scholarly journals Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights from the EMPEROR-Reduced Trial

Circulation ◽  
2020 ◽  
Author(s):  
Faiez Zannad ◽  
João Pedro Ferreira ◽  
Stuart J. Pocock ◽  
Cordula Zeller ◽  
Stefan D. Anker ◽  
...  
Keyword(s):  
Kidney Function ◽  
Primary Outcome ◽  
Cardiovascular Death ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Reduced Ejection Fraction ◽  
Secondary Outcomes ◽  
Kidney Impairment ◽  
Kidney Function Decline

Background: In EMPEROR-Reduced, empagliflozin reduced cardiovascular death or HF hospitalization, total HF hospitalizations, and slowed the progressive decline in kidney function in patients with HF and a reduced ejection fraction (HFrEF), with and without diabetes. We aim to study the effect of empagliflozin on cardiovascular and kidney outcomes across the spectrum of kidney function. Methods: In this pre-specified analysis, patients were categorized by the presence or absence of CKD at baseline (eGFR<60ml/min/1.73m 2 or UACR>300mg/g). The primary and key secondary outcomes were (1) a composite of cardiovascular death or HF hospitalization (primary outcome); (2) total HF hospitalizations, and (3) eGFR slope. The direct impact on kidney events was investigated by a prespecified composite kidney outcome (defined as a sustained profound decline in eGFR, chronic dialysis or transplant). The median follow-up was 16 months. Results: 3730 patients were randomized to empagliflozin or placebo, of whom 1978 (53%) had CKD. Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: primary outcome HR=0.78 (95%CI=0.65-0.93) and HR=0.72 (95%CI=0.58-0.90), respectively; interaction P=0.63. Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23-1.98) ml/min/1.73m 2 /year in patients with CKD and by 2.41 (1.49-3.32) ml/min/1.73m2/year in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95%CI=0.31-0.91) and HR=0.46 (95%CI=0.22-0.99), respectively. The effect of empagliflozin on the primary composite outcome and the key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73m 2 . Empagliflozin was well tolerated in CKD patients. Conclusions: In EMPEROR-reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD and regardless of the severity of kidney impairment at baseline. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977

Abstract 16392: The Effect of Dapagliflozin on Anemia in Patients With Heart Failure and Reduced Ejection Fraction: An Analysis of DAPA-HF

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Kieran Docherty ◽  
Silvio E Inzucchi ◽  
Lars Kober ◽  
Mikhail Kosiborod ◽  
Anna Maria Langkilde ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Primary Outcome ◽  
Placebo Treatment ◽  
Cardiovascular Death ◽  
Treatment Allocation ◽  
Reduced Ejection Fraction ◽  
Improved Outcomes ◽  
Patients With Heart Failure

Background: Anemia is common and associated with worse outcomes in patients with heart failure and reduced ejection fraction (HFrEF). We examined: 1) whether dapagliflozin corrected anemia in these patients, and 2) the effect of dapagliflozin on outcomes, in patients with or without anemia, in DAPA-HF. Methods: Anemia was defined as baseline hematocrit <39% in men and <36% in women (WHO). Correction of anemia was defined as two consecutive hematocrit measurements above these thresholds at any time during follow-up (follow-up visits: 2 weeks, 2 and 4 months and 4-monthly thereafter). The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring intravenous therapy) or cardiovascular death. Findings: Of the 4744 patients randomized in DAPA-HF, 4691 had a baseline hematocrit and 1032 were anemic (22.0%). Anemia was corrected in 62% of patients in the dapagliflozin group, compared with 41% of patients in the placebo group (odds ratio 2.37 [95% CI 1.84-3.04]; p<0.001). The effect of dapagliflozin on the primary outcome was consistent in anemic and non-anemic patients (HR 0.68 [95% CI 0.52-0.88] versus 0.76 [0.65-0.89]; P-interaction=0.44) [Figure]. A consistent benefit was also observed for the secondary outcomes, irrespective of anemia status t baseline. Patients with resolution of anemia had better outcomes than those with persisting anemia: rate of primary outcome 9.9 per 100 patient-years (95% CI 8.0-12.4) in those with resolution versus 24.1 per 100 patient-years (20.4-28.3) in those without anemia resolution. Interpretation: Anemia was common in patients in DAPA-HF and associated with worse outcomes. Resolution of anemia was associated with better outcomes than persistence of anemia, regardless of treatment allocation. Although dapagliflozin corrected anemia more often than placebo, treatment with dapagliflozin improved outcomes, irrespective of anemia status.

MO129COMPARATIVE EFFECTIVENESS OF SGLT2I VERSUS DPP4I ON CARDIOVASCULAR AND RENAL OUTCOMES IN ROUTINE-CARE SETTINGS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Edouard Fu ◽  
Marco Trevisan ◽  
Vivekananda Lanka ◽  
Catherine M Clase ◽  
Yang Xu ◽  
...  
Keyword(s):  
Propensity Score ◽  
Kidney Function ◽  
Primary Outcome ◽  
Cox Regression ◽  
Routine Care ◽  
Major Adverse Cardiovascular Events ◽  
All Cause Mortality ◽  
Kidney Function Decline ◽  
Egfr Slope

Abstract Background and Aims While clinical trials have demonstrated the efficacy of SGLT2 inhibitors on preventing cardiovascular and renal damage, few studies have expanded this evidence to routine-care settings. Method We compared clinical outcomes of adults who started SGLT2i or DPP4i therapy in Stockholm, Sweden, during 2013-2019. The primary outcome was a composite of cardiovascular (CV) death and hospitalization for heart failure (HF). Secondary outcomes included major adverse cardiovascular events (MACE; composite of cardiovascular death, myocardial infarction, stroke), all-cause mortality and the rate of eGFR decline (eGFR slope). Propensity score weighted Cox regression was used to balance 55 variables and estimate intention-to-treat hazard ratios with 95% confidence intervals. Differences in eGFR slope were calculated with linear mixed models. Results We identified 7136 individuals starting SGLT2i and 13,618 starting DPP4i therapy. Median age was 64 years (37% women) and median eGFR 86 ml/min/1.73m2. During median follow-up of 2.1 years, 211 individuals developed the primary outcome, 269 experienced MACE and 178 died. After propensity score weighting, patients starting SGLT2i therapy were at lower risk for the composite of CV death/HF hospitalization (HR 0.71; 95% CI 0.53-0.94) compared with DPP4i, and showed a tendency towards lower MACE (0.84; 95% CI 0.67-1.04) and all-cause mortality (0.85; 95% CI 0.62-1.18). There were a median of 4 (interquartile range: 2-8) eGFR measurements during follow-up per patient to estimate their eGFR slopes. In adjusted models, new users of SGLT2i had a slower rate of kidney function decline compared with DPP4i (eGFR slope difference of 0.43 (95% CI 0.15-0.72) ml/min/1.73m2 per year). Results for the primary outcome were consistent across 7 pre-specified subgroups, including eGFR (eGFR ≥60: HR 0.79 [95% CI 0.57-1.08]; eGFR &lt;60: HR 0.62 [0.38-0.99], p-value for interaction 0.40). Conclusion In patients undergoing routine care, initiation of SGLT2i was associated with fewer cardiovascular outcomes and less rapid kidney function decline compared with DPP4i initiation.

scholarly journals Hemoglobin and Clinical Outcomes in the VerICiguaT Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA)

Circulation ◽  
2021 ◽  
Author(s):  
Justin A. Ezekowitz ◽  
Yinggan Zheng ◽  
Alain Cohen-Solal ◽  
Vojtěch Melenovský ◽  
Jorge Escobedo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Outcome ◽  
Cardiovascular Death ◽  
World Health ◽  
Clinical Trial Registration ◽  
Treatment Benefit ◽  
Reduced Ejection Fraction ◽  
Clinical Events ◽  
Patients With Heart Failure ◽  
Health Organization

Background: In the VICTORIA trial, anemia occurred more often in patients treated with vericiguat (7.6%) than placebo (5.7%). We explored the association between vericiguat, randomization hemoglobin, development of anemia and whether the benefit of vericiguat related to baseline hemoglobin. Methods: Anemia was defined as hemoglobin <13.0 g/dL in men and <12.0 g/dL in women (World Health Organization [WHO] Anemia). Adverse events (AEs) reported as anemia were also evaluated. We assessed the risk-adjusted relationship between hemoglobin and hematocrit with the primary outcome (composite of cardiovascular death or heart failure hospitalization), and the time-updated hemoglobin relationship to outcomes. Results: At baseline, 1719 (35.7%) had WHO anemia; median hemoglobin was 13.4 g/L (25th, 75th percentile: 12.1, 14.7 g/dL). At 16 weeks from randomization, 1643 patients had WHO anemia (284 new for vericiguat and 219 for placebo), which occurred more often with vericiguat than placebo (p<0.001). After 16 weeks, no further decline in hemoglobin occurred over 96 weeks of follow-up and the ratio of hemoglobin/hematocrit remained constant. Overall, AE anemia occurred in 342 patients (7.1%). A lower hemoglobin was unrelated to the treatment benefit of vericiguat (vs. placebo) on the primary outcome. Additionally, analysis of time-updated hemoglobin revealed no association with the treatment effect of vericiguat (vs. placebo) on the primary outcome. Conclusions: Anemia was common at randomization and lower hemoglobin was associated with a greater frequency of clinical events. Although vericiguat modestly lowered hemoglobin by 16 weeks, this effect did not further progress nor was it related to the treatment benefit of vericiguat. Clinical Trial Registration: Clinical Trials.gov (NCT02861534)

scholarly journals Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial

2021 ◽  
Vol 14 (6) ◽  
Author(s):  
João Pedro Ferreira ◽  
Zohra Lamiral ◽  
John J.V. McMurray ◽  
Karl Swedberg ◽  
Dirk J. van Veldhuisen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Outcome ◽  
Systolic Heart Failure ◽  
Cardiovascular Death ◽  
Cardiovascular Complications ◽  
Number Needed To Treat ◽  
Unique Identifier ◽  
Cox Models ◽  
Reduced Ejection Fraction ◽  
Patients With Diabetes

Background: Patients with heart failure with reduced ejection fraction (HFrEF) and insulin-treated diabetes have a high risk of cardiovascular complications. Mineralocorticoid receptor antagonists may mitigate this risk. We aim to explore the effect of eplerenone on cardiovascular outcomes and all-cause mortality in HFrEF patients with diabetes, including those treated with insulin in the EMPHASIS-HF trial (Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms). Methods: The primary outcome was the composite of heart failure hospitalization or cardiovascular death. Cox models with treatment-by-diabetes subgroup interaction terms were used. Results: The median follow-up was 21 (10–33) months. Of the 2737 patients included, 623 (23%) had non-insulin-treated diabetes, 236 (9%) had insulin-treated diabetes and 1878 did not have diabetes. Patients with insulin-treated diabetes were younger, more often women, with higher body mass index, waist circumference, more frequent ischemic heart failure cause, impaired kidney function, and longer diabetes duration. Compared with patients without diabetes, those with insulin-treated diabetes had a 2-fold higher risk of having a primary outcome event. The hazard ratio (95% CI) for the effect of eplerenone, compared with placebo, on the primary outcome was 0.31 (0.19–0.50) in insulin-treated diabetes, 0.69 (0.50–0.93) in non-insulin-treated diabetes, and 0.72 (0.58–0.88) in patients without diabetes; interaction P =0.007. The annualized number needed-to-treat-to-benefit with regards to the primary outcome was 3 (95% CI, 3–4) in patients with insulin-treated diabetes, 16 (13–19) in patients with diabetes not receiving insulin, and 26 (24–28) in patients without diabetes. Conclusions: Patients with insulin-treated diabetes experienced a greater benefit from eplerenone than those with diabetes not treated with insulin and people without diabetes. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00232180.

Kidney function decline is associated with an accelerated increase in plasma homocysteine in older adults: a longitudinal study

2021 ◽  
pp. 1-21
Author(s):  
Hui Zhang ◽  
Yi Li ◽  
Meng Hao ◽  
Xiaoyan Jiang ◽  
Jiucun Wang ◽  
...  
Keyword(s):  
Kidney Function ◽  
Repeated Measurements ◽  
Baseline Survey ◽  
Mixed Effect ◽  
Pronounced Increase ◽  
Crude Model ◽  
The Mean ◽  
Kidney Function Decline ◽  
Over Time

Abstract Background: Few studies have been conducted to investigate the association of kidney function decline with the trajectories of homocysteine (Hcy) over time, using repeated measurements. We aimed to investigate the association of kidney function with changes in plasma Hcy levels over time. Methods: Data were collected from the Rugao Longevity and Ageing Study. In detail, plasma Hcy and creatinine levels were measured in both waves (waves 2, 3 and 4) during the 3.5-year follow-up (N = 1135). Wave 2 was regarded as the baseline survey. The estimated glomerular filtration rate (eGFR) was calculated based on creatinine. Subjects were categorized into four groups according to quartiles of eGFR at baseline. Linear mixed-effect models were used to investigate the association of eGFR with subsequent plasma Hcy levels. Results: The mean eGFR at baseline was 90.84 (11.42) mL/min/1.73 m2. The mean plasma Hcy level was 14.09 (6.82) at baseline and increased to 16.28 (8.27) and 17.36 (10.39) μmol/L during follow-ups. In the crude model, the interaction between time and eGFR at baseline was significant (β = −0.02, 95% CI: −0.02 to −0.01, p = 0.002). After adjusting for confounding factors, a significant relationship remained (β = −0.02, 95% CI: −0.02 to −0.01, p = 0.003), suggesting that kidney function decline at baseline was associated with a faster increase in Hcy levels. Conclusion: Kidney function decline is associated with a more pronounced increase in plasma Hcy levels. Further studies with longer follow-up periods and larger sample sizes are needed to validate our findings.

Efficacy of intravitreal conbercept injection in the treatment of retinopathy of prematurity

2018 ◽  
Vol 103 (4) ◽  
pp. 494-498 ◽  
Author(s):  
Yichen Bai ◽  
Huanjie Nie ◽  
Shiyu Wei ◽  
Xiaohe Lu ◽  
Xiaoyun Ke ◽  
...  
Keyword(s):  
Retinopathy Of Prematurity ◽  
Laser Photocoagulation ◽  
Primary Outcome ◽  
Safety And Efficacy ◽  
Postmenstrual Age ◽  
Zone Ii ◽  
The Mean ◽  
Secondary Outcomes ◽  
Number Of Injections

BackgroundTo evaluate the safety and efficacy of intravitreal conbercept (IVC) injection in the treatment of retinopathy of prematurity (ROP).MethodsPatients with ROP who underwent IVC injection in Zhujiang Hospital from June 2015 to July 2016 were studied retrospectively. The primary outcome was defined as the regression of plus disease. The secondary outcomes were defined as the presence of recurrence, number of injections and the final regression of disease.ResultsA total of 48 eyes of 24 patients with ROP were included. Among them, 9 eyes of 5 patients had zone I ROP, 35 eyes of 18 patients had zone II ROP and 4 eyes of 2 patients had aggressive posterior ROP. The mean gestational age was 28.5±1.6 weeks, the mean birth weight was 1209.6±228.6 g, the mean postmenstrual age of first injection was 34.2±1.9 weeks and the mean follow-up period was 31.0±4.7 weeks. Forty of 48 eyes (83.3%) received IVC only once, and the regression of plus disease occurred at an average of 3.5±1.5 weeks after the first injection of conbercept. For eight recurrent eyes (16.7%), four eyes received a second IVC and the remaining four eyes received laser photocoagulation, and the regression of plus disease occurred in 3 weeks. No lens opacity, vitreous haemorrhage, entophthalmia or retinal detachment was observed during follow-up.ConclusionIVC injection is an effective treatment for ROP.

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 A Virtual Reality-Based Self-Help Intervention for Dealing with the Psychological Distress Associated with the COVID-19 Lockdown: An Effectiveness Study with a Two-Week Follow-Up

2021 ◽  
Vol 18 (15) ◽  
pp. 8188
Author(s):  
Giuseppe Riva ◽  
Luca Bernardelli ◽  
Gianluca Castelnuovo ◽  
Daniele Di Lernia ◽  
Cosimo Tuena ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Psychological Distress ◽  
Outcome Measures ◽  
Perceived Stress ◽  
Social Connectedness ◽  
Primary Outcome ◽  
Post Intervention ◽  
Stress Levels ◽  
Secondary Outcomes

The aim of this study is to investigate the effectiveness of a novel self-administered at-home daily virtual reality (VR)-based intervention (COVID Feel Good) for reducing the psychological burden experienced during the COVID-19 lockdown in Italy. A total of 40 individuals who had experienced at least two months of strict social distancing measures followed COVID Feel Good between June and July 2020 for one week. Primary outcome measures were depression, anxiety, and stress symptoms, perceived stress levels, and hopelessness. Secondary outcomes were the experienced social connectedness and the level of fear experienced during the COVID-19 pandemic. Linear mixed-effects models were fitted to evaluate the effectiveness of the intervention. Additionally, we also performed a clinical change analysis on primary outcome measures. As concerning primary outcome measures, participants exhibited improvements from baseline to post-intervention for depression levels, stress levels, general distress, and perceived stress (all p < 0.05) but not for the perceived hopelessness (p = 0.110). Results for the secondary outcomes indicated an increase in social connectedness from T0 to T1 (p = 0.033) but not a significant reduction in the perceived fear of coronavirus (p = 0.412). Among these study variables, these significant improvements were maintained from post-intervention to the 2-week follow-up (p > 0.05). Results indicated that the intervention was associated with good clinical outcomes, low-to-no risks for the treatment, and no adverse effects or risks. Globally, evidence suggests a beneficial effect of the proposed protocol and its current availability in 12 different languages makes COVID Feel Good a free choice for helping individuals worldwide to cope with the psychological distress associated with the COVID-19 crisis, although large scale trials are needed to evaluate its efficacy.

scholarly journals Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services

2020 ◽  
Vol 77 (7) ◽  
pp. 454-461 ◽  
Author(s):  
Marijke Keus van de Poll ◽  
Lotta Nybergh ◽  
Caroline Lornudd ◽  
Jan Hagberg ◽  
Lennart Bodin ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Mental Disorders ◽  
Occupational Health ◽  
Sickness Absence ◽  
Primary Outcome ◽  
Common Mental Disorders ◽  
Significant Group ◽  
Secondary Outcomes

ObjectivesCommon mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.MethodsRandomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee’s manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.ResultsA statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.ConclusionPSI was effective in reducing sickness absence which was the primary outcome in this study.

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.

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