The findings of a randomized, controlled, open-label trial conducted by Dr. Hyuk-Jae Chang, Division of Cardiology, Severance Cardiovascular Hospital, Seoul, South Korea and his colleagues, has reported that in stable patients with suspected coronary artery disease (CAD) who are eligible for invasive coronary angiography (ICA), the comparable 1-year major adverse cardiovascular events rates following a selective referral and direct referral strategy were suggestive that both diagnostic approaches were similarly effective. Moreover, in the selective referral strategy, the reduced use of ICA was associated with a greater diagnostic yield, which supported the usefulness of coronary computed tomographic angiography (CCTA) as an efficient and accurate method to guide decisions of ICA performance. The findings were published online in JACC: Cardiovascular Imaging. Continue reading →

Parachute use on jumping from an aircraft does not reduce death or major traumatic injuries when compared with jumping with empty backpacks, according to a new trial published in the British Medical Journal. Continue reading →

A study conducted by Yongle Xu et al. demonstrated that the superiority of Drug-Coated Balloon (DCB) versus percutaneous transluminal angioplasty (PTA) in the efficacy of femoropopliteal artery disease (FPAD) treatment persists at 24-month follow-up. The findings, which were published online in JACC: Cardiovascular Interventions, also showed that the safety of DCB was equivalent to that of PTA. Continue reading →

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 →

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.

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.

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 →

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 →

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 →

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 →

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 →

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 →

 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 →

The use of Proton Pump Inhibitors (PPIs) for prophylaxis against gastrointestinal (GI) bleeding due to stress ulceration in critically ill patients admitted to the Intensive Care Unit (ICU) was not associated with improved mortality rate or fewer clinically important events, according to a new study published in the New England Journal of Medicine. Continue reading →

The results of the recently published Harmony-Outcomes study in The Lancet, led by Professor Stefano Del Prato, University of Pisa, Italy and Professor John McMurray, University of Glasgow, UK, have demonstrated that among patients with concomitant type 2 diabetes and cardiovascular disease, albiglutide, a glucagon-like peptide 1 receptor agonist is superior to placebo in the reduction of major adverse cardiovascular events. The study suggests that evidence-based glucagon-like peptide 1 receptor agonists should be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Continue reading →

An observational cross-sectional cohort study by Amin et al. suggested that greater and more consistent use of same-day discharge(SDD) following elective percutaneous coronary intervention (PCI) is the United States, could markedly increase the overall value of PCI care. Apparently, SDD was not only safe but associated with large savings of more than $5000 per PCI. Continue reading →

Results from the Portico 1 study were presented during a late-breaking session at the Transcatheter Cardiovascular Therapeutics conference in San Diego showing that transcatheter aortic valve replacement (TAVR) with the new transcatheter heart valve (THV) in patients at increased surgical risk is associated with low 1-year mortality and stroke rates. In the study, favorable hemodynamic results at 1 year were observed with low transvalvular pressure gradient and incidence of significant Paravalvular leakage (PVL).   The results were also published online in the Journal of American College of Cardiology. Continue reading →

The findings of the Pulmonary artery denervation (PADN) trial, presented at the TCT conference on Sept 23rd have shown that PADN is associated with significant improvements in hemodynamic and clinical outcomes including 6-minute walk distance (6MWD) and pulmonary vascular resistance (PVR) in patients with combined pre- and post-capillary pulmonary hypertension CpcPH. The results of this study were simultaneously published in JACC: Interventions. Continue reading →

For angina patients without obstructive coronary artery disease (CAD), adjunctive testing of coronary vascular function during coronary angiography followed by medical therapy targeted to the findings improved angina outcomes, according to the CorMicA trial. In the study published in the Journal of the American College of Cardiology, a tiered approach for assessment for microvascular and/or vasospastic angina among patients with stable angina and no evidence of significant epicardial disease was deemed superior to usual care. Continue reading →

The results of PREPARE-CALC trial, presented at TCT 2018, have shown that among patients with severely calcified coronary lesions, the routine use of upfront high-speed rotational atherectomy (RA) increases stent deliverability compared with the use of balloon modification techniques such as scoring or cutting balloons (MB), with similar rates of angiographic late lumen loss and other clinical outcomes at 9 months. In his presentation in San Diego, the author, Dr. Gert Richardt emphasized that a strategy of provisional MB remained feasible, safe, and effective as long as bailout RA was readily available and offered the advantages of compatibility with smaller sized catheters and less irradiation. Continue reading →

In the long saga of ABSORB trials, the ABSORB IV trial presented at the TCT conference 2018 showed that polymeric coronary bioresorbable vascular scaffolds (BVS) were non-inferior to cobalt-chromium-based Xience DES for cardiovascular outcomes of target lesion failure and angina in fairly simple lesion types, with lower acute procedural success in a 1 year period. The results for this trial were published today in The Lancet. Continue reading →