneth J.; Scirica, Benjamin M.; Irony, Ilan; Kichline, Rachel E. Brown; Levine, Jonathan G.; Park, Anna; Sacks, Leonard; Szarfman, Ana; Unger, Ellis F.; Wachter, Lori Ann; Zuckerman, Bram; Mitchel, Yale; Peddicord, Douglas; Shook, Thomas; Kisler, Bron; Jaffe, Charles L.; Bartley, Rhonda; DeMets, David L.; Mencini, MariJo; Janning, Cheri; Bai, Steve; Lawrence, John; D’Agostino, Ralph B.; Pocock, Stuart J.

doi:10.1016/j.jacc.2017.12.048

Cited by 265 publications

(192 citation statements)

References 26 publications

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“…Consequently, the number of patients and exposure times in this study were low, as were the number of adjudicated MACE. The adjudication process changed in November 2013 from consensus‐based to blinded independent review, and there were also changes in the individuals conducting adjudication as well as changes from committee‐created definitions of events to Food and Drug Administration−approved definitions . These procedural changes may have introduced variables into the adjudication outputs.…”

Section: Discussionmentioning

confidence: 99%

Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

Charles‐Schoeman

DeMasi

Valdez

et al. 2019

Arthritis & Rheumatology

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Objective Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). This study was undertaken to evaluate the risk of major adverse cardiovascular events (MACE) in patients with RA receiving tofacitinib. Methods Data were pooled from patients with moderately to severely active RA receiving ≥1 tofacitinib dose in 6 phase III and 2 long‐term extension studies over 7 years. MACE (myocardial infarction, stroke, cardiovascular death) were independently adjudicated. Cox regression models were used to evaluate associations between baseline variables and time to first MACE. Following 24 weeks of tofacitinib, changes in variables and time to future MACE were evaluated after adjusment for age, baseline values, and time‐varying tofacitinib dose. Hazard ratios and 95% confidence intervals were calculated. Results Fifty‐two MACE occurred in 4,076 patients over 12,873 patient‐years of exposure (incidence rate 0.4 patients with events per 100 patient‐years). In univariable analyses of baseline variables, traditional cardiovascular risk factors and glucocorticoid and statin use were associated with MACE risk; disease activity and inflammation measures were not. In subsequent multivariable analyses, baseline age, hypertension, and the total cholesterol to high‐density lipoprotein (HDL) cholesterol ratio remained significantly associated with risk of MACE. After 24 weeks of treatment, an increase in HDL cholesterol and a decrease in the total to HDL cholesterol were associated with decreased MACE risk; changes in total cholesterol, low‐density lipoprotein (LDL) cholesterol, and disease activity measures were not. Increased erythrocyte sedimentation rates trended with increased future MACE risk. Conclusion In this post hoc analysis, after 24 weeks of tofacitinib treatment, increased HDL cholesterol, but not increased LDL cholesterol or total cholesterol, appeared to be associated with lower future MACE risk. Further data are needed to test the cardiovascular safety of tofacitinib.

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Section: Discussionmentioning

confidence: 99%

Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

Charles‐Schoeman

DeMasi

Valdez

et al. 2019

Arthritis & Rheumatology

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“…The variables reported include demographic data, patients’ previous medical history, and diagnoses at admission. Mortality causes were classified according to the definitions of the Standardized Data Collection for CV Trials Initiative (SCTI) and the US Food and Drug Administration [13]. …”

Section: Methodsmentioning

confidence: 99%

Seasonality in Mortality in a Cardiology Department: A Five-Year Analysis in 500 Patients

et al. 2019

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Background: Previous studies have indicated that cardiovascular mortality follows a seasonal trend. The aim of this work was to determine the evolution of mortality throughout the year in a cardiology department. Methods: All admissions and deaths occurring in our Cardiology Department over a 5-year period (2013–2017) were recorded retrospectively. Results: From a total of 17,829 hospital admissions, 500 patients died (2.8%, 0.3 patients/day). The mean age of deceased patients was 74.2 ± 13.1 years, and 186 (37.2%) were women. Mortality ranged from 0.17 deaths/day in August to 0.40 deaths/day in February (p = 0.03), and from 0.20 deaths/day in summer to 0.36 deaths/day in winter (p = 0.001). There was also a trend towards a variation in hospitalizations, with a peak in January (10.5 admissions/day) and the lowest figure in August (7.0 admissions/day), p = 0.047. We found no significant seasonal trend regarding mortality rate with respect to the number of hospital admissions (p = 0.89). The most common cause of death was refractory heart failure (267 patients [65.8%]). A noncardiac cause of death was observed in 134 patients (26.8%). Conclusions: In a cardiology department, there are twice as many deaths in winter as in summer. Hospitalizations also tend to be more frequent in winter than in summer.

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“…observational vs. randomized clinical trial, should be used . For diagnostic studies, the reference standard should be clearly described and for prognostic studies, authors should report how the primary outcome was adjudicated, as applicable . A description of the key aspects of both the general study design and LUS‐specific components is provided in the reporting checklist ( Table and Figure ).…”

Section: Reporting Checklistmentioning

confidence: 99%

Expert consensus document: Reporting checklist for quantification of pulmonary congestion by lung ultrasound in heart failure

Platz

Jhund

Girerd

et al. 2019

European J of Heart Fail

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108

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Lung ultrasound is a useful tool for the assessment of patients with both acute and chronic heart failure, but the use of different image acquisition methods, inconsistent reporting of the technique employed and variable quantification of 'B-lines,' have all made it difficult to compare published reports. We therefore need to ensure that future studies utilizing lung ultrasound in the assessment of heart failure adopt a standardized approach to reporting the quantification of pulmonary congestion. Strategies to improve patient care by use of lung ultrasound in the assessment of heart failure have been difficult to develop. In the present document, key aspects of standardization are discussed, including equipment used, number of chest zones assessed, the method of quantifying B-lines, the presence and timing of additional investigations (e.g. natriuretic peptides and echocardiography) and the impact of therapy. This consensus report includes a checklist to provide standardization in the preparation, review and analysis of manuscripts. This will serve as a guide for investigators and clinicians and enhance the quality and transparency of lung ultrasound research.

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2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Cited by 265 publications

References 26 publications

Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

Seasonality in Mortality in a Cardiology Department: A Five-Year Analysis in 500 Patients

Expert consensus document: Reporting checklist for quantification of pulmonary congestion by lung ultrasound in heart failure

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