A study by Dr. Jeffrey Popma and colleagues published in the New England Journal of Medicine showed that transcatheter aortic-valve replacement (TAVR) was non-inferior to surgery with respect to death or the occurrence of a disabling stroke by 24 months in the low-risk group of patients with aortic stenosis. Previous studies showed that in patients with severe aortic stenosis who were at high risk of complications or death from surgery, TAVR with a self-expanding supra-annular bioprosthesis had better outcomes than medical therapy or surgery. However, there was not enough evidence to advocate the use of TAVR instead of surgery in a younger, healthier population. The authors aimed to address this knowledge gap through this study.

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A randomized, mutilcenter, placebo-controlled, phase 3 clinical trial which enrolled 676 patients (aged 18-80 years) presenting to the ER with acute ischemic stroke assessed  the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to intravenous tissue plasminogen activator (IV-tPA, administered over 60 minutes) treatment (CLOTBUST-ER trial). The results from the trial, which was stopped due to futility show that although the use of sonothrombolysis was feasible and most likely safe, no clinical benefit was seen at 90 days. Compared with the control group, the adjusted cOR for an improvement in modified Rankin Scale score (mRSC) at 90 days in the intervention group was 1.05 (95% CI 0.77–1.45; p=0.74). Andrei Alexandrov, MD (University of Tennessee Health Science Center, Memphis), and colleagues reported in the April 2019 issue of the Lancet Neurology. Continue reading →

The results of the STOP-DAPT 2 randomized controlled trial were presented by Dr. Hirotoshi Watanabe at the American College of Cardiology Annual Scientific Session (ACC 2019), at New Orleans, LA. According to the findings, 1-month DAPT was superior to 12-month DAPT in the prevention of net adverse ischemic events. Continue reading →

According to a presentation by Dr. Marc P. Bonaca at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA on March 18, 2019, patients with type 2 diabetes mellitus (T2DM) and prior MI are at high risk of major adverse cardiovascular events (MACE) and cardiovascular (CV) death/HHF. Dapagliflozin appears to robustly reduce the risk of both composite outcomes in these patients. These results were published online in Circulation. Continue reading →

A randomized multi-center trial which enrolled 1000 patients from 71 centers around the world has shown that in patients with severe aortic stenosis who are at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year is significantly lower with transcatheter aortic valve replacement (TAVR) than with surgery. Continue reading →

According to the results of the TREAT trial, among patients aged under 75 years with STEMI, administration of ticagrelor after fibrinolytic therapy did not significantly reduce the frequency of cardiovascular events in comparison with clopidogrel. The results of the 12-month analysis were recently published in the Journal of the American College of Cardiology. Continue reading →

The total event analysis from the REDUCE-IT trial, presented at ACC 2019 showed that among statin-treated patients with elevated triglycerides and cardiovascular disease or diabetes, icosapent ethyl substantially reduced the burden of first, subsequent, and total ischemic events. The results are exciting as this is one of the first non-LDL targeted trials to demonstrate a cardiovascular benefit, and is likely to be featured in future guidelines. Continue reading →

ACC 2019: In patients with atrial fibrillation and a recent acute coronary syndrome or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without signifi­cant differences in the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both, according to results of the AUGUSTUS trial presented at ACC.19 in New Orleans. The results were also published simultaneously in the New England Journal of Medicine. Continue reading →

The largest LVAD trial ever to be performed, led by Dr. Mandeep Mehra published the final analysis of a fully magnetically levitated left ventricular assist device in the New England Journal of Medicine. According to this, among patients with advanced heart failure, a fully magnetically levitated centrifugal- flow pump has been found to be superior to a mechanical-bearing axial-flow pump in advanced heart failure patients in terms of survival free of disabling stroke or reoperation for removal in case of device malfunction. Continue reading →

NEW ORLEANS — Transcatheter repair of functional mitral regurgitation (or secondary MR) with MitraClip improved quality of life and hemodynamics better than optimal medical therapy alone, COAPT trial analyses showed. Indeed, the COAPT QOL study showed that among patients with symptomatic HF and 3+ to 4+ secondary MR receiving maximally-tolerated medical therapy, edge-to-edge TMVr resulted in substantial early and sustained health status improvement compared with medical therapy alone. Continue reading →

The design of the HEARTLINE randomized trial of up to 180,000 pts for assessing the efficacy of the Apple Watch & educational initiatives to reduce a composite outcome of death, MI and stroke was presented by Dr. C. Michael Gibson, PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston, Massachusetts, at ACC 2019, in New Orleans,  LA earlier today. The HEARTLINE Study brings together Johnson & Johnson’s health and behavioral science expertise and long heritage in treating cardiovascular disease with Apple’s technology expertise. Emerging technology holds great potential to help identify people at risk for future disease and develop interventions to prevent disease before it occurs. Leveraging a new heart health app from Johnson & Johnson in combination with Apple Watch’s irregular rhythm notifications and ECG app, the HEARTLINE Study will seek to investigate whether this technology can accelerate the diagnosis of AFib and improve outcomes including the prevention of stroke, as well as assess the impact of a medication adherence program. The study will be conducted in the U.S. only and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older. Continue reading →

The results of a trial presented by Dr. Adam DeVore at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, reflected that among patients with heart failure with reduced ejection fraction who were hospitalized for acute decompensated heart failure, the initiation of sacubitril–valsartan therapy led to a greater reduction in the NT-proBNP concentration as compared with enalapril therapy. In addition to this, the rates of worsening renal function, hyperkalemia, symptomatic hypotension, and angioedema did not differ significantly between the two arms. Continue reading →

In an analysis of two randomized clinical trials published in JAMA cardiology, Fournier et al. reported that the larger the improvement in FFR, the larger the symptomatic relief and the lower the event rate. This was suggestive of the fact that measuring FFR before and after PCI could provide clinically useful information. Continue reading →

According to a randomized controlled trial led by Dr. Michael Gibson, PERFUSE Study Group, Beth Israel Deaconess Medical Center, Boston, Massachusetts, the implantable cardiac system was found to detect early ST-segment deviation and alert patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, the report published in the Journal of the American College of Cardiology provided evidence that the device was beneficial among high-risk subjects in the identification of asymptomatic events. Continue reading →

The results of the DECISION-CTO trial conducted by Lee et al. showcased that CTO-PCI was feasible with high success rates. In addition to this, there was no difference in the incidence of major adverse cardiovascular events with CTO PCI vs. no CTO-PCI, however, the study was limited by low power for clinical endpoints and high crossover rates between groups. The results were published online in Circulation. Continue reading →

A randomized double-blinded trial called Cardiovascular Inflammation Reduction Trial (CIRT) recently published in the New England Journal of Medicine by Ridker, M.D. and his colleges at  the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, Boston illustrated that that low-dose methotrexate did not reduce atherosclerotic events or any markers of inflammation such as interleukin-1β, interleukin-6, or C-reactive protein. Continue reading →

Among patients who had left-sided infective endocarditis (IE) caused by common bacteria, a shift from intravenous (IV) to oral antibiotic treatment was noninferior to continued IV antibiotic treatment, according to the open-label, randomized POET trial (Partial Oral Treatment of Endocarditis; ClinicalTrials.gov: NCT01375257). Contemporary practice guidelines from the US and Europe recommend a 4- to 6-week course of IV antibiotics for patients with a left-sided IE. Data from the POET trial suggest that oral antibiotics may be safely and effectively administered during approximately half of the recommended treatment period, and potentially as outpatient treatment. The study results were presented at the European Society of Cardiology Congress 2018 and published in the New England Journal of Medicine.

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A recent study published in the New England Journal of Medicine showed that among patients who were scheduled for CABG and had been randomly assigned to undergo bilateral or single internal-thoracic-artery grafting, there was no significant between-group difference in the rate of death from any cause at 10 years in the intention-to-treat analysis. Coronary-artery bypass grafting (CABG) surgery with the use of left internal- thoracic-artery grafts plus vein grafts had been deemed superior to percutaneous coronary intervention in patients with severe coronary artery disease and in those with diabetes. The benefit of using left internal thoracic artery grafts has been attributed to their superior long-term patency as compared with vein grafts. However, it is hypothesized that multiple arterial grafts may result in longer survival than single arterial grafts after coronary-artery bypass grafting (CABG) surgery. In the light of this, the study aimed to evaluate the use of bilateral internal-thoracic-artery grafts for CABG. Continue reading →

A multi-center randomized, double blind, placebo-controlled, parallel group clinical trial has shown that among patients with acute ST-elevation myocardial infarction (STEMI) presenting within 6 hours of symptoms, adjunctive low-dose intracoronary alteplase given after reperfusion via primary percutaneous intervention does not reduce microvascular obstruction. Continue reading →

COAPT trial

This prospective, multicenter, open-label, randomized trial aimed to assess the use of transcatheter mitral valve repair in heart failure (HF) patients with mitral regurgitation due to left ventricular dysfunction. A total of 614 patients were randomized to either receiving guideline-directed medical therapy (GDMT) alone or GDMT in addition to transcatheter mitral-valve repair. The primary efficacy endpoint was all hospitalizations due to heart failure at 24 months of follow-up, while the primary safety endpoint was freedom from device-related complications at 12 months of follow-up. The study showed that the device group had a lower risk of hospitalization for HF (HR 0.53, 95% CI 0.4-0.7) and all-cause mortality (HR 0.62, 95% CI 0.46-0.82) at 24 months. Moreover, the rate of freedom from device complications at 12 months was 96.6% which exceeded the prespecified safety threshold. Continue reading →