June-Wha Rhee, MD, cardiologist with specialized clinical and research training in cardiovascular drug toxicity and pharmacogenomics, from Stanford Hospital and Clinics speaks about Impact of Hormonal Therapies for Treatment of Hormone-Dependent Cancers (Breast and Prostate) on the Cardiovascular System: Effects and Modifications.
Link to Abstract:
https://www.ahajournals.org/doi/pdf/10.1161/HCG.0000000000000082
Overview:
The main causes of mortality in the United States are cardiovascular disease and cancer, with hormone-dependent tumors (breast and prostate cancer) being the most frequent noncutaneous malignancies in women and men, respectively. The hormonal (endocrine-related) treatments that are used to treat both malignancies enhance survival rates, but they significantly raise cardiovascular morbidity and death in survivors. This consensus statement outlines the dangers of particular hormone treatments used to treat breast and prostate cancer, as well as an evidence-based strategy for preventing and detecting negative cardiovascular events. The cardiovascular effects of various durations of hormonal therapy, the cardiovascular risks associated with combinations of newer generations of more intensive hormonal treatments, and the specific cardiovascular risks that affect individuals of various races/ethnicities are all highlighted as areas of uncertainty.
Finally, a multidisciplinary approach to the application of lifestyle and pharmaceutical treatments for risk reduction and management is emphasized both during and after active therapy.
June-Wha Rhee, MD, a cardiologist with specialized clinical and research training in cardiovascular drug toxicity and pharmacogenomics, from Stanford Hospital and Clinics speaks about Impact of Hormonal Therapies for Treatment of Hormone-Dependent Cancers (Breast and Prostate) on the Cardiovascular System: Effects and Modifications.
Link to Abstract:
https://www.ahajournals.org/doi/pdf/10.1161/HCG.0000000000000082
Overview:
The main causes of mortality in the United States are cardiovascular disease and cancer, with hormone-dependent tumors (breast and prostate cancer) being the most frequent noncutaneous malignancies in women and men, respectively. The hormonal (endocrine-related) treatments that are used to treat both malignancies enhance survival rates, but they significantly raise cardiovascular morbidity and death in survivors. This consensus statement outlines the dangers of particular hormone treatments used to treat breast and prostate cancer, as well as an evidence-based strategy for preventing and detecting negative cardiovascular events. The cardiovascular effects of various durations of hormonal therapy, the cardiovascular risks associated with combinations of newer generations of more intensive hormonal treatments, and the specific cardiovascular risks that affect individuals of various races/ethnicities are all highlighted as areas of uncertainty.
Finally, a multidisciplinary approach to the application of lifestyle and pharmaceutical treatments for risk reduction and management is emphasized both during and after active therapy.
Dr. Gary F. Marklin is a pulmonologist in Saint Louis, Missouri, and is affiliated with St. Alexius Hospital-Broadway Campus and Mercy Hospital South.
Dr. Marklin has more than 36 years of experience practicing internal medicine and is a seasoned critical care physician. He has worked as a consulting physician at Saint Anthony's Medical Center in the fields of intensive care, respiratory care, and pulmonary care.
Link to Article: https://clinicaltrials.gov/ct2/show/NCT04415658?cond=Cardiac+Death&phase=23&draw=2&rank=24#contacts
Background: Brain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. Intravenous thyroxine is commonly used in donor management. However, small controlled trials have not been able to demonstrate efficacy.
Methods: This multicenter study will involve organ procurement organizations (OPOs) across the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. The primary study hypothesis is that thyroxine treatment results in more hearts transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography.
Discussion: This will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.
Dr. Benjamin Hibbert MD. University of Ottawa Heart Institute - Speaks on Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock
Link to Abstract:
https://www.nejm.org/doi/full/10.1056/NEJMoa2026845?query=cardiology
CONTEXT: Cardiogenic shock is linked to a high rate of morbidity and mortality. Although inotropic support is a common part of medical treatment for cardiogenic shock, there is no data to guide inotropic drug selection in clinical practice.
METHODS: In a double-blind study, individuals with cardiogenic shock were randomly randomized to receive milrinone or dobutamine. In-hospital death from any cause, resuscitated cardiac arrest, cardiac transplantation or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke identified by a neurologist, or beginning of renal replacement therapy were the major outcomes. Individual components of the primary composite result were included as secondary outcomes.
RESULTS: A total of 192 people were enrolled (96 in each group). The primary result did not differ substantially between the treatment groups; 47 participants (49%) in the milrinone group and 52 participants (54%) in the dobutamine group (relative risk, 0.90; 95 percent confidence interval [CI], 0.69 to 1.19; P=0.47) experienced a primary outcome event. Secondary outcomes such as in-hospital death (37 percent and 43 percent of participants, respectively; relative risk, 0.85; 95 percent CI, 0.60 to 1.21), resuscitated cardiac arrest (7 percent and 9 percent; hazard ratio, 0.78; 95 percent CI, 0.29 to 2.07), and mechanical circulatory support (12 percent) showed no significant differences between the groups (22 percent and 17 percent ; hazard ratio, 1.39; 95 percent CI, 0.73 to 2.67).
CONCLUSIONS: There was no significant difference between milrinone and dobutamine in individuals with cardiogenic shock in terms of the key composite outcome or crucial secondary outcomes. (Funded by the Ontario Academic Health Sciences Centres Alternative Funding Plan's Innovation Fund; ClinicalTrials.gov number: NCT03207165. opens in new tab.)
Prof. Elmir Omerovic, MD- Department of Cardiology, Sahlgrenska University Hospital, University of Gothenburg speaks about Long-term mortality in patients with ischaemic heart failure revascularized with coronary artery bypass grafting or percutaneous coronary intervention: insights from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
Link to Abstract:
https://academic.oup.com/eurheartj/article/42/27/2657/6282431
Abstract
Aims:
The goal of this study was to evaluate coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) for the treatment of heart failure caused by ischemic heart disease.
Methods and outcomes:
We looked at all-cause mortality after CABG or PCI in patients with heart failure and multivessel disease (coronary artery stenosis >50 percent in two arteries or the left main) who had coronary angiography in Sweden between 2000 and 2018. To account for known and unknown confounders, we utilized propensity score-adjusted logistic and Cox proportional-hazards regressions, as well as an instrumental variable model. In a hierarchical database, multilevel modeling was employed to account for clustering of observations. There were 2509 patients in all, with 82.9 percent of them being men; 35.8% of them had diabetes, and 34.7 percent had experienced a previous myocardial infarction. The average age was 68.1 9.4 years (47.8% were over 70), and 64.9 percent of the participants had three-vessel or left main illness. PCI was the primary indicated therapy in 56.2 percent of cases, while CABG was the primary designated therapy in 43.8 percent. The median period between follow-ups was 3.9 years (range: 1 day to 10 years). There were a total of 1010 deaths. CABG was associated with a decreased risk of death compared to PCI [odds ratio (OR) 0.62; 95 percent confidence interval (CI) 0.41–0.96; P = 0.031]. Death risk increased linearly with quintiles of hospitals where PCI was the preferred revascularization procedure (OR 1.27, 95 percent CI 1.17–1.38, Ptrend 0.001).
Conclusion:
Long-term survival was higher following CABG than after PCI in patients with ischemic heart failure.
Dr. Gary F. Marklin is a pulmonologist in Saint Louis, Missouri, and is affiliated with St. Alexius Hospital-Broadway Campus and Mercy Hospital South.
Dr. Marklin has more than 36 years of experience practicing internal medicine and is a seasoned critical care physician. He has worked as a consulting physician at Saint Anthony's Medical Center in the fields of intensive care, respiratory care, and pulmonary care.
Link to Article: https://clinicaltrials.gov/ct2/show/NCT04415658?cond=Cardiac+Death&phase=23&draw=2&rank=24#contacts
Background: Brain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. Intravenous thyroxine is commonly used in donor management. However, small controlled trials have not been able to demonstrate efficacy.
Methods: This multicenter study will involve organ procurement organizations (OPOs) across the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. The primary study hypothesis is that thyroxine treatment results in more hearts transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography.
Discussion: This will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.
Prof. Elmir Omerovic, MD- Department of Cardiology, Sahlgrenska University Hospital, University of Gothenburg speaks about Long-term mortality in patients with ischaemic heart failure revascularized with coronary artery bypass grafting or percutaneous coronary intervention: insights from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).
Link to Abstract:
https://academic.oup.com/eurheartj/article/42/27/2657/6282431
Abstract
Aims:
The goal of this study was to evaluate coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) for the treatment of heart failure caused by ischemic heart disease.
Methods and outcomes:
We looked at all-cause mortality after CABG or PCI in patients with heart failure and multivessel disease (coronary artery stenosis >50 percent in two arteries or the left main) who had coronary angiography in Sweden between 2000 and 2018. To account for known and unknown confounders, we utilized propensity score-adjusted logistic and Cox proportional-hazards regressions, as well as an instrumental variable model. In a hierarchical database, multilevel modeling was employed to account for clustering of observations. There were 2509 patients in all, with 82.9 percent of them being men; 35.8% of them had diabetes, and 34.7 percent had experienced a previous myocardial infarction. The average age was 68.1 9.4 years (47.8% were over 70), and 64.9 percent of the participants had three-vessel or left main illness. PCI was the primary indicated therapy in 56.2 percent of cases, while CABG was the primary designated therapy in 43.8 percent. The median period between follow-ups was 3.9 years (range: 1 day to 10 years). There were a total of 1010 deaths. CABG was associated with a decreased risk of death compared to PCI [odds ratio (OR) 0.62; 95 percent confidence interval (CI) 0.41–0.96; P = 0.031]. Death risk increased linearly with quintiles of hospitals where PCI was the preferred revascularization procedure (OR 1.27, 95 percent CI 1.17–1.38, Ptrend 0.001).
Conclusion:
Long-term survival was higher following CABG than after PCI in patients with ischemic heart failure.
Dr. Stefan Anker, MD Charité - From University of Medicine Berlin
Speaks about Empagliflozin in Heart Failure with a Preserved Ejection Fraction.
Link to Abstract:
https://www.nejm.org/doi/full/10.1056/NEJMoa2110956?query=cardiology
BACKGROUND: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has been shown to improve cardiorenal outcomes in patients with stage 3 or 4 chronic kidney disease (CKD) and significant albuminuria, as well as type 2 diabetes. Finerenone's usage in patients with type 2 diabetes and other forms of CKD is unknown.
METHODS:
In this double-blind trial, patients with CKD and type 2 diabetes were randomly randomized to either finerenone or a placebo. Patients with a urinary albumin-to-creatinine ratio of 30 to less than 300 and an estimated glomerular filtration rate (eGFR) of 25 to 90 ml per minute per 1.73 m2 of body surface area (stage 2 to 4 CKD) or a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of at least 60 ml per minute per 1.73 m2 of body surface area (stage 2 to (stage 1 or 2 CKD). Patients were given renin–angiotensin system blockers that had been adjusted to the maximal dose on the manufacturer's label that did not cause unacceptable side effects before randomization. The primary outcome was a composite of mortality from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, as measured by a time-to-event analysis. The first secondary outcome was a composite of kidney failure, a prolonged drop in eGFR of at least 40% from baseline, or death due to renal causes. Adverse occurrences reported by investigators were used to assess safety.
RESULTS:
Randomization was performed on a total of 7437 subjects. During a median follow-up of 3.4 years, a primary outcome event occurred in 458 of 3686 patients (12.4%) in the finerenone group and 519 of 3666 patients (14.2%) in the placebo group (hazard ratio, 0.87; 95 percent confidence interval [CI], 0.76 to 0.98; P=0.03), with the benefit driven primarily by a lower incidence of hospitalization for hepatitis C. (hazard ratio, 0.71; 95 percent CI, 0.56 to 0.90). 350 patients (9.5%) in the finerenone group and 395 (10.8%) in the placebo group experienced the secondary composite result (hazard ratio, 0.87; 95 percent CI, 0.76 to 1.01). There was no significant difference in the overall frequency of adverse events across groups. Finerenone (1.2 percent) had a greater rate of hyperkalemia-related trial regimen discontinuation than placebo (0.8 percent) (0.4 percent ).
CONCLUSIONS:
Finerenone medication improved cardiovascular outcomes in patients with type 2 diabetes and stage 2 to 4 CKD with moderately elevated albuminuria or stage 1 or 2 CKD with severely elevated albuminuria when compared to placebo. (Funded by Bayer; NCT02545049 on ClinicalTrials.gov for FIGARO-DKD. opens in new tab.)
Dr. Benjamin Hibbert MD. University of Ottawa Heart Institute - Speaks on Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock
Link to Abstract:
https://www.nejm.org/doi/full/10.1056/NEJMoa2026845?query=cardiology
CONTEXT: Cardiogenic shock is linked to a high rate of morbidity and mortality. Although inotropic support is a common part of medical treatment for cardiogenic shock, there is no data to guide inotropic drug selection in clinical practice.
METHODS: In a double-blind study, individuals with cardiogenic shock were randomly randomized to receive milrinone or dobutamine. In-hospital death from any cause, resuscitated cardiac arrest, cardiac transplantation or mechanical circulatory support, nonfatal myocardial infarction, transient ischemic attack or stroke identified by a neurologist, or beginning of renal replacement therapy were the major outcomes. Individual components of the primary composite result were included as secondary outcomes.
RESULTS: A total of 192 people were enrolled (96 in each group). The primary result did not differ substantially between the treatment groups; 47 participants (49%) in the milrinone group and 52 participants (54%) in the dobutamine group (relative risk, 0.90; 95 percent confidence interval [CI], 0.69 to 1.19; P=0.47) experienced a primary outcome event. Secondary outcomes such as in-hospital death (37 percent and 43 percent of participants, respectively; relative risk, 0.85; 95 percent CI, 0.60 to 1.21), resuscitated cardiac arrest (7 percent and 9 percent; hazard ratio, 0.78; 95 percent CI, 0.29 to 2.07), and mechanical circulatory support (12 percent) showed no significant differences between the groups (22 percent and 17 percent ; hazard ratio, 1.39; 95 percent CI, 0.73 to 2.67).
CONCLUSIONS: There was no significant difference between milrinone and dobutamine in individuals with cardiogenic shock in terms of the key composite outcome or crucial secondary outcomes. (Funded by the Ontario Academic Health Sciences Centres Alternative Funding Plan's Innovation Fund; ClinicalTrials.gov number: NCT03207165. opens in new tab.)
Dr. Stefan Anker, MD Charité - From University of Medicine Berlin
Speaks about Empagliflozin in Heart Failure with a Preserved Ejection Fraction.
Link to Abstract:
https://www.nejm.org/doi/full/10.1056/NEJMoa2110956?query=cardiology
BACKGROUND: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has been shown to improve cardiorenal outcomes in patients with stage 3 or 4 chronic kidney disease (CKD) and significant albuminuria, as well as type 2 diabetes. Finerenone's usage in patients with type 2 diabetes and other forms of CKD is unknown.
METHODS:
In this double-blind trial, patients with CKD and type 2 diabetes were randomly randomized to either finerenone or a placebo. Patients with a urinary albumin-to-creatinine ratio of 30 to less than 300 and an estimated glomerular filtration rate (eGFR) of 25 to 90 ml per minute per 1.73 m2 of body surface area (stage 2 to 4 CKD) or a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of at least 60 ml per minute per 1.73 m2 of body surface area (stage 2 to (stage 1 or 2 CKD). Patients were given renin–angiotensin system blockers that had been adjusted to the maximal dose on the manufacturer's label that did not cause unacceptable side effects before randomization. The primary outcome was a composite of mortality from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, as measured by a time-to-event analysis. The first secondary outcome was a composite of kidney failure, a prolonged drop in eGFR of at least 40% from baseline, or death due to renal causes. Adverse occurrences reported by investigators were used to assess safety.
RESULTS:
Randomization was performed on a total of 7437 subjects. During a median follow-up of 3.4 years, a primary outcome event occurred in 458 of 3686 patients (12.4%) in the finerenone group and 519 of 3666 patients (14.2%) in the placebo group (hazard ratio, 0.87; 95 percent confidence interval [CI], 0.76 to 0.98; P=0.03), with the benefit driven primarily by a lower incidence of hospitalization for hepatitis C. (hazard ratio, 0.71; 95 percent CI, 0.56 to 0.90). 350 patients (9.5%) in the finerenone group and 395 (10.8%) in the placebo group experienced the secondary composite result (hazard ratio, 0.87; 95 percent CI, 0.76 to 1.01). There was no significant difference in the overall frequency of adverse events across groups. Finerenone (1.2 percent) had a greater rate of hyperkalemia-related trial regimen discontinuation than placebo (0.8 percent) (0.4 percent ).
CONCLUSIONS:
Finerenone medication improved cardiovascular outcomes in patients with type 2 diabetes and stage 2 to 4 CKD with moderately elevated albuminuria or stage 1 or 2 CKD with severely elevated albuminuria when compared to placebo. (Funded by Bayer; NCT02545049 on ClinicalTrials.gov for FIGARO-DKD. opens in new tab.)
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