Month: November 2018
New TAVR Insights: Survival Advantage of TAVR Over SAVR Not Sustained At Five Years, Severe Prosthesis-Patient Mismatch Not Benign Following TAVR
The 5-year outcomes of a trial conducted by Gleason et al. published in JACC demonstrated a similar safety profile, functional recovery, and freedom from severe structural valve deterioration (SVD) for both TAVR and SAVR, consistent with earlier-term reports. These outcomes supported TAVR as a reasonable alternative to SAVR in the high-risk population and its current Class I indication. Continue reading
Coronary Physiology Beyond Coronary Flow Reserve: A Giant Leap in the Understanding of Coronary Microvascular Disease A JACC State-of-the-Art Review
In a JACC State-of-the-Art Review by Dr. Lance Gould and his colleagues at UTHealth, Houston, Texas, the pathophysiology of Coronary microvascular disease (CMD) was summarized and an update was provided of diagnostic testing strategies, and classification of CMD into phenotypes according to severity and coexistence with atherosclerosis. Moreover, emerging data highlighting the significance of CMD in specific populations, including obesity and insulin resistance, myocardial injury and heart failure with preserved ejection fraction, and nonobstructive and obstructive coronary artery disease were analyzed. Lastly, the role of CMD as a potential target for novel interventions beyond conventional approaches, representing a new frontier in cardiovascular disease reduction was explored. Continue reading
NT-ProBNP-Guided Medical Therapy Failed To Show Superiority Compared To Usual Care In HFrEF Results from the GUIDE-IT trial
Results of a multi-center, randomized clinical trial which enrolled 894 patients with heart failure (HF) with reduced ejection fraction (EF ≤40%) published in the most recent issue of the Journal of the American College of Cardiology (JACC) have shown that management, using NT-ProBNP-guided optimal medical therapy, has higher total costs and fails to show superior efficacy in improving quality of life (QoL) outcomes compared to usual care (titration of guideline-recommended therapy to doses established in pivotal clinical trials).
The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial planned to prospectively enroll 1100 patients from 45 clinical sites in the United States and Canada. After a scheduled review by the DSMB, the study was stopped for lack of efficacy of the biomarker-guided strategy. The patients included in the study presented with chronic HF and an EF of ≤40%; these subjects were randomly assigned in a 1:1 fashion to an NT-proBNP-guided treatment strategy (n=446) or usual care (n=448). Patients in the NT-proBNP- guided strategy received medical therapy with a goal of achieving a NT-proBNP level <1000 pg/ml. Structured evaluations performed at baseline and 3, 6, 12, and 24 months post-randomization were employed to collect and compare data on quality of life (QoL). The Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and the Duke Activity Status Index (DASI) were used to stratify pre-specified QoL measures. In addition, researchers examined the costs associated with either treatment strategy in 735 US patients. The results showed that both the KCCQ and the DASI improved over the first 6 months ( 11-point improvement in the 4 KCCQ composite scales which included physical limitations, total symptoms, QoL, and social limitations), but no evidence was found for a strategy-related difference (mean difference [biomarker-guided usual care] at 24 months of follow-up, 2.0 for DASI [95% confidence interval (CI): 1.3 to 5.3] and 1.1 for KCCQ [95% CI: 3.7 to 5.9]). Albeit the lack of strategy-related difference, both treatment arms did show improvements in KCCQ and DASI scores overall. Total winsorized costs (to reduce the effect of possibly false outliers) averaged $5,919 higher in the biomarker-guided strategy (95% CI: $1,795 + $13,602) over 15-month median follow-up.
“The big message from GUIDE-IT, or a big message from GUIDE-IT, is that, regardless of which arm you ran patients on or who got treated more aggressively, when we were able to get their NT-proBNP levels down, the lower did better regardless of which treatment arm they were in.” – G. Michael Felker, MD, MHS (Duke University Medical Center)
Previous trials have revealed various effective management strategies for HF patients that lead to symptomatic relief (primarily dyspnea) and improve prognosis but other major symptoms such as fatigue and exercise intolerance have not been well correlated with either central measures of cardiac performance or measures of patient-reported QoL. Indeed, most of the clinical trials of effective medical therapies in HF that included QoL measurement showed small or no changes in QoL. NT‐proBNP has emerged as a powerful biomarker in various cardiovascular diseases and serves to provide strong and independent prognostic information in patients with heart failure. The investigators of the GUIDE-IT trial aimed to study whether the attempt to achieve a sufficiently low NT-proBNP level would affect QoL either beneficially or adversely. The investigators concluded that they found no evidence of a QoL effect associated with randomization to the strategy of NT-proBNP– guided therapy. In 735 patients enrolled in the United States, medical costs were increased in the biomarker-guided arm, primarily due to extra hospital-based care.
The limitations of the study included early termination with less follow-up time than was planned for in the trial design, secondly the unblinded nature of the analyses may have contributed to the lack of benefit seen in the biomarker-guided arm. Thirdly, both groups had more frequent medical contacts related to study participation compared to standard of care.
Diagnosis of Frailty in a Patient with Acute Myocardial Infarction Helps Personalize an Approach to Optimize Outcomes The Association of Frailty With In-Hospital Bleeding Among Older Adults With Acute Myocardial Infarction: Insights From the ACTION Registry
In a report in this issue of the JACC: Cardiovascular Interventions, Dr. John A Dodson and his colleagues from the New York University School of Medicine reported that frail patients had lower use of cardiac catheterization and higher risk of major bleeding (when catheterization was performed) as compared to non-frail patients, thereby drawing attention to clinical strategies to avoid bleeding imperative in this population. Continue reading
N- acetylcysteine and Intravenous Sodium Bicarbonate Infusion in the Prevention of Contrast Associated Kidney Injury: A Cautionary Tale Strategies to Reduce Acute Kidney Injury and Improve Clinical Outcomes Following Percutaneous Coronary Intervention: A Subgroup Analysis of the PRESERVE Trial
A study published in JACC Cardiovascular Interventions has shown that among patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI), there was no benefit of IV sodium bicarbonate over IV sodium chloride or of acetylcysteine over placebo for the prevention of contrast-associated acute kidney injury (CAAKI) or intermediate-term adverse outcomes. Continue reading
Workplace Bullying and Violence Might be New, Potentially Modifiable Cardiovascular Risk Factors A multi-cohort study
A European study has revealed that bullying and violence are common at workplaces and those exposed to such stressors are at higher risk of cardiovascular disease (CVD). Psychosocial cardiovascular risk factors such as depression, subclinical depressive symptoms, vital exhaustion, anger, and personality traits such as hostility have been demonstrated as independent predictors of incident cardiovascular disease (CVD). Additionally, social factors associated with increased CVD risk include low socio-economic status, social isolation, low social support, and stress at work or in family life. Psychological and social factors are strongly inter-related and tend to cluster in certain individuals. In the recent most issue of the European Heart Journal, Xu et al. aimed to provide evidence for yet another psychosocial factor involved in CVD risk. Continue reading
Mechanistic Study Delves Into Heart Failure Benefits Noted With Empagliflozin EMPA-HEART Cardiolink-6 - EMPA-HEART
The EMPA-HEART trial showed that empagliflozin resulted in beneficial effects on left ventricular remodeling at 6 months among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD) but normal ejection fraction and without a clear heart failure history. The findings were presented by Dr. Subodh Verma at the American Heart Association Annual Scientific Sessions (AHA 2018) in Chicago, Illinois. Continue reading
TRED-HF: Tread With Caution While Withdrawing Heart Failure Medication in Recovered Dilated Cardiomyopathy Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy: an open-label, pilot, randomised trial
The results of the TRED-HF trial published in The Lancet showed that withdrawal of heart failure medications among patients with dilated cardiomyopathy (DCM) who had recovered their LV function resulted in the relapse of HF. According to Halliday and his colleagues, until robust predictors of relapse are defined, treatment should continue indefinitely. Continue reading
Does Low Dose Methotrexate Prevent Athersclerotic Events in Patients?
A randomized clinical trial that was conducted by Paul M Ridker et al. and published in NEJM showed that there was no meaningful association between low dose methotrexate (MTX) administration and a decrease in cardiovascular events. Additionally, MTX usage was associated with adverse effects. Continue reading
Canakinumab: A New Hope for Post MI Patients with Increased hsCRP in the Prevention of Heart Failure The exploratory analysis of the CANTOS trial showed that canakinumab can decrease hear failure hospitalizations in ischemic patients in a dose-dependent manner
Canakinumab (an IL-B inhibitor) is associated with decreased heart failure (HF) hospitalizations and the composite of heart failure hospitalization and heart-failure related mortality in patients with a history of myocardial infarction (MI) and elevated high-sensitivity C-reactive protein (hsCRP), according to a new study published in Circulation. Continue reading
Superior Efficacy of Sacubitril-Valsartan Compared to Enalapril for lowering NT Pro-BNP in Patients Hospitalized for HFrEF Pioneering a new strategy for managing acute decompensation in HFrEF (Results from the PIONEER-HF trial)
Results from a multi-center, randomized, double-blind, double dummy, parallel group clinical trial which enrolled 881 patients with heart failure (HF) with reduced ejection fraction (HFrEF-left ventricular ejection fraction of 40% or less) have shown superior efficacy of Sacubitril–Valsartan combination (Entresto; Novartis) in reducing N-terminal pro-B-type natriuretic peptide compared to Enalapril alone. The patients were hospitalized for acute decompensation of HF, and treatment with Sacubitril–Valsartan achieved a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations without any significant offsetting serious adverse events. Findings from the trial were presented at the 2018 AHA Scientific Session and simultaneously published in the New England Journal of Medicine (NEJM). Continue reading
Dapaglifozin ‘DECLARED’ Effective in the Reduction of Heart Failure Hospitalizations in Diabetic Population DECLARE-TIMI 58: Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes
The DECLARE–TIMI 58 trial, published in the New England Journal of Medicine and presented at AHA 2018 showed that in patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin was non-inferior for reduction of MACE as compared to placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure. Continue reading
Saphenous Vein Graft Harvesting for CABG: Endoscopic Vs Open Technique Results from the REGROUP trial
A new study published in the New England Journal of Medicine showed no significant difference in the risk of major adverse cardiac events (MACE) between patients undergoing endoscopic and open harvest of the saphenous vein grafts for coronary artery bypass grafting (CABG). Continue reading
Fish Oil or Vitamin D Supplementation as Protection Against Cardiovascular Events or Cancer Suffers Deteriorating ‘VITAL’ Signs AHA 2018: Vitamin D and Omega-3 Trial (VITAL)
The VITAL trial conducted by Manson et al. showed that supplementation with either n–3 fatty acids at a dose of 1 g/day or vitamin D3 at a dose of 2000 IU/day was not effective for primary prevention of cardiovascular or cancer events among healthy middle-aged men and women over 5 years of follow-up. The results were reported on Saturday at the American Heart Association Scientific Sessions meeting in Chicago and online in the New England Journal of Medicine. Continue reading
Inducible Myocardial Ischemia May Be Excluded by Low Levels of High Sensitivity Cardiac Troponin Levels
In an original cohort study by Hammadah et al recently published in Annals of Internal Medicine, it has been found that very low high-sensitivity cardiac troponin(hs-cTn) levels can be used in the exclusion of inducible myocardial ischemia in patients with stable coronary artery disease (CAD). Moreover, it identifies people with CAD who have a lower risk of ischemia during stress testing and adverse cardiovascular events. Continue reading
The Latest Incarnation of the Blood Cholesterol Management Guideline 2018: Numbers Matter, Lower LDL-C is better A Special Report From the American Heart Association and American College of Cardiology
The AHA/ACC 2018 guideline on the management of blood cholesterol, endorsed by at least 10 other medical societies, was published online in the Journal of the American College of Cardiology and in Circulation to coincide with its grand unveiling at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, Illinois. Continue reading
Type 2 Diabetes: SGLT2 Inhibitors Demonstrate Robust Benefits on Cardiovascular and Renal Outcomes SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials
The results of a study presented at AHA 2018 have shown that SGLT2 inhibitors (SGLT2i ) have robust benefits on the reduction of hospitalization for heart failure (HF) and progression of renal disease regardless of existing atherosclerotic cardiovascular disease (ASCVD) or a history of HF. The findings were published online in The Lancet. Continue reading
Fish Oil Use in Hypertriglyceridemia Reduces Risk of Ischemic Events, Over-The-Counter Fish Oil Supplements Still ‘Fishy’ Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia
A study by Bhatt et al. published online in the New England Journal of Medicine, accompanied by a detailed supplement, was presented at AHA 2018 in Chicago, Illinois. The study demonstrated that among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly reduced among those who received 2 g of icosapent ethyl twice daily as compared with patients who received placebo. Continue reading
Endogenous Fibrinolysis Measurement as a Predictive Test for Recurrent Cardiovascular Events Impaired endogenous fibrinolysis in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention is a predictor of recurrent cardiovascular events: the RISK PPCI study.
A prospective cohort study that was conducted by Mohamed Farag et al. in European Heart Journal demonstrated that evaluating endogenous fibrinolysis in patients with acute coronary syndrome may help physicians identify high-risk patients developing recurrent cardiovascular events, especially among those treated with dual antiplatelet therapy (DAT) after primary percutaneous coronary intervention (PPCI). Continue reading
Does a Low Salt Diet Improve Heart Failure Prognosis? Reduced Salt Intake for Heart Failure: A Systematic Review
A systematic review conducted by Kamal R. Mahtani et al in JAMA looked into the evidence of salt restriction recommendation on heart failure prognosis. The investigators evaluated previous trials but could not find a conclusive relationship between salt consumption and heart failure prognosis. Continue reading